drugset / Trial / NCT04353206

Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure

NCT04353206

Phase 0 Terminated 6 enrolled Noah Merin Johns Hopkins University · collab
NaSingle-groupOpen-labelTreatment

Summary

This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use. Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose. The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

Timeline

Start
2020-06-27
Primary completion
2020-11-01
Completion
2020-11-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Convalescent Plasma Protein / enzyme biologic Other

Indications