Efficacy and Safety of COVID-19 Convalescent Plasma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04397523 |
Recruitment Status :
Completed
First Posted : May 21, 2020
Last Update Posted : May 11, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Convalescent Plasma COVID-19 SARS-CoV 2 | Biological: anti-SARS-CoV-2 convalescent plasma | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety |
Actual Study Start Date : | April 30, 2020 |
Actual Primary Completion Date : | May 10, 2021 |
Actual Study Completion Date : | May 10, 2021 |

Arm | Intervention/treatment |
---|---|
Hospitalized patients with SARS CoV-2 infection
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
|
Biological: anti-SARS-CoV-2 convalescent plasma
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection |
- Duration of oxygenation and ventilation support [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]The total number of days patients required respiratory support.
- Hospital length of stay (LOS) [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]Total number of days patients were admitted to the hospital.
- ICU admission [ Time Frame: 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.
- Ventilator free days [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]Days without oxygenation support after receiving convalescent plasma
- Incidence of serious adverse events [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]Cumulation incidence of serious adverse events during the study protocol
- Type of respiratory support [ Time Frame: 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)
- Number of participants with different clinical outcomes including death, critical illness and recovery [ Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first) ]Number of participants with different clinical outcomes including death, critical illness and recovery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Blood donors:
- Age: >18 and <60 years
- Body weight : >55 kg
- Confirmed previous SARS CoV-2 infection
- Minimum 28 days after the last symptom or finishing of the isolation, or
- 21 day without symptoms from the date of the negative SARS CoV-2 test
- Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
- Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- Individuals who meet all regular voluntary donor eligibility requirements
Patients/recipients:
- Age: >18 years
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Patients with severe or immediately life-threatening COVID-19, or
- Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
- Informed consent provided by the patient or healthcare proxy
Exclusion Criteria:
Blood donors:
- Age : <18 or >60 years
- Female subjects who are pregnant
- HIV1,2 hepatitis B,C or syphilis infection
- Donors ineligible for regular voluntary blood donation
Patients/recipients:
- Age : <18 years
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- Patients who received in the past 30 days immunoglobulin therapy
- Females who are pregnant or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397523
North Macedonia | |
Institute for Transfusion Medicine of RNM | |
Skopje, North Macedonia, 1000 |
Principal Investigator: | Rada Grubovic Rastvorceva, MD MSci PhD | Institute for Transfusion Medicine of RNM | |
Principal Investigator: | Sedulla Useini, MD | Institute for Transfusion Medicine of RNM |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Institute for Transfusion Medicine of RNM |
ClinicalTrials.gov Identifier: | NCT04397523 |
Other Study ID Numbers: |
ITM05/2020MKD |
First Posted: | May 21, 2020 Key Record Dates |
Last Update Posted: | May 11, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 anti SARS-CoV-2 convalescent plasma COVID-19 convalescent plasma |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |