Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria: Admitted to the participating acute care facilities as listed above (Larkin Palm Springs Hospital, Larkin South Miami Hospital) AND enrolled in the trial within 48 hours of hospital admission (defined by when admission order was placed) AND Age ≥ 40 with at least one of the following comorbidities (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, pulmonary hypertension, idiopathic pulmonary fibrosis, asthma, COPD, cancer, HIV/AIDS, chronic kidney disease, immunosuppression, obesity). OR Age ≥ 65 years of age with or without comorbid conditions. AND Severe or life-threatening COVID-19 disease as defined by the FDA: "Severe disease is defined as one or more of the following: shortness of breath (dyspnea), respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, lung infiltrates > 50% within 24 to 48 hours, Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure AND Positive COVID-19 test via nasopharyngeal or pharyngeal PCR. Able to consent to treatment Exclusion Criteria: Unable to consent Lack of laboratory confirmed COVID-19 infection. Hospice/Palliative care Unable to tolerate 200mL of fluid. History of IgA deficiency (due to risk of reaction) History of anaphylactoid or other severe reaction to plasma or blood products. Philosophical/Religious objections to receiving blood products. Pregnant or breastfeeding
Sites / Locations
- Larkin Community Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Convalescent Plasma
Standard of care