Trial Outcomes & Findings for Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients (NCT NCT05502081)
NCT ID: NCT05502081
Last Updated: 2023-07-25
Results Overview
Dead or alive
COMPLETED
PHASE4
265 participants
28 days
2023-07-25
Participant Flow
from 1/11/2021 to 29/5/2022 at isolation hospital, Mansoura university
assignment is applied after admission of participants
Participant milestones
| Measure |
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
Remdesivir
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
106
|
106
|
|
Overall Study
COMPLETED
|
53
|
106
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.34 years
STANDARD_DEVIATION 16.096 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 15.98 • n=7 Participants
|
65.02 years
STANDARD_DEVIATION 14.26 • n=5 Participants
|
60.88 years
STANDARD_DEVIATION 15.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Middle eastern
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Number of co-morbidities
0
|
10 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Number of co-morbidities
1
|
16 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Number of co-morbidities
2
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Number of co-morbidities
3
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Number of co-morbidities
4
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Number of co-morbidities
5
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Number of co-morbidities
6
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Method of diagnosis
symptoms
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Method of diagnosis
laboratory and radiology
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Method of diagnosis
polymerase chain reaction confirmed
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Severity of COVID-19
moderate
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Severity of COVID-19
severe
|
27 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Severity of COVID-19
critical
|
8 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
World health organization clinical progression scale
3
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
World health organization clinical progression scale
4
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
World health organization clinical progression scale
5
|
35 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
|
World health organization clinical progression scale
6
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Number of symptoms
2
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Number of symptoms
3
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Number of symptoms
4
|
32 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Number of symptoms
5
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Antibiotics use
yes
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Antibiotics use
no
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
macrolide use
yes
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
macrolide use
no
|
45 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
|
fluoroquinolone use
yes
|
41 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
fluoroquinolone use
no
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
cephalosporin use
yes
|
39 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
cephalosporin use
no
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
carbapenem use
yes
|
10 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
carbapenem use
no
|
43 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
piperacillin use
yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
piperacillin use
no
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
amoxicillin/ clavulanate use
yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
amoxicillin/ clavulanate use
no
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
co-trimoxazole use
yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
co-trimoxazole use
no
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
linezolide use
yes
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
linezolide use
no
|
48 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
244 Participants
n=4 Participants
|
|
teicoplanin use
yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
teicoplanin use
no
|
52 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Anticoagulant use
yes
|
49 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
246 Participants
n=4 Participants
|
|
Anticoagulant use
no
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
dose of anticoagulant
prophylactic
|
39 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
dose of anticoagulant
therapeutic
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Antiplatelet use
yes
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Antiplatelet use
no
|
48 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Steriods use
yes
|
45 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
|
Steriods use
no
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Additive therapy use
yes
|
51 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Additive therapy use
no
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
paracetamol use
yes
|
50 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
