Trial Outcomes & Findings for Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir. (NCT NCT04847622)
NCT ID: NCT04847622
Last Updated: 2024-11-29
Results Overview
Occurrence of death within 28 days.
COMPLETED
451 participants
Day 28
2024-11-29
Participant Flow
Participant milestones
| Measure |
Cases
Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st, 2020.
1. Hospitalised after August 31st,2020
2. Received at least one dose of Remdesivir (RDV) at any time during hospitalisation
|
|---|---|
|
Overall Study
STARTED
|
448
|
|
Overall Study
COMPLETED
|
448
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the total 448 cases, 391 had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analysis
Baseline characteristics by cohort
| Measure |
Cases
n=448 Participants
Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st, 2020.
1. Hospitalised after August 31st,2020
2. Received at least one dose of Remdesivir (RDV) at any time during hospitalisation
|
|---|---|
|
Age, Continuous
|
65 Years
n=448 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=448 Participants
|
|
Sex: Female, Male
Male
|
286 Participants
n=448 Participants
|
|
Race/Ethnicity, Customized
White Caucasian
|
159 Participants
n=448 Participants
|
|
Race/Ethnicity, Customized
White Mixed
|
24 Participants
n=448 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=448 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=448 Participants
|
|
Race/Ethnicity, Customized
Other
|
230 Participants
n=448 Participants
|
|
Pregnant women, n (%)
|
0 Participants
n=448 Participants
|
|
Body mass index (BMI, Kg/m²)
|
28.4 Kg/m²
n=448 Participants
|
|
Comorbidities
Comorbidities
|
355 Participants
n=448 Participants
|
|
Comorbidities
Cardiovascular Disease excluding Hypertension
|
115 Participants
n=448 Participants
|
|
Comorbidities
Diabetes
|
138 Participants
n=448 Participants
|
|
Comorbidities
Hypertension
|
202 Participants
n=448 Participants
|
|
Comorbidities
Asthma
|
33 Participants
n=448 Participants
|
|
Comorbidities
COPD
|
29 Participants
n=448 Participants
|
|
Comorbidities
Severe renal disease
|
16 Participants
n=448 Participants
|
|
Comorbidities
Liver Disease
|
9 Participants
n=448 Participants
|
|
Comorbidities
HIV Infection
|
2 Participants
n=448 Participants
|
|
Comorbidities
Chemo/radiotherapy for cancer
|
46 Participants
n=448 Participants
|
|
Comorbidities
Receiving Immuno-Suppressive Agent (Not for Cancer)
|
19 Participants
n=448 Participants
|
|
Comorbidities
Obesity
|
74 Participants
n=448 Participants
|
|
Comorbidities
Dementia
|
15 Participants
n=448 Participants
|
|
NEWS2 score
Low
|
145 Participants
n=391 Participants • Of the total 448 cases, 391 had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analysis
|
|
NEWS2 score
Low-medium/Medium
|
146 Participants
n=391 Participants • Of the total 448 cases, 391 had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analysis
|
|
NEWS2 score
High
|
100 Participants
n=391 Participants • Of the total 448 cases, 391 had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analysis
|
|
SpO2 (%)
Low disease severity - No supplemental oxygen
|
81 Participants
n=448 Participants
|
|
SpO2 (%)
Medium disease severity - Low flow oxygen
|
295 Participants
n=448 Participants
|
|
SpO2 (%)
High disease severity - High flow oxygen
|
72 Participants
n=448 Participants
|
|
Other Treatment for COVID-19, n (%)
None
|
100 Participants
n=448 Participants
|
|
Other Treatment for COVID-19, n (%)
Corticosteroids
|
285 Participants
n=448 Participants
|
|
Other Treatment for COVID-19, n (%)
Tocilizimab /Sarilumab
|
18 Participants
n=448 Participants
|
|
Other Treatment for COVID-19, n (%)
Other COVID Treatment Related Drug
|
45 Participants
n=448 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Occurrence of death within 28 days.
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
All Case Mortality by Day 28
|
52 participants
|
5 participants
|
30 participants
|
17 participants
|
PRIMARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Number of hospital discharges by day 28.
