Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).

Detailed Description
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This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients. After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.

Official Title
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A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: anti-SARS-CoV-2 plasma
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age Hospitalized with COVID-19-related acute respiratory symptoms Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3 (Hospitalized, no oxygen therapy) or 4 (Hospitalized, on oxygen by mask or nasal prongs) Laboratory-confirmed COVID-19 First signs of infection occurring no more than 14 days prior to enrollment Exclusion Criteria: Receipt of pooled immunoglobulin in the past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products Admission to intensive care unit at any point during hospital course prior to enrollment

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-SARS-CoV-2 plasma<br>Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma | Drug: anti-SARS-CoV-2 plasma<br>* Administration of anti-SARS-CoV-2 convalescent plasma<br>* Other names: Convalescent Plasma;|
| Placebo Comparator: Placebo<br>Patients receive one dose (250-300ml) of placebo (albumin 5%) | Other: Placebo<br>* Administration of placebo (albumin 5%)<br>* Other names: Albumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression measured by WHO scale | Disease progression from the state at randomization (with a 3 or 4 on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is 6 or greater on the WHO scale) during the study period | Day 0 through Day 28 (or hospital discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of maximum WHO score per group | Comparison of the number of participants reaching a maximum daily WHO score of 5, 7, and 8 during the study period per group | Day 0 through Day 28 (or hospital discharge) | 
| Comparison of decrease of median and maximum WHO score per group | Comparison of the median and maximum daily WHO scores during the study period per group | Day 0 through Day 28 (or hospital discharge) | 
| Comparison of time to clinical improvement per group | Comparison of time to clinical improvement, defined as time between randomization and time to improvement (WHO Ordinal Scale 2 first reached for at least 1 day) | Day 0 through Day 28 (or hospital discharge) | 
| Comparison of time to reach score of 6 or greater on the WHO scale | Evaluate the time to reach score of at least 6 within 28 days | Day 0 through Day 28 (or hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-SARS-CoV-2 plasma