Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Study Overview
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Brief Summary
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Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

Official Title
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Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial

Conditions
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Severe Acute Respiratory Syndrome Coronavirus 2

Intervention / Treatment
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* Biological: COVID-19 convalescent plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 18 years CALL score ≥ 9 (progression risk score) PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact) Any symptoms of COVID-19 infection Admission due to COVID-19 infection Signed informed consent ECOG before COVID-19 infection 0-2 Exclusion Criteria: PaFi <200 or mechanical ventilation indication Clinically relevant co-infection at admission Pregnancy or lactation IgA deficiency or IgA nephropathy Immunoglobulin or plasma administration in the last 60 days Contraindication to transfusion or previous allergy to blood-derived products Do-not-resuscitate status Patients receiving other investigational drug for COVID-19 in a clinical trial Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early COVID-19 convalescent plasma<br>COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility | Biological: COVID-19 convalescent plasma<br>* COVID-19 convalescent plasma<br>|
| Experimental: COVID-19 convalescent plasma<br>COVID-19 convalescent plasma 200 ml day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for >7 days after enrolment | Biological: COVID-19 convalescent plasma<br>* COVID-19 convalescent plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization |  | 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median duration of fever | Days | 1 year | 
| Median duration of mechanical ventilation | Days | 1 year follow up | 
| Median length of ICU stay | Days | 1 year follow up | 
| Median length of admission | Days | 1 year follow up | 
| Hospital mortality rate (percentage) |  | 1 year follow up | 
| 30-day mortality (percentage) |  | 1 year follow up | 
| Readmission rate (percentage) |  | 1 year follow up | 
| Median length of viral clearance | days | 1 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma, COVID-19, severe acute respiratory syndrome coronavirus 2