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Duration of Hopitalisation
|
369 participants
|
69 participants
|
248 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Day 7Population: Hospitalised adult patients with COVID-19 who received at least one dose of remdesivir during their hospital admission.
Clinical status assessed by a 7-point ordinal scale on Day 7 7-point ordinary scale: 1. Death 2. Hospitalised, on invasive mechanical ventilation or ECMO 3. Hospitalised, on non-invasive ventilation or high flow oxygen devices 4. Hospitalised, requiring low flow supplemental oxygen 5. Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care 7. Not hospitalised A higher score indicates a better outcome
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 1
|
10 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 2
|
13 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 3
|
80 Participants
|
6 Participants
|
45 Participants
|
29 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 4
|
137 Participants
|
28 Participants
|
98 Participants
|
11 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 5
|
70 Participants
|
16 Participants
|
47 Participants
|
7 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 6
|
67 Participants
|
15 Participants
|
44 Participants
|
8 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Ordinal Scale 7
|
68 Participants
|
13 Participants
|
47 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 147-point ordinal scale: 1. Death 2. Hospitalised, on invasive mechanical ventilation or ECMO 3. Hospitalised, on non-invasive ventilation or high flow oxygen devices 4. Hospitalised, requiring low flow supplemental oxygen 5. Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care 7. Not hospitalised A higher score indicates a better outcome
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 1
|
36 Participants
|
5 Participants
|
17 Participants
|
14 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 2
|
15 Participants
|
1 Participants
|
13 Participants
|
1 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 3
|
22 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 4
|
44 Participants
|
8 Participants
|
28 Participants
|
8 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 5
|
38 Participants
|
11 Participants
|
26 Participants
|
1 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 6
|
85 Participants
|
11 Participants
|
56 Participants
|
18 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Ordinal Scale 7
|
206 Participants
|
40 Participants
|
142 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 7, 14, and 28Population: Of the total of 448 hospitalised adult COVID-19 patients who received at least one dose of remdesivir, these 391 (87%) had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analsis
NEWS2 is a summary score of six physiological parameters (respiratory rate, oxygen saturation, systolic blood pressure, heart rate, consciousness, temperature, and supplemental oxygen dependency). The parameters are assessed to generate a severity score classified as low: aggregate score 0-4, low - medium/medium: score of 3 in any individual parameter/aggregate score 5-6,high: aggregate score 7 or more. A higher score indicates a greater clinical risk. Clinical status assessed by a 7-point ordinal scale.7-point ordinary scale: 1. Death 2. Hospitalised,on invasive mechanical ventilation or ECMO 3. Hospitalised,on non-invasive ventilation or high flow oxygen devices 4. Hospitalised,requiring low flow supplemental oxygen 5. Hospitalised,not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalised,not requiring supplemental oxygen -no longer requires ongoing medical care 7. Not hospitalised A higher score indicates a better outcome.
Outcome measures
| Measure |
Overall
n=145 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=146 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=100 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=391 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 1 at day 7
|
2 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 2 at day 7
|
3 Participants
|
4 Participants
|
4 Participants
|
11 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 3 at day 7
|
26 Participants
|
26 Participants
|
24 Participants
|
76 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 4 at day 7
|
45 Participants
|
46 Participants
|
28 Participants
|
119 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 5 at day 7
|
25 Participants
|
16 Participants
|
14 Participants
|
55 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 6 at day 7
|
27 Participants
|
20 Participants
|
12 Participants
|
59 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 7 at day 7
|
17 Participants
|
31 Participants
|
14 Participants
|
62 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 1 at day 14
|
12 Participants
|
8 Participants
|
13 Participants
|
33 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 2 at day 14
|
2 Participants
|
8 Participants
|
3 Participants
|
13 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 3 at day 14
|
7 Participants
|
6 Participants
|
6 Participants
|
19 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 4 at day 14
|
15 Participants
|
14 Participants
|
10 Participants
|
39 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 5 at day 14
|
13 Participants
|
7 Participants
|
5 Participants
|
25 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 6 at day 14
|
28 Participants
|
32 Participants
|
21 Participants
|
81 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 7 at day 14
|
68 Participants
|
71 Participants
|
42 Participants
|
181 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 1 at day 28
|
14 Participants
|
14 Participants
|
19 Participants
|
47 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 2 at day 28
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 3 at day 28
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 4 at day 28
|
3 Participants
|
6 Participants
|
3 Participants
|
12 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 5 at day 28
|
3 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 6 at day 28
|
11 Participants
|
9 Participants
|
7 Participants
|
27 Participants
|
|
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Ordinal Scale 7 at day 28
|
112 Participants
|
110 Participants
|
67 Participants
|
289 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Hospitalised Adults with COVID-19 who received at least one dose of remdesivir.
