Efficacy and Safety of COVID-19 Convalescent Plasma

Study Overview
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Brief Summary
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Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

Detailed Description
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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.

Official Title
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Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety

Conditions
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SARS-CoV 2, COVID-19, Convalescent Plasma

Intervention / Treatment
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* Biological: anti-SARS-CoV-2 convalescent plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hospitalized patients with SARS CoV-2 infection<br>Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma | Biological: anti-SARS-CoV-2 convalescent plasma<br>* Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of oxygenation and ventilation support | The total number of days patients required respiratory support. | 28 days after transfusion or until hospital discharge (whichever comes first) | 
| Hospital length of stay (LOS) | Total number of days patients were admitted to the hospital. | 28 days after transfusion or until hospital discharge (whichever comes first) | 
| ICU admission | Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion. | 28 days after transfusion or until hospital discharge (whichever comes first) | 
| Ventilator free days | Days without oxygenation support after receiving convalescent plasma | 28 days after transfusion or until hospital discharge (whichever comes first) | 
| Incidence of serious adverse events | Cumulation incidence of serious adverse events during the study protocol | 28 days after transfusion or until hospital discharge (whichever comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of respiratory support | Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) | 28 days after transfusion or until hospital discharge (whichever comes first) | 
| Number of participants with different clinical outcomes including death, critical illness and recovery | Number of participants with different clinical outcomes including death, critical illness and recovery | 28 days after transfusion or until hospital discharge (whichever comes first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, anti SARS-CoV-2 convalescent plasma, COVID-19 convalescent plasma