Trial Outcomes & Findings for Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma (NCT NCT04803370)
NCT ID: NCT04803370
Last Updated: 2025-09-29
Results Overview
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Day 7
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Control Group
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
Standard treatment for COVID-19: The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-IL-6 monoclonal antibody, oxygen therapy, etc..)
|
Intervention Group
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
Convalescent Plasma with antibody against SARS-CoV-2.: Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19.
The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
38
|
|
Overall Study
COMPLETED
|
17
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 3 • n=17 Participants
|
58 years
STANDARD_DEVIATION 2 • n=37 Participants
|
58 years
STANDARD_DEVIATION 1.87 • n=54 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=17 Participants
|
14 Participants
n=37 Participants
|
21 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=17 Participants
|
23 Participants
n=37 Participants
|
33 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
30.34 kg/m^2
STANDARD_DEVIATION 1.99 • n=17 Participants
|
30.72 kg/m^2
STANDARD_DEVIATION 1.24 • n=37 Participants
|
30.62 kg/m^2
STANDARD_DEVIATION 1.05 • n=54 Participants
|
|
Concomitant illnesses
Yes
|
14 Participants
n=17 Participants
|
27 Participants
n=37 Participants
|
41 Participants
n=54 Participants
|
|
Concomitant illnesses
No
|
3 Participants
n=17 Participants
|
10 Participants
n=37 Participants
|
13 Participants
n=54 Participants
|
|
Concomitant medication
Yes
|
7 Participants
n=17 Participants
|
17 Participants
n=37 Participants
|
24 Participants
n=54 Participants
|
|
Concomitant medication
No
|
10 Participants
n=17 Participants
|
20 Participants
n=37 Participants
|
30 Participants
n=54 Participants
|
|
Smoke
Yes
|
1 Participants
n=17 Participants
|
2 Participants
n=37 Participants
|
3 Participants
n=54 Participants
|
|
Smoke
No
|
16 Participants
n=17 Participants
|
35 Participants
n=37 Participants
|
51 Participants
n=54 Participants
|
|
Drug abuse habits
Yes
|
1 Participants
n=17 Participants
|
2 Participants
n=37 Participants
|
3 Participants
n=54 Participants
|
|
Drug abuse habits
No
|
16 Participants
n=17 Participants
|
35 Participants
n=37 Participants
|
51 Participants
n=54 Participants
|
|
Standard treatment
Antiinflammatory
|
11 participants
n=17 Participants
|
29 participants
n=37 Participants
|
40 participants
n=54 Participants
|
|
Standard treatment
Antiviral
|
5 participants
n=17 Participants
|
14 participants
n=37 Participants
|
19 participants
n=54 Participants
|
|
Standard treatment
Antibiotic
|
3 participants
n=17 Participants
|
10 participants
n=37 Participants
|
13 participants
n=54 Participants
|
|
Standard treatment
Anticoagulant
|
5 participants
n=17 Participants
|
13 participants
n=37 Participants
|
18 participants
n=54 Participants
|
|
Standard treatment
Oxygen therapy
|
10 participants
n=17 Participants
|
19 participants
n=37 Participants
|
29 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Day 7The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 1
|
0 Participants
|
0 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 2
|
0 Participants
|
0 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 3
|
2 Participants
|