261 Participants
n=4 Participants
|
|
paracetamol use
no
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
zinc use
yes
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
zinc use
no
|
49 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
acetylcysteine use
yes
|
52 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
acetylcysteine use
no
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
lactoferrin use
yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
lactoferrin use
no
|
52 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
vitamin C use
yes
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
vitamin C use
no
|
49 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Oxygen therapy use
yes
|
37 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Oxygen therapy use
no
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Nasal Prongs use
yes
|
18 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Nasal Prongs use
no
|
35 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Simple Face Mask use
yes
|
30 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Simple Face Mask use
no
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Mask Reservoir use
yes
|
8 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Mask Reservoir use
no
|
45 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
High Flow Nasal Cannula use
yes
|
5 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
High Flow Nasal Cannula use
no
|
48 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Continuous Positive Attenuated Pressure use
yes
|
4 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Continuous Positive Attenuated Pressure use
no
|
49 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Invasive Mechanical Ventilation use
yes
|
1 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Invasive Mechanical Ventilation use
no
|
52 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
206 Participants
n=4 Participants
|
|
Vasopressor use
yes
|
0 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Vasopressor use
no
|
53 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Prone Positioning
yes
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Prone Positioning
no
|
53 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Heart rate
|
82.40 beats/ minute
STANDARD_DEVIATION 12.443 • n=5 Participants
|
85.7 beats/ minute
STANDARD_DEVIATION 16.072 • n=7 Participants
|
87.02 beats/ minute
STANDARD_DEVIATION 16.79 • n=5 Participants
|
85.04 beats/ minute
STANDARD_DEVIATION 15.1 • n=4 Participants
|
|
Respiratory rate
|
24.25 breaths/ minute
STANDARD_DEVIATION 3.246 • n=5 Participants
|
25.4 breaths/ minute
STANDARD_DEVIATION 5.58 • n=7 Participants
|
24.72 breaths/ minute
STANDARD_DEVIATION 5.012 • n=5 Participants
|
24.79 breaths/ minute
STANDARD_DEVIATION 4.612 • n=4 Participants
|
|
Body temperature
|
36.951 degree Celsius
STANDARD_DEVIATION 0.492 • n=5 Participants
|
36.938 degree Celsius
STANDARD_DEVIATION 0.456 • n=7 Participants
|
36.906 degree Celsius
STANDARD_DEVIATION 1.18 • n=5 Participants
|
36.92 degree Celsius
STANDARD_DEVIATION 0.709 • n=4 Participants
|
|
O2 saturation on Oxygen therapy
|
96.26 percentage of O2 saturation
STANDARD_DEVIATION 2.391 • n=5 Participants
|
95.86 percentage of O2 saturation
STANDARD_DEVIATION 3.795 • n=7 Participants
|
96.01 percentage of O2 saturation
STANDARD_DEVIATION 3.130 • n=5 Participants
|
96.04 percentage of O2 saturation
STANDARD_DEVIATION 3.105 • n=4 Participants
|
|
O2 saturation on Room air
|
92.36 percentage of O2 saturation
STANDARD_DEVIATION 4.816 • n=5 Participants
|
87.62 percentage of O2 saturation
STANDARD_DEVIATION 7.171 • n=7 Participants
|
88.35 percentage of O2 saturation
STANDARD_DEVIATION 7.006 • n=5 Participants
|
89.44 percentage of O2 saturation
STANDARD_DEVIATION 6.33 • n=4 Participants
|
|
Aspartate aminotransferase level
|
45.62 Units/liter
STANDARD_DEVIATION 38.619 • n=5 Participants
|
52.95 Units/liter
STANDARD_DEVIATION 35.49 • n=7 Participants
|
54.52 Units/liter
STANDARD_DEVIATION 67.85 • n=5 Participants
|
51.03 Units/liter
STANDARD_DEVIATION 47.319 • n=4 Participants
|
|
Alanine aminotransferase level
|
33.34 Units/liter
STANDARD_DEVIATION 27.166 • n=5 Participants
|
33.27 Units/liter
STANDARD_DEVIATION 22.826 • n=7 Participants
|
42.79 Units/liter
STANDARD_DEVIATION 77.37 • n=5 Participants
|
36.46 Units/liter
STANDARD_DEVIATION 42.454 • n=4 Participants
|
|
Bilirubin level
|
0.5472 milligram/deciliter
STANDARD_DEVIATION 0.299 • n=5 Participants
|
0.6228 milligram/deciliter
STANDARD_DEVIATION 0.79 • n=7 Participants
|
0.7327 milligram/deciliter
STANDARD_DEVIATION 0.69 • n=5 Participants
|
0.634 milligram/deciliter
STANDARD_DEVIATION 0.593 • n=4 Participants
|
|
Albumin level
|
3.1774 gram/deciliter
STANDARD_DEVIATION 0.461 • n=5 Participants
|
3.1715 gram/deciliter
STANDARD_DEVIATION 0.48 • n=7 Participants
|
3.1021 gram/deciliter
STANDARD_DEVIATION 0.512 • n=5 Participants
|
3.15 gram/deciliter
STANDARD_DEVIATION 0.484 • n=4 Participants
|
|
Prothrombin Time
|
14.575 seconds
STANDARD_DEVIATION 1.68 • n=5 Participants
|
15.338 seconds
STANDARD_DEVIATION 1.997 • n=7 Participants
|
15.69 seconds
STANDARD_DEVIATION 2.476 • n=5 Participants
|
15.201 seconds
STANDARD_DEVIATION 2.051 • n=4 Participants
|
|
