Status:
COMPLETED
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Albert Einstein College of Medicine
Conditions:
COVID-19
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen su...
Detailed Description
A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a plac...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients ≥18 years of age
- Hospitalized with laboratory confirmed COVID-19
- One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
- Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
- On supplemental oxygen, non-invasive ventilation or high-flow oxygen
- Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
- Exclusion Criteria
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
- Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Volume overload secondary to congestive heart failure or renal failure
- Unlikely to survive past 72 hours from screening based on the assessment of the investigator
- Unlikely to be able to assess and follow outcome due to poor functional status
Exclusion
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
941 Patients enrolled
Trial Details
Trial ID
NCT04364737
Start Date
April 17 2020
End Date
December 12 2022
Last Update
January 26 2023
Active Locations (9)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
2
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
3
NYU Langone Health
New York, New York, United States, 10003
4
Montefiore Medical Center
The Bronx, New York, United States, 10467