CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
- Study HIC#:2000028181
- Last Updated:09/08/2020
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.
- Age18 years and older
- Start Date08/30/2020
- End Date01/30/2023
Trial Purpose and Description
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.
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.
- 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.
- 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