3 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 4
|
5 Participants
|
6 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 5
|
4 Participants
|
10 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 6
|
2 Participants
|
3 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 7
|
1 Participants
|
3 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 8
|
3 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 14The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 1
|
0 Participants
|
0 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 2
|
1 Participants
|
0 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 3
|
0 Participants
|
2 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 4
|
1 Participants
|
2 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 5
|
1 Participants
|
3 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 6
|
3 Participants
|
3 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 7
|
5 Participants
|
9 Participants
|
|
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Grade 8
|
6 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: At inclusion, Day 21The levels of Anti-SARS-CoV-2 S IgG serum
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Anti-SARS-CoV-2 S IgG Serum Titer
At inclusion
|
90.28 AU/ ml
Standard Error 53.51
|
98.16 AU/ ml
Standard Error 39.89
|
|
Anti-SARS-CoV-2 S IgG Serum Titer
Day 21
|
773.84 AU/ ml
Standard Error 327.53
|
1102.81 AU/ ml
Standard Error 194.51
|
SECONDARY outcome
Timeframe: Day 21time that the patients have passed in the hospital.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Time of Hospitalization
|
10.5 days
Standard Error 1.8
|
8.9 days
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Day 21total time elapsed until negative RT-PCR test
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Time to Negativization of RT-PCR
|
14.6 days
Standard Error 2.1
|
12.4 days
Standard Error 1.4
|
SECONDARY outcome
Timeframe: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21the pressure of blood in the artery when the heart relaxes between beats.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Diastolic Blood Pressure
At inclusion
|
79.62 mmHg
Standard Error 3.17
|
75.21 mmHg
Standard Error 2.12
|
|
Diastolic Blood Pressure
Day 1
|
77.18 mmHg
Standard Error 5.01
|
74.83 mmHg
Standard Error 1.72
|
|
Diastolic Blood Pressure
Day 3
|
75.25 mmHg
Standard Error 2.84
|
74.33 mmHg
Standard Error 2.08
|
|
Diastolic Blood Pressure
Day 7
|
81.07 mmHg
Standard Error 3.53
|
72.48 mmHg
Standard Error 1.38
|
|
Diastolic Blood Pressure
Day 14
|
80.72 mmHg
Standard Error 5.06
|
78.96 mmHg
Standard Error 1.71
|
|
Diastolic Blood Pressure
Day 21
|
83.83 mmHg
Standard Error 3.91
|
81.85 mmHg
Standard Error 1.82
|
SECONDARY outcome
Timeframe: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Systolic Blood Pressure
At inclusion
|
130.62 mmHg
Standard Error 5.84
|
121.11 mmHg
Standard Error 3.25
|
|
Systolic Blood Pressure
Day 1
|
135 mmHg
Standard Error 7.53
|
123.87 mmHg
Standard Error 3.25
|
|
Systolic Blood Pressure
Day 3
|
134.2 mmHg
Standard Error 3.34
|
121.94 mmHg
Standard Error 2.15
|
|
Systolic Blood Pressure
Day 7
|
141.53 mmHg
Standard Error 6.85
|
119.48 mmHg
Standard Error 2.82
|
|
Systolic Blood Pressure
Day 14
|
145.8 mmHg
Standard Error 6.57
|
125.77 mmHg
Standard Error 2.56
|
|
Systolic Blood Pressure
Day 21
|
145.81 mmHg
Standard Error 6.01
|
128.39 mmHg
Standard Error 2.84
|
