Convalescent Plasma for Patients With COVID-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-04

Study Completion Date

2020-08-01

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.

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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.

Conditions

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Coronavirus Infection Coronavirus COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent Plasma Intervention

Convalescent plasma 200mL transfusion

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

One 200mL transfusion of ABO compatible convalescent plasma over 3 hours

Standard Therapy Control

Standard therapy for COVID-19 disease as defined by institutional protocols

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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