International normalized ratio
|
1.2625 Ratio
STANDARD_DEVIATION 0.201 • n=5 Participants
|
1.3436 Ratio
STANDARD_DEVIATION 0.239 • n=7 Participants
|
1.3868 Ratio
STANDARD_DEVIATION 0.296 • n=5 Participants
|
1.33 Ratio
STANDARD_DEVIATION 0.245 • n=4 Participants
|
|
Serum creatinine
|
1.2092 milligram/deciliter
STANDARD_DEVIATION 1.355 • n=5 Participants
|
1.0999 milligram/deciliter
STANDARD_DEVIATION 0.924 • n=7 Participants
|
1.8807 milligram/deciliter
STANDARD_DEVIATION 1.912 • n=5 Participants
|
1.3966 milligram/deciliter
STANDARD_DEVIATION 1.397 • n=4 Participants
|
|
Total leukocytic count
|
8.6934 10^3 cells/mm^3
STANDARD_DEVIATION 4.129 • n=5 Participants
|
8.4562 10^3 cells/mm^3
STANDARD_DEVIATION 5.044 • n=7 Participants
|
11.0268 10^3 cells/mm^3
STANDARD_DEVIATION 9.4 • n=5 Participants
|
9.39 10^3 cells/mm^3
STANDARD_DEVIATION 6.191 • n=4 Participants
|
|
Lymphocyte count
|
0.9658 10^9 cells/L
STANDARD_DEVIATION 0.521 • n=5 Participants
|
0.9123 10^9 cells/L
STANDARD_DEVIATION 0.429 • n=7 Participants
|
1.4834 10^9 cells/L
STANDARD_DEVIATION 5.62 • n=5 Participants
|
1.12 10^9 cells/L
STANDARD_DEVIATION 2.19 • n=4 Participants
|
|
Hemoglobin level
|
12.59 gram/deciliter
STANDARD_DEVIATION 1.58 • n=5 Participants
|
12.44 gram/deciliter
STANDARD_DEVIATION 2.07 • n=7 Participants
|
11.94 gram/deciliter
STANDARD_DEVIATION 2.54 • n=5 Participants
|
12.32 gram/deciliter
STANDARD_DEVIATION 2.063 • n=4 Participants
|
|
Hematocrit level
|
39.317 percentage of total blood volume
STANDARD_DEVIATION 6.045 • n=5 Participants
|
36.975 percentage of total blood volume
STANDARD_DEVIATION 5.586 • n=7 Participants
|
35.259 percentage of total blood volume
STANDARD_DEVIATION 8.559 • n=5 Participants
|
37.18 percentage of total blood volume
STANDARD_DEVIATION 6.73 • n=4 Participants
|
|
Platelet count
|
234.913 10^3 cells/uL
STANDARD_DEVIATION 91.5 • n=5 Participants
|
211.613 10^3 cells/uL
STANDARD_DEVIATION 92.3 • n=7 Participants
|
217.591 10^3 cells/uL
STANDARD_DEVIATION 122 • n=5 Participants
|
221.37 10^3 cells/uL
STANDARD_DEVIATION 101.93 • n=4 Participants
|
|
Lactate dehydrogenase level
|
413.06 international units per liter
STANDARD_DEVIATION 294.7 • n=5 Participants
|
389.81 international units per liter
STANDARD_DEVIATION 222.668 • n=7 Participants
|
378.5 international units per liter
STANDARD_DEVIATION 250.183 • n=5 Participants
|
393.79 international units per liter
STANDARD_DEVIATION 255.85 • n=4 Participants
|
|
Creatine kinase level
|
185.96 Units/liter
STANDARD_DEVIATION 207.6 • n=5 Participants
|
228.07 Units/liter
STANDARD_DEVIATION 367.1 • n=7 Participants
|
232.75 Units/liter
STANDARD_DEVIATION 287 • n=5 Participants
|
215.59 Units/liter
STANDARD_DEVIATION 287.23 • n=4 Participants
|
|
D-dimer level
|
0.6189 μg/mL
STANDARD_DEVIATION 0.493 • n=5 Participants
|
0.1433 μg/mL
STANDARD_DEVIATION 0.227 • n=7 Participants
|
0.2915 μg/mL
STANDARD_DEVIATION 0.385 • n=5 Participants
|
0.351 μg/mL
STANDARD_DEVIATION 0.368 • n=4 Participants
|
|
C-reactive protein level
|
61.566 milligram/liter
STANDARD_DEVIATION 39.71 • n=5 Participants
|
61.292 milligram/liter
STANDARD_DEVIATION 35.3 • n=7 Participants
|
95.513 milligram/liter
STANDARD_DEVIATION 157.8 • n=5 Participants
|
72.79 milligram/liter
STANDARD_DEVIATION 77.60 • n=4 Participants
|
|
Ferritin level
|
442.34 micrograms per liter
STANDARD_DEVIATION 190.4 • n=5 Participants
|
418.06 micrograms per liter
STANDARD_DEVIATION 193.8 • n=7 Participants
|
1158.4 micrograms per liter
STANDARD_DEVIATION 6953 • n=5 Participants
|
672.93 micrograms per liter
STANDARD_DEVIATION 2445.73 • n=4 Participants
|
|
Sodium level
|
146.472 millimole/liter
STANDARD_DEVIATION 30.7 • n=5 Participants
|
145.243 millimole/liter
STANDARD_DEVIATION 20 • n=7 Participants
|
144.315 millimole/liter
STANDARD_DEVIATION 18.5 • n=5 Participants
|
145.34 millimole/liter
STANDARD_DEVIATION 23.06 • n=4 Participants
|
|
Potassium level
|
3.6228 millimole/liter
STANDARD_DEVIATION 0.514 • n=5 Participants
|
3.47 millimole/liter
STANDARD_DEVIATION 0.674 • n=7 Participants
|
3.79 millimole/liter
STANDARD_DEVIATION 0.829 • n=5 Participants
|
3.627 millimole/liter
STANDARD_DEVIATION 0.672 • n=4 Participants
|
|
arterial oxygen pressure
|
36.689 millimeters of mercury
STANDARD_DEVIATION 12.59 • n=5 Participants
|
37.325 millimeters of mercury
STANDARD_DEVIATION 14.6 • n=7 Participants
|
37.603 millimeters of mercury
STANDARD_DEVIATION 12.08 • n=5 Participants
|
37.205 millimeters of mercury
STANDARD_DEVIATION 13.09 • n=4 Participants
|
|
ratio of arterial Oxygen pressure to fraction inspired of Oxygen
|
223.5057 Ratio
STANDARD_DEVIATION 207 • n=5 Participants
|
156.7358 Ratio
STANDARD_DEVIATION 171 • n=7 Participants
|
164.142 Ratio
STANDARD_DEVIATION 138 • n=5 Participants
|
181.46 Ratio
STANDARD_DEVIATION 516 • n=4 Participants
|
|
Glasgow coma score
4
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Glasgow coma score
6
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Glasgow coma score
8
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Glasgow coma score
9
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Glasgow coma score
10
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Glasgow coma score
13
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Glasgow coma score