SECONDARY outcome
Timeframe: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Temperature
At inclusion
|
36.79 degrees Celsius
Standard Error 0.26
|
36.43 degrees Celsius
Standard Error 0.14
|
|
Temperature
Day 1
|
36.59 degrees Celsius
Standard Error 0.14
|
36.48 degrees Celsius
Standard Error 0.09
|
|
Temperature
Day 3
|
36.61 degrees Celsius
Standard Error 0.19
|
36.50 degrees Celsius
Standard Error 0.11
|
|
Temperature
Day 7
|
36.24 degrees Celsius
Standard Error 0.17
|
36.17 degrees Celsius
Standard Error 0.09
|
|
Temperature
Day 14
|
36.58 degrees Celsius
Standard Error 0.18
|
36.46 degrees Celsius
Standard Error 0.10
|
|
Temperature
Day 21
|
36.26 degrees Celsius
Standard Error 0.10
|
36.38 degrees Celsius
Standard Error 0.10
|
SECONDARY outcome
Timeframe: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Cardiac Frequency
At inclusion
|
83.37 beats/minit
Standard Error 4.05
|
79.82 beats/minit
Standard Error 2.25
|
|
Cardiac Frequency
Day 1
|
75.54 beats/minit
Standard Error 4.08
|
79.57 beats/minit
Standard Error 2.34
|
|
Cardiac Frequency
Day 3
|
77.31 beats/minit
Standard Error 3.16
|
73.73 beats/minit
Standard Error 2.10
|
|
Cardiac Frequency
Day 7
|
79.77 beats/minit
Standard Error 4.28
|
68.35 beats/minit
Standard Error 2.24
|
|
Cardiac Frequency
Day 14
|
86.27 beats/minit
Standard Error 5.71
|
85.38 beats/minit
Standard Error 2.66
|
|
Cardiac Frequency
Day 21
|
84.90 beats/minit
Standard Error 5.31
|
86.72 beats/minit
Standard Error 3.01
|
SECONDARY outcome
Timeframe: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21Number of breaths the patient takes per minute.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Respiratory Frequency
At inclusion
|
20.06 breath/minut
Standard Error 1.27
|
22.42 breath/minut
Standard Error 1.25
|
|
Respiratory Frequency
Day 1
|
22.36 breath/minut
Standard Error 1.20
|
23.61 breath/minut
Standard Error 1.13
|
|
Respiratory Frequency
Day 3
|
20.23 breath/minut
Standard Error 0.92
|
22.65 breath/minut
Standard Error 0.98
|
|
Respiratory Frequency
Day 7
|
21.12 breath/minut
Standard Error 1.29
|
19.95 breath/minut
Standard Error 1.05
|
|
Respiratory Frequency
Day 14
|
18.16 breath/minut
Standard Error 1.27
|
18.42 breath/minut
Standard Error 0.66
|
|
Respiratory Frequency
Day 21
|
16.43 breath/minut
Standard Error 0.61
|
19.38 breath/minut
Standard Error 1.11
|
SECONDARY outcome
Timeframe: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Oxygen Saturation
At inclusion
|
95.31 percentage of blood oxygen
Standard Error 0.73
|
95.4 percentage of blood oxygen
Standard Error 0.42
|
|
Oxygen Saturation
Day 1
|
95.63 percentage of blood oxygen
Standard Error 0.67
|
95.21 percentage of blood oxygen
Standard Error 0.94
|
|
Oxygen Saturation
Day 3
|
95.18 percentage of blood oxygen
Standard Error 0.51
|
95.78 percentage of blood oxygen
Standard Error 0.38
|
|
Oxygen Saturation
Day 7
|
94.69 percentage of blood oxygen
Standard Error 0.82
|
95.82 percentage of blood oxygen
Standard Error 0.42
|
|
Oxygen Saturation
Day 14
|
95.1 percentage of blood oxygen
Standard Error 0.54
|
95.73 percentage of blood oxygen
Standard Error 0.43
|
|
Oxygen Saturation
Day 21
|
96 percentage of blood oxygen
Standard Error 0.52
|
96.15 percentage of blood oxygen
Standard Error 0.37
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21hemoglobin levels in the blood
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Hemoglobin
Day 21
|
12.51 g/dL
