Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection

• Status: Withdrawn
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP during a viral pandemic must consider the supply of the product, ideal patient selection, and appropriate timing in order to produce maximum benefit with a scarce resource [2]. Currently, the FDA suggested guidelines for use include "severe", "critical" or at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2 antibodies is theoretically early in the course of the illness [1], before multiorgan failure or a maladaptive immune response, like seen in the cytokine release syndrome, occurs. Our open-label trial will randomize COVID-19+ patients admitted to the hospital who are at high risk for severe disease to receive 1 dose CP ordered within 48 hours of admission plus standard of care vs. standard of care. The primary clinical endpoint will be time to clinical improvement within 28 days after randomization (based on the ordinal scale as specified below). The purpose of this trial will be to obtain data which can be further utilized in future clinical trials and help clinicians understand the effectiveness of CP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Larkin Community Hospital

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