Convalescent Plasma for Patients With COVID-19

Study Overview
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Brief Summary
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Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.

Detailed Description
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Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear. Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia. Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate > 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio < 300 mm Hg; and bilateral airspace opacities on chest x-ray > 50% within 24 to 48 hours. Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids. Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.

Official Title
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The Use of Convalescent Plasma for Patients Hospitalized With COVID-19 Disease

Conditions
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COVID, Coronavirus Infection, Coronavirus

Intervention / Treatment
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* Biological: Convalescent plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours Exclusion Criteria: Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO

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
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent Plasma Intervention<br>Convalescent plasma 200mL transfusion | Biological: Convalescent plasma<br>* One 200mL transfusion of ABO compatible convalescent plasma over 3 hours<br>|
| No Intervention: Standard Therapy Control<br>Standard therapy for COVID-19 disease as defined by institutional protocols | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Respiratory Disease Severity | Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion | day 3 post transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of Stay | Total ICU length of stay | Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated. | 
| Length of Stay | Hospital length of stay | Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated. | 
| Ventilator Days | Duration of time on ventilator | 28 day | 
| Number of Participants With Transfusion Adverse Events | Adverse transfusion events after 1 unit of convalescent plasma | From transfusion up to 1 day post-transfusion | 
| Normal Chest X Ray at 28 Days | Change in Chest X Ray Findings | 28 days | 
| All-cause Mortality | All-cause overall deaths at end of trial at 28 days | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19