14
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Glasgow coma score
15
|
52 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Sequential organ function assessment
0
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sequential organ function assessment
1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sequential organ function assessment
2
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sequential organ function assessment
3
|
12 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sequential organ function assessment
4
|
17 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sequential organ function assessment
5
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sequential organ function assessment
6
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sequential organ function assessment
7
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sequential organ function assessment
8
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sequential organ function assessment
9
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sequential organ function assessment
10
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sequential organ function assessment
14
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysDead or alive
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
28-days Mortality Rate
dead
|
34 Participants
|
43 Participants
|
1 Participants
|
|
28-days Mortality Rate
alive
|
72 Participants
|
63 Participants
|
52 Participants
|
PRIMARY outcome
Timeframe: up to 60 dayspositive or negative
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Number of Participants With Positive or Negative Polymerase Chain Reaction (PCR) Test Results at End of Hospital Visit
positive
|
92 Participants
|
78 Participants
|
36 Participants
|
|
Number of Participants With Positive or Negative Polymerase Chain Reaction (PCR) Test Results at End of Hospital Visit
negative
|
14 Participants
|
28 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: up to 60 daysyes or no
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Number of Participants With Infusion Related Reactions, Hypersensitivity Reactions and Any Serious Adverse Events
yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Infusion Related Reactions, Hypersensitivity Reactions and Any Serious Adverse Events
no
|
106 Participants
|
106 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysyes or no
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Need for Invasive Mechanical Ventilation
yes
|
22 Participants
|
22 Participants
|
1 Participants
|
|
Need for Invasive Mechanical Ventilation
no
|
84 Participants
|
84 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysin days
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Oxygen Support Duration (Days)
|
9.2 days
Standard Deviation 7.107
|
7.46 days
Standard Deviation 5.077
|
3.72 days
Standard Deviation 3.527
|
SECONDARY outcome
Timeframe: up to 60 daysin days WHO disease ordinal progression scale 0= Uninfected Ambulatory mild disease 1. Asymptomatic; viral RNA detected 2. Symptomatic; independent. 3. Symptomatic; assistance needed Hospitalized: moderate disease 4. Hospitalized; no oxygen therapy 5. Hospitalized; oxygen by mask or nasal prongs Hospitalized: sever disease 6. Hospitalized; oxygen by NIV or high flow 7. Intubation and mechanical ventilation, pO2 /FIO2 ≥ 150 or Spo2 /FiO2 ≥200 8. Mechanical ventilation pO2/FiO2 \<150 (SpO2 /FiO2 \< 200) or vasopressors 9. Mechanical ventilation pO2 / FiO2 \< 150 and vasopressors, dialysis or ECMO Dead 10. Dead
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Time to Clinical Improvement (Defined as 2 Points Reduction in the WHO Disease Ordinal Progression Scale or Discharge, Whatever Happens First
|
8.33 days
Standard Deviation 6.38
|
7.75 days
Standard Deviation 4.265
|
7.4 days
Standard Deviation 3.101
|
SECONDARY outcome
Timeframe: up to 60 daysin days
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Duration of Hospitalization
|
11.85 days
Standard Deviation 6.264
|
10.59 days
Standard Deviation 5.26
|
8.94 days
Standard Deviation 3.165
|
SECONDARY outcome
Timeframe: Day 3minimum 0 to maximum 24, higher scores mean worse outcomes Platelets, ×10³/µL ≥150 0 100-149+1 50-99+2 20-49+3 \<20+4 Glasgow Coma Scale If on sedatives, estimate assumed GCS off sedatives 15 0 13-14+1 10-12+2 6-9+3 \<6+4 Bilirubin, mg/dL (μmol/L) \<1.2 (\<20) 0 1.2-1.9 (20-32)+1 2.0-5.9 (33-101)+2 6.0-11.9 (102-204)+3 ≥12.0 (\>204)+4 Mean arterial pressure OR administration of vasoactive agents required Listed doses are in units of mcg/kg/min No hypotension 0 MAP \<70 mmHg+1 DOPamine ≤5 or DOBUTamine (any dose)+2 DOPamine \>5, EPINEPHrine ≤0.1, or norEPINEPHrine ≤0.1+3 DOPamine \>15, EPINEPHrine \>0.1, or norEPINEPHrine \>0.1+4 Creatinine, mg/dL (μmol/L) (or urine output) \<1.2 (\<110) 0 1.2-1.9 (110-170)+1 2.0-3.4 (171-299)+2 3.5-4.9 (300-440) or UOP \<500 mL/day+3 ≥5.0 (\>440) or UOP \<200 mL/day+4
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
0
|
1 Participants
|
1 Participants
|
12 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
1
|
8 Participants
|
6 Participants
|
3 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
2
|
12 Participants
|
8 Participants
|
12 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
