Convalescent Plasma for Patients With COVID-19

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385199
• Other study ID #: 13807
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• COVID
• COVID-19

Intervention

Biological:
• Convalescent plasma
One 200mL transfusion of ABO compatible convalescent plasma over 3 hours

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Respiratory Disease Severity	Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion	day 3 post transfusion
Secondary	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.
Secondary	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.
Secondary	Ventilator Days	Duration of time on ventilator	28 day
Secondary	Number of Participants With Transfusion Adverse Events	Adverse transfusion events after 1 unit of convalescent plasma	From transfusion up to 1 day post-transfusion
Secondary	Normal Chest X Ray at 28 Days	Change in Chest X Ray Findings	28 days
Secondary	All-cause Mortality	All-cause overall deaths at end of trial at 28 days	28 days