Status:
COMPLETED
Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients
Lead Sponsor:
Priscilla Hsue, MD
Collaborating Sponsors:
Vitalant Research Institute
San Francisco General Hospital
Conditions:
COVID-19
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sympto...
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 d...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Enrollment:
- Patients ≥18 years of age
- Hospitalized with COVID-19
- Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
- Pulmonary infiltrates on chest imaging
- Oxygenation of \<95% on room air
- Laboratory confirmed COVID-19
- Exclusion Criteria
- Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
- Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
- Currently experiencing severe hypoxemic failure, as defined in study endpoints
- Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
- 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
Exclusion
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04421404
Start Date
June 9 2020
End Date
April 30 2021
Last Update
October 7 2022
Active Locations (3)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110
2
UCSF Medical Center at Mount Zion
San Francisco, California, United States, 94115
3
University of California, San Francisco Medical Center (Parnassus Campus)
San Francisco, California, United States, 94143