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

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: Anti-SARS-CoV-2 convalescent plasma

• Registration Number: NCT04567173
• Lead Sponsor: University of the Philippines

Brief 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.

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-28
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-SARS-CoV-2 convalescent plasma	Anti-SARS-CoV-2 convalescent plasma	About 500 mL of type-specific anti-SARS-CoV-2 convalescent plasma collected by whole blood donation or standard pheresis from a volunteer who recovered from COVID-19 transfused intravenously as 2 aliquots of 250 mL

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events	28 days from enrollment	Cumulative incidence of serious adverse events (transfusion-related acute lung injury, transfusion associated circulatory overload, transfusion related infection and anaphylaxis/severe allergic reactions) during the study period

Secondary Outcome Measures

Name	Time	Method
Dialysis-free days	28 days from enrollment	Days without dialysis within 28 days from enrollment
Quick SOFA (qSOFA) score	28 days from enrollment	Quick Sequential Organ Failure Assessment (qSOFA) scores of study participants within 28 days from enrollment. The qSOFA score is a rapid bedside clinical score used to identify patients with suspected infection that are at a greater risk for a poor outcome. Minimum score is 0 and maximum score is 3. A higher score is associated with higher risk for in-hospital mortality.
Cardiopulmonary arrest	28 days from enrollment	Total number of patients experiencing cardiopulmonary arrest
Vasopressor-free days	28 days from enrollment	Days without vasopressors within 28 days from enrollment
ICU-free days	28 days from enrollment	Days without need for ICU admission within 28 days from enrollment
ICU mortality	28 days from enrollment	Total number of deaths among patients admitted to the ICU
ICU length of stay	28 days from enrollment	Total number of days patients were admitted to the ICU
Hospital mortality	28 days from enrollment	Total number of deaths among study participants
Hospital length of stay	28 days from enrollment	Total number of days patients were admitted to the hospital
28-day mortality	28 days from enrollment	Total number of patient deaths within 28 days from enrollment
Anti-SARS-CoV-2 antibody titers	days 0, 1, 7 and 14 of enrollment	Anti-SARS-CoV-2 IgG antibody titers
SARS-CoV-2 RNA by RT-PCR	days 0, 1, 7 and 14 of enrollment	Levels of SARS-CoV-2 RNA in nasopharyngeal swabs (or other specimen types as available) using RT-PCR

Trial Locations

Locations (1)

UP Philippine General Hospital; 🇵🇭 Manila, Philippines