Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

Completed · Phase 1

Conditions studied: Covid19

In brief

This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.

Key facts

Study ID

NCT04554992

Run by

The Methodist Hospital Research Institute

People needed

350

Starts

2020-03-20

Expected to finish

2023-12-20

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)

You may not qualify if…

• History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module [see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf].
• Has underlying uncompensated and untreatable end stage disease.
• Fluid overload or other condition that would contraindicate administration of plasma

Where it is running

• Houston Methodist Hopsital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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