Convalescent Plasma for Patients With COVID-19

Phase 2

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma Intervention	Convalescent plasma	Convalescent plasma 200mL transfusion

Primary Outcome Measures

Name	Time	Method
Change in Respiratory Disease Severity	day 3 post transfusion	Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion

Secondary Outcome Measures

Name	Time	Method
Normal Chest X Ray at 28 Days	28 days	Change in Chest X Ray Findings
All-cause Mortality	28 days	All-cause overall deaths at end of trial at 28 days
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.	Total ICU length of stay
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.	Hospital length of stay
Ventilator Days	28 day	Duration of time on ventilator
Number of Participants With Transfusion Adverse Events	From transfusion up to 1 day post-transfusion	Adverse transfusion events after 1 unit of convalescent plasma