3
|
24 Participants
|
16 Participants
|
18 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
4
|
40 Participants
|
18 Participants
|
6 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
5
|
4 Participants
|
16 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
6
|
5 Participants
|
11 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
7
|
4 Participants
|
12 Participants
|
1 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
8
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
9
|
1 Participants
|
7 Participants
|
1 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
10
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
11
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
12
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
13
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 3
16
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3minimum 0 to maximum 10, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=52 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 4
|
17 Participants
|
17 Participants
|
25 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 5
|
57 Participants
|
58 Participants
|
20 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 6
|
28 Participants
|
22 Participants
|
7 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 8
|
0 Participants
|
5 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 9
|
2 Participants
|
4 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3
WHO scale 10
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) at Day 3
|
48.67 Units/liter
Standard Deviation 41.128
|
43.93 Units/liter
Standard Deviation 36.497
|
48.53 Units/liter
Standard Deviation 60.487
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Ferritin at Day 3
|
427.25 micrograms per liter
Standard Deviation 194.8
|
1110 micrograms per liter
Standard Deviation 6784.6
|
393.04 micrograms per liter
Standard Deviation 170.2
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Lactate Dehydrogenase (LDH) at Day 3
|
404.45 international units per liter
Standard Deviation 214.92
|
354.7 international units per liter
Standard Deviation 204.2
|
351.27 international units per liter
Standard Deviation 258.57
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
D-dimer at Day 3
|
0.23 μg/mL
Standard Deviation 0.3321
|
0.29 μg/mL
Standard Deviation 0.3845
|
0.244 μg/mL
Standard Deviation 0.2211
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) at Day 3
|
36.46 Units/liter
Standard Deviation 32.585
|
36.16 Units/liter
Standard Deviation 49.86
|
33.62 Units/liter
Standard Deviation 34.535
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Albumin at Day 3
|
2.947 gm/dl
Standard Deviation 0.4507
|
2.854 gm/dl
Standard Deviation 0.504
|
3.157 gm/dl
Standard Deviation 0.3858
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Bilirubin at Day 3
|
0.6457 milligram/deciliter
Standard Deviation 0.654
|
0.7053 milligram/deciliter
Standard Deviation 0.86
|
0.4793 milligram/deciliter
Standard Deviation 0.255
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=82 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=52 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
C-reactive Protein (CRP) at Day 3
|
52.61 milligram/liter
Standard Deviation 37.719
|
64.1 milligram/liter
Standard Deviation 63.035
|
33.89 milligram/liter
Standard Deviation 31.44
|
SECONDARY outcome
Timeframe: up to 60 daysduration of ICU stay
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Duration of Intensive Care Unit (ICU) Stay
|
7.6 days
Standard Deviation 7.614
|
6.69 days
Standard Deviation 6.23
|
1.45 days
Standard Deviation 1.835
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
C-reactive Protein (CRP) at Day 7
|
47.43 milligram/liter
Standard Deviation 52.631
|
65.73 milligram/liter
Standard Deviation 90.34
|
14.06 milligram/liter
Standard Deviation 14.548
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
C-reactive Protein (CRP) at Day 14
|
37.05 milligram/liter
Standard Deviation 55.395
|
39.31 milligram/liter
Standard Deviation 54.77
|
7.5 milligram/liter
Standard Deviation 5.745
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
C-reactive Protein (CRP) at Day 28
|
39 milligram/liter
Standard Deviation 38.419
|
96 milligram/liter
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated
|
—
|
SECONDARY outcome
Timeframe: day 7minimum 0 to maximum 24, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
0
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
1
|
4 Participants
|
4 Participants
|
18 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
2
|
10 Participants
|
10 Participants
|
12 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
3
|
13 Participants
|
13 Participants
|
3 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
4
|
28 Participants
|
7 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
5
|
7 Participants
|
7 Participants
|
1 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
6
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
11
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
12
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
13
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
14
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
15
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
