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 supplementation.
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 placebo control, Lactated Ringer's Solution (LR) or saline solution (SS).
Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7
days from the onset of illness OR within 3 days of hospitalization will be eligible to
participate.
Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
Other: Saline solution
Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Inclusion Criteria
1. Patients ≥18 years of age
2. Hospitalized with laboratory confirmed COVID-19
3. One or more of the following respiratory signs or symptoms: cough, chest pain,
shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
6. 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
1. Receipt of pooled immunoglobulin in past 30 days
2. Contraindication to transfusion or history of prior reactions to transfusion blood
products
3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
4. Volume overload secondary to congestive heart failure or renal failure
5. Unlikely to survive past 72 hours from screening based on the assessment of the
investigator
6. Unlikely to be able to assess and follow outcome due to poor functional status
Yale University School of Medicine
New Haven, Connecticut, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Montefiore Medical Center
Bronx, New York, United States
NYU Langone Health
New York, New York, United States
University of Texas Rio Grande Valley
Edinburg, Texas, United States
The University of Texas Health Science Center
Houston, Texas, United States
The University of Texas Health Science Center
Tyler, Texas, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin / Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Mila B Ortigoza, MD, PhD, Principal Investigator
NYU Langone Health