NCT04567173

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

A Randomized, Open-Label, Single Center Clinical Trial to Assess the Efficacy and Safety of Convalescent Plasma to Hospitalized Adult COVID-19 Patients as Adjunctive Therapy to Reduce the Need for ICU Admission: Co-CLARITY Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of the Philippines · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 3, randomized, non-placebo controlled, open-label, single-center clinical trial which will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma given from the 3rd to 14th day of illness after the onset of symptoms in preventing ICU admission among hospitalized COVID-19 patients compared to standard of care. Consecutive patients with COVID-19 admitted to the UP Philippine General Hospital will be offered participation into the study. Patients in the intervention group will receive one dose of type-specific anti-SARS-CoV-2 convalescent plasma (500 mL collected by whole blood donation or standard pheresis at the UP-PGH blood bank from a volunteer who recovered from COVID-19). The primary safety endpoints include serious adverse events judged to be related to convalescent plasma. The study also aims to compare anti-SARS-CoV-2 antibody titers and rates, levels, and duration of SARS-CoV-2 RNA in nasopharyngeal swabs using RT-PCR between the intervention and control groups.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Anti-SARS-CoV-2 convalescent plasma	convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19

Timeline

• Start date: 2020-09-21
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-09-28
• Last updated: 2022-05-24

Locations

1 site across 1 country: Philippines