Efficacy and Safety of COVID-19 Convalescent Plasma
- Conditions
- SARS-CoV 2Convalescent PlasmaCOVID-19
- Interventions
- Biological: anti-SARS-CoV-2 convalescent plasma
- Registration Number
- NCT04397523
- Lead Sponsor
- Institute for Transfusion Medicine of RNM
- Brief Summary
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
- Detailed Description
There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hospitalized patients with SARS CoV-2 infection anti-SARS-CoV-2 convalescent plasma Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
- Primary Outcome Measures
Name Time Method Number of Participants With Oxygenation Free Days 28 days after transfusion or until hospital discharge (whichever comes first) Number of participants without oxygenation support after receiving convalescent plasma
ICU Admission 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.
Number of Participants With Serious Adverse Events 28 days after transfusion or until hospital discharge (whichever comes first) Number of participants with serious adverse events during the study protocol
Duration of Oxygenation Support 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) 28 days after transfusion or until hospital discharge (whichever comes first) Total number of days patients were admitted to the hospital after convalescent plasma transfusion.
- Secondary Outcome Measures
Name Time Method Type of Respiratory Support 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 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
Trial Locations
- Locations (1)
Institute for Transfusion Medicine of RNM
🇲🇰Skopje, North Macedonia