16
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
7
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
8
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
9
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment (SOFA) Score on Day 7
10
|
4 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 14minimum 0 to maximum 24, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=16 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
0
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
1
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
2
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
3
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
4
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
5
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
6
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
8
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
9
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
11
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
14
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 14
16
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
minimum 0 to maximum 24, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Sequential Organ Function Assessment Score (SOFA) on Day 28
0
|
1 Participants
|
0 Participants
|
—
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 28
3
|
1 Participants
|
0 Participants
|
—
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 28
12
|
1 Participants
|
0 Participants
|
—
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 28
13
|
1 Participants
|
0 Participants
|
—
|
|
Sequential Organ Function Assessment Score (SOFA) on Day 28
17
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: day 7minimum 0 to maximum 10, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7
4
|
20 Participants
|
21 Participants
|
28 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7
9
|
7 Participants
|
4 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7
10
|
0 Participants
|
6 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7
5
|
28 Participants
|
22 Participants
|
11 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7
6
|
26 Participants
|
16 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7
8
|
3 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 14minimum 0 to maximum 10, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=16 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 14
4
|
2 Participants
|
7 Participants
|
4 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 14
5
|
8 Participants
|
4 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 14
6
|
3 Participants
|
1 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 14
8
|
3 Participants
|
1 Participants
|
0 Participants
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 14
9
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
minimum 0 to maximum 10, higher scores mean worse outcomes
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 28
5
|
2 Participants
|
0 Participants
|
—
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 28
9
|
2 Participants
|
0 Participants
|
—
|
|
COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 28
10
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) at Day 7
|
35.26 Units/liter
Standard Deviation 20.089
|
41.35 Units/liter
Standard Deviation 39.78
|
41.77 Units/liter
Standard Deviation 32.465
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) at Day 14
|
22.79 Units/liter
Standard Deviation 13.319
|
30.19 Units/liter
Standard Deviation 16.802
|
26.75 Units/liter
Standard Deviation 18.118
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) at Day 28
|
31 Units/liter
Standard Deviation 11.605
|
27 Units/liter
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated
|
—
|
SECONDARY outcome
Timeframe: day 7Continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) at Day 7
|
30.54 Units/liter
Standard Deviation 23.062
|
33.90 Units/liter
Standard Deviation 33.58
|
26 Units/liter
Standard Deviation 18.604
|
SECONDARY outcome
Timeframe: day 14Continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) at Day 14
|
22.42 Units/liter
Standard Deviation 15.788
|
35.38 Units/liter
Standard Deviation 17.55
|
15.75 Units/liter
Standard Deviation 4.856
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
Continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) at Day 28
|
71.75 Units/liter
Standard Deviation 57
|
39.5 Units/liter
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated
|
—
|
SECONDARY outcome
Timeframe: day 7Continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Bilirubin at Day 7
|
0.6575 milligram/deciliter
Standard Deviation 0.699
|
0.8886 milligram/deciliter
Standard Deviation 1.54
|
0.3717 milligram/deciliter
Standard Deviation 0.221
|
SECONDARY outcome
Timeframe: day 14Continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Bilirubin at Day 14
|
0.494 milligram/deciliter
Standard Deviation 0.2229
|
0.6888 milligram/deciliter
Standard Deviation 0.37
|
0.3625 milligram/deciliter
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Bilirubin at Day 28
|
0.41 milligram/deciliter
Standard Deviation 0.14376
|
1.67 milligram/deciliter
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated
|
—
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Albumin at Day 7