Standard Error 0.4
|
13.04 g/dL
Standard Error 0.37
|
|
Hemoglobin
At inclusion
|
13.38 g/dL
Standard Error 0.31
|
13.45 g/dL
Standard Error 0.29
|
|
Hemoglobin
Day 3
|
13.05 g/dL
Standard Error 0.34
|
12.83 g/dL
Standard Error 0.31
|
|
Hemoglobin
Day 7
|
12.98 g/dL
Standard Error 0.37
|
13.21 g/dL
Standard Error 0.35
|
|
Hemoglobin
Day 14
|
12.94 g/dL
Standard Error 0.31
|
13.37 g/dL
Standard Error 0.28
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21Leucocyte count a patient's blood.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Leucocytes
At inclusion
|
7.81 cells x10^9/L
Standard Error 0.87
|
7.40 cells x10^9/L
Standard Error 0.46
|
|
Leucocytes
Day 3
|
8.31 cells x10^9/L
Standard Error 0.90
|
8.67 cells x10^9/L
Standard Error 0.65
|
|
Leucocytes
Day 7
|
10.43 cells x10^9/L
Standard Error 0.87
|
9.97 cells x10^9/L
Standard Error 0.66
|
|
Leucocytes
Day 14
|
9.32 cells x10^9/L
Standard Error 1.08
|
9.40 cells x10^9/L
Standard Error 0.82
|
|
Leucocytes
Day 21
|
6.47 cells x10^9/L
Standard Error 0.61
|
6.20 cells x10^9/L
Standard Error 0.45
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21Neutrophils count a patient's blood.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Neutrophils
At inclusion
|
6.11 cells x10^9/L
Standard Error 0.86
|
5.50 cells x10^9/L
Standard Error 0.48
|
|
Neutrophils
Day 3
|
6.27 cells x10^9/L
Standard Error 0.85
|
6.37 cells x10^9/L
Standard Error 0.61
|
|
Neutrophils
Day 7
|
7.60 cells x10^9/L
Standard Error 0.78
|
6.75 cells x10^9/L
Standard Error 0.68
|
|
Neutrophils
Day 14
|
6.53 cells x10^9/L
Standard Error 1.16
|
6.58 cells x10^9/L
Standard Error 0.83
|
|
Neutrophils
Day 21
|
4.17 cells x10^9/L
Standard Error 0.59
|
3.74 cells x10^9/L
Standard Error 0.40
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21lymphocyte count a patient's blood.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Absolute Lymphocytes
At inclusion
|
1.165 cells x10^9/L
Standard Error 0.11
|
1.44 cells x10^9/L
Standard Error 0.15
|
|
Absolute Lymphocytes
Day 3
|
1.32 cells x10^9/L
Standard Error 0.17
|
1.36 cells x10^9/L
Standard Error 0.10
|
|
Absolute Lymphocytes
Day 7
|
1.94 cells x10^9/L
Standard Error 0.26
|
2.07 cells x10^9/L
Standard Error 0.16
|
|
Absolute Lymphocytes
Day 14
|
2.02 cells x10^9/L
Standard Error 0.21
|
2.14 cells x10^9/L
Standard Error 0.15
|
|
Absolute Lymphocytes
Day 21
|
1.63 cells x10^9/L
Standard Error 0.18
|
1.88 cells x10^9/L
Standard Error 0.12
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the number of seconds it takes for a clot to form in a patient's blood.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Activated Partial Thromboplastin Time
At inclusion
|
29.62 seconds
Standard Error 1.43
|
30.62 seconds
Standard Error 0.70
|
|
Activated Partial Thromboplastin Time
Day 3
|
27.96 seconds
Standard Error 0.64
|
29.62 seconds
Standard Error 0.76
|
|
Activated Partial Thromboplastin Time
Day 7
|
27.49 seconds
Standard Error 0.62
|
28.72 seconds
Standard Error 0.73
|
|
Activated Partial Thromboplastin Time
Day 14
|
28.29 seconds
Standard Error 0.88
|
29.37 seconds
Standard Error 0.67
|
|
Activated Partial Thromboplastin Time
Day 21
|
31.39 seconds
Standard Error 2.03
|
31.12 seconds
Standard Error 0.73
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Fibrinogen Level
At inclusion
|
713.13 mg/dL
Standard Error 44.64
|
732.36 mg/dL
Standard Error 32.57
|
|
Fibrinogen Level
Day 3
|
