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.
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.
Biological: COVID-19 Convalescent Plasma (CCP)
COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
Biological: Placebo
Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
Inclusion Criteria for Enrollment:
1. Patients ≥18 years of age
2. Hospitalized with COVID-19
3. Enrolled within 72 hours of hospitalization OR within day 14 from first signs of
illness
4. Pulmonary infiltrates on chest imaging
5. Oxygenation of <95% on room air
6. Laboratory confirmed COVID-19
Exclusion Criteria
1. Contraindication to transfusion due to inability to tolerate additional fluid, such as
due to decompensated congestive heart failure
2. Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of
positive pressure therapy for sleep disordered breathing
3. Currently experiencing severe hypoxemic failure, as defined in study endpoints
4. Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
5. Not currently enrolled another interventional clinical trial of COVID-19 treatment.
Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19
treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these
medications must be stopped prior to enrollment. Receipt of current standard of care
COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be
recorded as a concomitant medication.
Note: Pregnancy is not exclusionary but will merit additional discussion of risks &
benefits in the context of ongoing pregnancy
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