Trial Outcomes & Findings for Efficacy and Safety of COVID-19 Convalescent Plasma (NCT NCT04397523)
NCT ID: NCT04397523
Last Updated: 2024-05-28
Results Overview
The total number of days patients required respiratory support.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
28 days after transfusion or until hospital discharge (whichever comes first)
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
189
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Transfer from/to other hospital
|
8
|
Baseline Characteristics
Efficacy and Safety of COVID-19 Convalescent Plasma
Baseline characteristics by cohort
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Age, Customized
18-35 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
36-45 years
|
23 Participants
n=5 Participants
|
|
Age, Customized
46-55 years
|
47 Participants
n=5 Participants
|
|
Age, Customized
56-65 years
|
56 Participants
n=5 Participants
|
|
Age, Customized
66-75 years
|
41 Participants
n=5 Participants
|
|
Age, Customized
more than 75 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Macedonians
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Albanians
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · others
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
North Macedonia
|
189 Participants
n=5 Participants
|
|
Body Mass Index
18.5-24.9 kg/m^2 (normal)
|
37 Participants
n=5 Participants
|
|
Body Mass Index
25-29.9 kg/m^2 (overweight)
|
95 Participants
n=5 Participants
|
|
Body Mass Index
equal or more than 30 kg/m^2 (obese)
|
57 Participants
n=5 Participants
|
|
ABO blood type
A
|
94 Participants
n=5 Participants
|
|
ABO blood type
B
|
32 Participants
n=5 Participants
|
|
ABO blood type
O
|
47 Participants
n=5 Participants
|
|
ABO blood type
AB
|
16 Participants
n=5 Participants
|
|
WHO progression score
WHO disease progression score 3 - hospitalized patients without oxygen support
|
65 Participants
n=5 Participants
|
|
WHO progression score
WHO progression score 4 - hospitalized patients with oxygen support (nasal canila, oxygen mask)
|
65 Participants
n=5 Participants
|
|
WHO progression score
WHO progression score 5 - hospitalized with high-flow oxygen support (noninvasive ventilation)
|
59 Participants
n=5 Participants
|
|
Comorbidities
yes
|
134 Participants
n=5 Participants
|
|
Comorbidities
no
|
55 Participants
n=5 Participants
|
|
Body Mass Index
|
28.4 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Population: This is the number of patients that required respiratory support before CCP transfusion
The total number of days patients required respiratory support.
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=124 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Duration of Oxygenation Support
|
7.4 days
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Population: The bellow are shown subgroups of participants according to the WHO disease progression scores 3,4 and 5, which all together comprises total investigated group of 189 participants.
Total number of days patients were admitted to the hospital after convalescent plasma transfusion.
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Hospital Length of Stay (LOS)
total investigated group
|
11.0 days
Standard Deviation 5.3
|
|
Hospital Length of Stay (LOS)
patients with WHO disease progression score 3, which are not on oxygen support
|
8.6 days
Standard Deviation 2.7
|
|
Hospital Length of Stay (LOS)
patients with WHO score 4, which are on oxygen support with nasal canila or oxygen mask
|
11.1 days
Standard Deviation 4.7
|
|
Hospital Length of Stay (LOS)
patients with WHO score 5, which are on oxygen support with noninvasive ventilation
|
13.6 days
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
ICU Admission
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Number of participants without oxygenation support after receiving convalescent plasma
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Number of Participants With Oxygenation Free Days
Participants with oxygenation free days 24 hours after CCP transfusion
|
76 Participants
|
|
Number of Participants With Oxygenation Free Days
Participants with oxygenation free days before CCP transfusion
|
65 Participants
|
|
Number of Participants With Oxygenation Free Days
Participants with oxygenation free days after 7 days after transfusion
|
103 Participants
|
|
Number of Participants With Oxygenation Free Days
Participants with oxygenation free days at discharge
|
167 Participants
|
PRIMARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Number of participants with serious adverse events during the study protocol
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Type of Respiratory Support
Nasal canula, oxygen mask before CCP transfusion
|
65 Participants
|
|
Type of Respiratory Support
Nasal canula, oxygen mask 24 hours after CCP transfusion
|
56 Participants
|
|
Type of Respiratory Support
Nasal canula, oxygen mask 7 days after CCP transfusion
|
35 Participants
|
|
Type of Respiratory Support
Noninvasive ventilation, high flow nasal canula before CCP transfusion
|
59 Participants
|
|
Type of Respiratory Support
Noninvasive ventilation, high flow nasal canula 24 hours after CCP transfusion
|
56 Participants
|
|
Type of Respiratory Support
Noninvasive ventilation, high flow nasal canula 7 days after CCP transfusion
|
25 Participants
|
|
Type of Respiratory Support
Intubation or invasive mechanical ventilation, before CCP transfusion
|
0 Participants
|
|
Type of Respiratory Support
Intubation or invasive mechanical ventilation, 24 hours after CCP transfusion
|
1 Participants
|
|
Type of Respiratory Support
Intubation or invasive mechanical ventilation, 7 days after CCP transfusion
|
1 Participants
|
|
Type of Respiratory Support
Rescue ventilation before CCP transfusion
|
0 Participants
|
|
Type of Respiratory Support
Rescue ventilation 24 hours after CCP transfusion
|
0 Participants
|
|
Type of Respiratory Support
Rescue ventilation 7 days after CCP transfusion
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 days after transfusion or until hospital discharge (whichever comes first)Number of participants with different clinical outcomes including death, critical illness, limitation of activities and recovery
Outcome measures
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 Participants
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery
total recovery
|
164 Participants
|
|
Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery
recovery with limitation of activities
|
3 Participants
|
|
Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery
death
|
22 Participants
|
Adverse Events
Hospitalized Patients With SARS CoV-2 Infection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 22 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hospitalized Patients With SARS CoV-2 Infection
n=189 participants at risk
Hospitalized adult patients with confirmed SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
|
|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.53%
1/189 • Number of events 1 • During hospitalization, after receiving convalescent plasma
|
Additional Information
Assoc. Prof. Dr. Rada M. Grubovic Rastvorceva, MD MSci PhD, CMO
Institute for Transfusion Medicine of RNM
Phone: +38923226923
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place