671.94 mg/dL
Standard Error 42.38
|
683.43 mg/dL
Standard Error 33.11
|
|
Fibrinogen Level
Day 7
|
591.44 mg/dL
Standard Error 36.40
|
559.77 mg/dL
Standard Error 32.01
|
|
Fibrinogen Level
Day 14
|
562.67 mg/dL
Standard Error 38.92
|
531.46 mg/dL
Standard Error 35.71
|
|
Fibrinogen Level
Day 21
|
527.23 mg/dL
Standard Error 39.46
|
511.96 mg/dL
Standard Error 33.35
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Fragment D-dimer Assessment
At inclusion
|
350.26 ng/mL
Standard Error 62.80
|
294.11 ng/mL
Standard Error 36.63
|
|
Fragment D-dimer Assessment
Day 3
|
443.2 ng/mL
Standard Error 77.12
|
377.52 ng/mL
Standard Error 117.12
|
|
Fragment D-dimer Assessment
Day 7
|
321.63 ng/mL
Standard Error 61.81
|
377.03 ng/mL
Standard Error 91.58
|
|
Fragment D-dimer Assessment
Day 14
|
300.69 ng/mL
Standard Error 51.74
|
222.8 ng/mL
Standard Error 24.66
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Glomerular Filtration Rate Assessment
At inclusion
|
80.44 ml/min
Standard Error 5.41
|
93.65 ml/min
Standard Error 3.31
|
|
Glomerular Filtration Rate Assessment
Day 3
|
86.15 ml/min
Standard Error 4.07
|
96.68 ml/min
Standard Error 3.35
|
|
Glomerular Filtration Rate Assessment
Day 7
|
87.04 ml/min
Standard Error 4.60
|
96.81 ml/min
Standard Error 3.55
|
|
Glomerular Filtration Rate Assessment
Day 14
|
80.17 ml/min
Standard Error 5.29
|
92.24 ml/min
Standard Error 3.35
|
|
Glomerular Filtration Rate Assessment
Day 21
|
83.98 ml/min
Standard Error 4.59
|
92.53 ml/min
Standard Error 3.71
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Troponin I Assessment
At inclusion
|
6.55 ng/mL
Standard Error 1.59
|
5.45 ng/mL
Standard Error 0.65
|
|
Troponin I Assessment
Day 3
|
5.86 ng/mL
Standard Error 1.57
|
6.41 ng/mL
Standard Error 0.78
|
|
Troponin I Assessment
Day 7
|
5.50 ng/mL
Standard Error 1.56
|
6.14 ng/mL
Standard Error 1.10
|
|
Troponin I Assessment
Day 14
|
5.24 ng/mL
Standard Error 1.80
|
4.32 ng/mL
Standard Error 0.57
|
|
Troponin I Assessment
Day 21
|
5.44 ng/mL
Standard Error 1.27
|
4.24 ng/mL
Standard Error 0.56
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Procalcitonin Assessment
At inclusion
|
0.86 ng/L
Standard Error 0.73
|
0.11 ng/L
Standard Error 0.02
|
|
Procalcitonin Assessment
Day 3
|
0.78 ng/L
Standard Error 0.70
|
0.09 ng/L
Standard Error 0.02
|
|
Procalcitonin Assessment
Day 7
|
0.44 ng/L
Standard Error 0.39
|
0.05 ng/L
Standard Error 0.01
|
|
Procalcitonin Assessment
Day 14
|
0.04 ng/L
Standard Error 0.005
|
0.04 ng/L
Standard Error 0.004
|
|
Procalcitonin Assessment
Day 21
|
0.05 ng/L
Standard Error 0.01
|
0.04 ng/L
Standard Error 0.01
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
C-reactive Protein Assessment
At inclusion
|
64.19 mg/dL
Standard Error 15.81
|
55.39 mg/dL
Standard Error 9.20
|
|
C-reactive Protein Assessment
Day 3
|
52.25 mg/dL
Standard Error 12.77
|
43.51 mg/dL
Standard Error 8.67
|
|
C-reactive Protein Assessment
Day 7
|
33.83 mg/dL
Standard Error 11.42
|
16.60 mg/dL
Standard Error 3.55
|
|
C-reactive Protein Assessment
Day 14
|
18.49 mg/dL
Standard Error 4.85
|
9.18 mg/dL
Standard Error 1.97
|
|
C-reactive Protein Assessment
Day 21
|
17.46 mg/dL
Standard Error 5.35
|
8.72 mg/dL
Standard Error 1.72
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Lactate Dehydrogenase (LDH) Assessment
At inclusion
|
283.56 Unit/L
Standard Error 12.78
|
306.31 Unit/L
Standard Error 21.80
|
|
Lactate Dehydrogenase (LDH) Assessment
