Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Convalescent Plasma
- Sponsor
- Institute for Transfusion Medicine of RNM
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of Participants With Oxygenation Free Days
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Number of Participants With Oxygenation Free Days
Time Frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants without oxygenation support after receiving convalescent plasma
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.
Number of Participants With Serious Adverse Events
Time Frame: 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
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 after convalescent plasma transfusion.
Secondary Outcomes
- Type of Respiratory Support(28 days after transfusion or until hospital discharge (whichever comes first))
- Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery(28 days after transfusion or until hospital discharge (whichever comes first))