Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Priscilla Hsue, MDAnnie Leutkemeyer
Photo of Priscilla Hsue
Priscilla Hsue

Description

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.

Official Title

A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients

Details

A total of 30 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.

Keywords

COVID-19 Sars-CoV2 Convalescent plasma Coronavirus Infections COVID-19 Convalescent Plasma (CCP) COVID-19 Convalescent Plasma

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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 that do not yet have data to support efficacy, such as hydroxychloroquine, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir 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

Locations

  • San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • UCSF Medical Center at Mount Zion accepting new patients
    San Francisco California 94115 United States
  • University of California, San Francisco Medical Center (Parnassus Campus) accepting new patients
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Priscilla Hsue, MD
    Professional Experience: Dr. Hsue trained in Internal Medicine in the Molecular Medicine Training Program at UC San Francisco and in Cardiovascular Medicine at UC San Francisco. She served as Chief Cardiology Fellow during this time. She has been on the faculty in the Department of Medicine at San Francisco General Hospital since 2002.
  • Annie Leutkemeyer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Priscilla Hsue, MD
ID
NCT04421404
Phase
Phase 2
Study Type
Interventional
Last Updated