Day 3
|
286.47 Unit/L
Standard Error 15.27
|
317.18 Unit/L
Standard Error 25.14
|
|
Lactate Dehydrogenase (LDH) Assessment
Day 7
|
276.67 Unit/L
Standard Error 17.50
|
267.6 Unit/L
Standard Error 16.95
|
|
Lactate Dehydrogenase (LDH) Assessment
Day 14
|
277 Unit/L
Standard Error 27.41
|
232.25 Unit/L
Standard Error 9.21
|
|
Lactate Dehydrogenase (LDH) Assessment
Day 21
|
246.38 Unit/L
Standard Error 21.33
|
215.04 Unit/L
Standard Error 8.10
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Interleukin-6 Assessment
At inclusion
|
29.48 pg/mL
Standard Error 6.01
|
32.60 pg/mL
Standard Error 5.21
|
|
Interleukin-6 Assessment
Day 3
|
28.18 pg/mL
Standard Error 4.10
|
25.37 pg/mL
Standard Error 5.83
|
|
Interleukin-6 Assessment
Day 7
|
17.33 pg/mL
Standard Error 3.54
|
12.24 pg/mL
Standard Error 3.12
|
|
Interleukin-6 Assessment
Day 14
|
11.31 pg/mL
Standard Error 3.45
|
12.02 pg/mL
Standard Error 2.53
|
|
Interleukin-6 Assessment
Day 21
|
10.76 pg/mL
Standard Error 2.68
|
11.80 pg/mL
Standard Error 3.31
|
SECONDARY outcome
Timeframe: At inclusion, Day 3, Day 7, Day 14, Day 21measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Ferritin Blood Assessment
Day 3
|
626.24 ng/mL
Standard Deviation 136.86
|
736.80 ng/mL
Standard Deviation 119.52
|
|
Ferritin Blood Assessment
At inclusion
|
566.48 ng/mL
Standard Deviation 158.23
|
745.60 ng/mL
Standard Deviation 129.99
|
|
Ferritin Blood Assessment
Day 7
|
624.35 ng/mL
Standard Deviation 124.99
|
670.25 ng/mL
Standard Deviation 92.21
|
|
Ferritin Blood Assessment
Day 14
|
412.88 ng/mL
Standard Deviation 78.48
|
450.42 ng/mL
Standard Deviation 60.09
|
|
Ferritin Blood Assessment
Day 21
|
392.57 ng/mL
Standard Deviation 123.70
|
272.27 ng/mL
Standard Deviation 48.16
|
SECONDARY outcome
Timeframe: Day 21Percentage of patients requiring admission to intensive care units.
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Percentage of Patients Requiring Admission to Intensive Care Units.
yes
|
16 percentage of participants
|
17 percentage of participants
|
|
Percentage of Patients Requiring Admission to Intensive Care Units.
No
|
84 percentage of participants
|
83 percentage of participants
|
SECONDARY outcome
Timeframe: Day 15number of dead participants through day 15
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Mortality Rate at 15 Days
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30number of dead participants through day 30
Outcome measures
| Measure |
Control Group
n=17 Participants
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 Participants
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Mortality Rate at 30 Days
|
0 Participants
|
0 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=17 participants at risk
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
|
Intervention Group
n=37 participants at risk
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash (Grade 1)
|
0.00%
0/17 • 21 days
\[Not Specified\]
|
2.7%
1/37 • 21 days
\[Not Specified\]
|
|
Ear and labyrinth disorders
Left ear hearing los
|
0.00%
0/17 • 21 days
\[Not Specified\]
|
2.7%
1/37 • 21 days
\[Not Specified\]
|
|
Nervous system disorders
Mild dizziness
|
0.00%
0/17 • 21 days
\[Not Specified\]
|
2.7%
1/37 • 21 days
\[Not Specified\]
|
|
General disorders
Left hypochondrium pain
|
0.00%
0/17 • 21 days
\[Not Specified\]
|
2.7%
1/37 • 21 days
\[Not Specified\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place