|
2.77 gm/dl
Standard Deviation 0.4837
|
2.644 gm/dl
Standard Deviation 0.489
|
2.98 gm/dl
Standard Deviation 0.4073
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Albumin at Day 14
|
2.82 gm/dl
Standard Deviation 0.4184
|
2.813 gm/dl
Standard Deviation 0.368
|
3.425 gm/dl
Standard Deviation 0.2872
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Albumin at Day 28
|
2.575 gm/dl
Standard Deviation 0.3304
|
2.7 gm/dl
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated
|
—
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Platelets at Day 3
|
253.425 10^3 cells/uL
Standard Deviation 105
|
226.35 10^3 cells/uL
Standard Deviation 116.2
|
271.64 10^3 cells/uL
Standard Deviation 97.62
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Platelets at Day 7
|
243.514 10^3 cells/uL
Standard Deviation 116.2
|
212.76 10^3 cells/uL
Standard Deviation 123.2
|
268.829 10^3 cells/uL
Standard Deviation 93.9
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Platelets at Day 14
|
216.95 10^3 cells/uL
Standard Deviation 126.3
|
215.63 10^3 cells/uL
Standard Deviation 126.3
|
248 10^3 cells/uL
Standard Deviation 136.48
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Platelets at Day 28
|
246.75 10^3 cells/uL
Standard Deviation 113
|
15 10^3 cells/uL
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Serum Creatinine (S.Cr) at Day 3
|
0.9546 milligram/deciliter
Standard Deviation 0.865
|
1.6568 milligram/deciliter
Standard Deviation 1.776
|
1.0769 milligram/deciliter
Standard Deviation 0.941
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Serum Creatinine (S.Cr) at Day 7
|
0.9952 milligram/deciliter
Standard Deviation 0.987
|
1.6541 milligram/deciliter
Standard Deviation 1.9
|
0.9674 milligram/deciliter
Standard Deviation 0.752
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Serum Creatinine (S.Cr) at Day 14
|
0.6316 milligram/deciliter
Standard Deviation 0.152
|
1.45 milligram/deciliter
Standard Deviation 1.7753
|
0.775 milligram/deciliter
Standard Deviation 0.221
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Serum Creatinine (S.Cr) at Day 28
|
0.525 milligram/deciliter
Standard Deviation 0.1708
|
1.2 milligram/deciliter
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
D-dimer at Day 7
|
0.319 μg/mL
Standard Deviation 0.5017
|
0.425 μg/mL
Standard Deviation 0.5678
|
0.109 μg/mL
Standard Deviation 0.1483
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
D-dimer at Day 14
|
0.41 μg/mL
Standard Deviation 0.5999
|
0.313 μg/mL
Standard Deviation 0.461
|
0.05 μg/mL
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
D-dimer at Day 28
|
0.4 μg/mL
Standard Deviation 0.8
|
0.4 μg/mL
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Creatine Kinase (Ck) at Day 3
|
197.94 Units/liter
Standard Deviation 342.1
|
181.45 Units/liter
Standard Deviation 166
|
142.2 Units/liter
Standard Deviation 135.12
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Creatine Kinase (Ck) at Day 7
|
211.9 Units/liter
Standard Deviation 420.23
|
175.99 Units/liter
Standard Deviation 155
|
126.743 Units/liter
Standard Deviation 112
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Creatine Kinase (Ck) at Day 14
|
122.89 Units/liter
Standard Deviation 93.259
|
142.75 Units/liter
Standard Deviation 176
|
49.5 Units/liter
Standard Deviation 30.116
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Creatine Kinase (Ck) at Day 28
|
119.22 Units/liter
Standard Deviation 88.21
|
134.25 Units/liter
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Lactate Dehydrogenase (LDH) at Day 7
|
371.37 international units per liter
Standard Deviation 196.2
|
349.68 international units per liter
Standard Deviation 201
|
271.4 international units per liter
Standard Deviation 165.99
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Lactate Dehydrogenase (LDH) at Day 14
|
360.89 international units per liter
Standard Deviation 244.8
|
306.88 international units per liter
Standard Deviation 266
|
379.75 international units per liter
Standard Deviation 313.9
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Lactate Dehydrogenase (LDH) at Day 28
|
314.5 international units per liter
Standard Deviation 108.99
|
270 international units per liter
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Ferritin at Day 7
|
450.37 micrograms per liter
Standard Deviation 247.6
|
1433 micrograms per liter
Standard Deviation 8174
|
368.42 micrograms per liter
Standard Deviation 167.8
|
SECONDARY outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Ferritin at Day 14
|
637.37 micrograms per liter
Standard Deviation 436
|
519.88 micrograms per liter
Standard Deviation 431
|
398.5 micrograms per liter
Standard Deviation 131.43
|
SECONDARY outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Ferritin at Day 28
|
1355 micrograms per liter
Standard Deviation 896.3
|
410 micrograms per liter
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: up to 60 daysIncidence of acute kidney injury (AKI)
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Incidence of Acute Kidney Injury (AKI)
yes
|
4 Participants
|
7 Participants
|
1 Participants
|
|
Incidence of Acute Kidney Injury (AKI)
no
|
102 Participants
|
99 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysIncidence of acute liver damage (ALD)
