Skip to main content
OpenTrials
Completed

NCT Number: NCT04385199

Convalescent Plasma for Patients With COVID-19

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Convalescent Plasma

Biological

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

Primary outcomes

  1. Change in Respiratory Disease Severity

    Time frame: day 3 post transfusion

    Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion

Secondary outcomes

  1. ICU Length of Stay

    Time frame: 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

  2. Length of Stay

    Time frame: 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

  3. Ventilator Days

    Time frame: 28 day

    Duration of time on ventilator

  4. Number of Participants With Transfusion Adverse Events

    Time frame: From transfusion up to 1 day post-transfusion

    Adverse transfusion events after 1 unit of convalescent plasma

  5. Normal Chest X Ray at 28 Days

    Time frame: 28 days

    Change in Chest X Ray Findings

  6. All-cause Mortality

    Time frame: 28 days

    All-cause overall deaths at end of trial at 28 days

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.