Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

Phase 2

Completed

• Conditions: COVID-19; Sars-CoV2
• Interventions: Biological: COVID-19 Convalescent Plasma (CCP); Biological: Placebo

• Registration Number: NCT04421404
• Lead Sponsor: Priscilla Hsue, MD

Brief Summary

The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

Detailed Description

A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-05
• Study Start: 2020-06-09
• Study First Posted: 2020-06-09
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Results First Submitted: 2021-05-18
• Results First Submitted QC: 2021-08-23
• Results First Posted: 2021-08-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID-19 Convalescent Plasma	COVID-19 Convalescent Plasma (CCP)	Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo	Placebo	Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.

Primary Outcome Measures

Name	Time	Method
Mechanical Ventilation or Death Endpoint	Day 14	Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.

Secondary Outcome Measures

Name	Time	Method
Mechanical Ventilation or Death Endpoint	Day 28	Progression to mechanical ventilation or death within the first 28 days of enrollment.
8-Point Ordinal Scale Endpoint	Day 29	Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale.; 8 Point WHO Ordinal Scale of Clinical Status: Uninfected (No clinical or virological evidence of infection) - 0; Ambulatory (No limitation of activities) - 1 Ambulatory (Limitation of Activities) - 2; Hospitalized Mild Disease (Hospitalized, no oxygen therapy) - 3 Hospitalized Mild Disease (Oxygen by mask or nasal prongs) - 4; Hospitalized Severe Disease (Non-invasive ventilation or high flow oxygen) - 5 Hospitalized Severe Disease (Intubation and mechanical ventilation) - 6 Hospitalized Severe Disease (Ventilation + Additional organ support (pressors, RRT, ECMO)) - 7; Dead (Death) - 8

Trial Locations

Locations (3)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

UCSF Medical Center at Mount Zion; 🇺🇸 San Francisco, California, United States

University of California, San Francisco Medical Center (Parnassus Campus); 🇺🇸 San Francisco, California, United States