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Incidence of Acute Liver Damage (ALD)
yes
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Incidence of Acute Liver Damage (ALD)
no
|
100 Participants
|
103 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysday of death
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Day of Death
|
12.57 day
Standard Deviation 6.22
|
10.13 day
Standard Deviation 6.530
|
0.19 day
Standard Deviation 1.061
|
SECONDARY outcome
Timeframe: up to 60 daysmortality at discharge
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Mortality at Discharge
dead
|
33 Participants
|
41 Participants
|
1 Participants
|
|
Mortality at Discharge
alive
|
73 Participants
|
65 Participants
|
52 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 3minimum 0 to maximum 15, higher scores mean better outcomes
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Glasgow Coma Score (GCS) at Day 3
3
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
6
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
8
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
9
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
10
|
2 Participants
|
10 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
13
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
14
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Glasgow Coma Score (GCS) at Day 3
15
|
94 Participants
|
77 Participants
|
51 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 3continuous level
Outcome measures
| Measure |
Remdesivir
n=106 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=106 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=53 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Arterial Oxygen Pressure / Fraction Inspired of Oxygen (PaO2/FiO2) at Day 3
|
154.14 Ratio
Standard Deviation 138.9
|
166.96 Ratio
Standard Deviation 130
|
298.57 Ratio
Standard Deviation 211.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 7continuous level
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Arterial Oxygen Pressure / Fraction Inspired of Oxygen (PaO2/FiO2) at Day 7
|
163.55 Ratio
Standard Deviation 172.6
|
178.59 Ratio
Standard Deviation 138
|
320.62 Ratio
Standard Deviation 93.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 14continuous level
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Arterial Oxygen Pressure / Fraction Inspired of Oxygen (PaO2/FiO2) at Day 14
|
154.67 Ratio
Standard Deviation 174
|
165.2 Ratio
Standard Deviation 98.87
|
389.75 Ratio
Standard Deviation 51.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
continuous level
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Arterial Oxygen Pressure / Fraction Inspired of Oxygen (PaO2/FiO2) at Day 28
|
172.75 Ratio
Standard Deviation 181
|
53 Ratio
Standard Deviation NA
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 7minimum 0 to maximum 15, higher scores mean better outcomes
Outcome measures
| Measure |
Remdesivir
n=84 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=74 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=39 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Glasgow Coma Score (GCS) at Day 7
3
|
10 Participants
|
13 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
6
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
9
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
10
|
3 Participants
|
11 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
13
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
14
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 7
15
|
66 Participants
|
42 Participants
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 14minimum 0 to maximum 15, higher scores mean better outcomes
Outcome measures
| Measure |
Remdesivir
n=19 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=13 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
n=4 Participants
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Glasgow Coma Score (GCS) at Day 14
3
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 14
10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 14
13
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Glasgow Coma Score (GCS) at Day 14
15
|
11 Participants
|
7 Participants
|
4 Participants
|
|
Glasgow Coma Score (GCS) at Day 14
14
|
1 Participants
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 28Population: patients who received casirivimab and imdevimab, not stayed at hospital until day of 28
minimum 0 to maximum 15, higher scores mean better outcomes
Outcome measures
| Measure |
Remdesivir
n=4 Participants
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Remdesivir: antiviral drug
|
Favipravir
n=1 Participants
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Favipiravir: antiviral drug
|
Casirivimab and Imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Casirivimab and Imdevimab Drug Combination: antiviral Monoclonal Antibodies
|
|---|---|---|---|
|
Glasgow Coma Score (GCS) at Day 28
3
|
2 Participants
|
1 Participants
|
—
|
|
Glasgow Coma Score (GCS) at Day 28
15
|
2 Participants
|
NA Participants
Standard Deviation not calculable as only 1 participant was analyzed
|
—
|
Adverse Events
Casirivimab and Imdevimab
Remdesivir
Favipravir
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place