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

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of the Philippines

Criteria

Inclusion Criteria:

• Patient must be 19 years of age or older

• Hospitalized with COVID-19 and confirmed via SARS-CoV-2 RT-PCR testing

• Patient is willing and able to provide written consent and comply with all protocol requirements

• Patient agrees to storage of specimens for future testing

Exclusion Criteria:

• Female subjects with positive pregnancy test, are breastfeeding or planning to become pregnant/breastfeed during the study period

• Symptomatic illness exceeding 14 days from onset of illness at time of enrollment

• ICU admission on initial presentation at the hospital (includes patients with clinical indications for ICU admission as follows:

1. Respiratory distress with requirement of O2 >6 lpm to maintain O2 sat >92%

2. Rapid escalation of O2 requirement/significant work of breathing

3. Hemodynamic instability: SBP <90, MAP <65

• Receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (IVIg) in the past 30 days prior to enrolment

• Known IgA deficiency

• Presence of any contraindication to transfusion (or history of prior severe reactions to transfusion of blood products)