drugset / Trial / NCT04567173

Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19

NCT04567173 ↗

Phase 2/3 Terminated 44 enrolled University of the Philippines
RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.

Timeline

Start
2020-09-21
Primary completion
2021-06-30
Completion
2021-06-30

Outcome

Outcome not reported

Stopped: “Limited enrolment (unable to achieve target sample size)”

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-SARS-CoV-2 convalescent plasma Protein / enzyme biologic 500 ml Intravenous

Indications