Clinical status assessed by a 7-point ordinal clinical status scale on Day 28 (or at last observation if discharged or died prior to this time point) in those still hospitalised after Day 14 7-point ordinary scale: 1. Death 2. Hospitalised, on invasive mechanical ventilation or ECMO 3. Hospitalised, on non-invasive ventilation or high flow oxygen devices 4. Hospitalised, requiring low flow supplemental oxygen 5. Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care 7. Not hospitalised
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 1
|
52 Participants
|
5 Participants
|
30 Participants
|
17 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 2
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 3
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 4
|
14 Participants
|
1 Participants
|
9 Participants
|
4 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 5
|
8 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 6
|
27 Participants
|
5 Participants
|
15 Participants
|
7 Participants
|
|
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Ordinal Scale 7
|
333 Participants
|
64 Participants
|
227 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Adults with hospitalised COVID-19 who received at least one dose of remdesivir
Number of participants SpO2 \> 94% on room air by day 28
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
SpO2 > 94% on Room Air
|
154 Participants
|
22 Participants
|
113 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Median (IQR) duration on oxygen therapy by day 28.
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Duration of Oxygen Therapy
|
6 days
Interval 4.0 to 9.0
|
5 days
Interval 3.0 to 8.0
|
6 days
Interval 4.0 to 9.0
|
6 days
Interval 4.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Intensive care unit admission over entire study period
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
ICU Admission
|
55 participants
|
3 participants
|
33 participants
|
19 participants
|
SECONDARY outcome
Timeframe: through study completion, 28 daysPopulation: Hospitalised Adults with COVID-19 who received at least one dose of remdesivir.
Number of days spent in ICU
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Duration of ICU
|
13 days
Interval 8.0 to 19.0
|
10 days
Interval 7.0 to 11.0
|
17 days
Interval 10.0 to 17.0
|
10 days
Interval 6.0 to 16.0
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Mechanical Ventilation/ECMO Use
|
25 participants
|
3 participants
|
17 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Median (IQR) time from first symptoms to use of remdesivir
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Timing of Remdesivir Exposure
|
7 days
Interval 4.0 to 9.0
|
7 days
Interval 4.0 to 11.0
|
7 days
Interval 4.0 to 9.0
|
7 days
Interval 5.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Median (IQR) time from hospitalisation to use of remdesivir
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Timing From Hospitalisation to Remdesivir Exposure
|
1 days
Interval 0.0 to 2.0
|
2 days
Interval 1.0 to 3.0
|
1 days
Interval 0.0 to 2.0
|
1 days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Median (IQR) duration of use of remdesivir
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Duration of Remdesivir Use
|
5 days
Interval 4.0 to 5.0
|
5 days
Interval 4.0 to 6.0
|
5 days
Interval 4.0 to 5.0
|
5 days
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 28Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome
Outcome measures
| Measure |
Overall
n=448 Participants
Adults with COVID-19 hospitalised between August 31st and December 31st 2020 who received at least one dose of remdesivir.
|
Low Disease Severity at Baseline
n=81 Participants
No supplemental oxygen support (NSO)
|
Medium Disease Severity at Baseline
n=295 Participants
Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute)
|
High Disease Severity at Baseline
n=72 Participants
High disease severity at baseline defined by high flow oxygen support (\>6 litres (l)/minute
|
|---|---|---|---|---|
|
Readmission With COVID-19 Complications
|
16 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
Adverse Events
Control Group
Serious adverse events
| Measure |
Control Group
n=448 participants at risk
Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st 2020.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mortality
|
11.6%
52/448 • Number of events 52 • Day 28
All cause mortality was collected throughout the study period. All other adverse events (not including all cause mortality) were not collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Toni Sobande, Clinical Project Manager
Research Organisation King's Cross (KC) Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place