Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness

ISC.20.11.2

Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. This phase is to test the safety and efficacy of CP therapy.

2020-12-01

2021-06-30

2021-07-30

Completed

Early phase I

4

Inclusion Criteria: * Age 18-75 years * SARS-CoV-19 PCR positive * Moderate stage and above * Time from onset to screening ≤ 21 days, the SARS-CoV-2 test is still positive Exclusion Criteria: * Patients with a history of autoimmune disease or IgA deficiency * Patients with a history of allergy * Multi-organ/system failure * Pregnant or breastfeeding at the time of study * Cancer, history of heart failure, stroke, bronchial asthma * Multi-organ/system failure with indications for dialysis, severe hypoxia, failure with conventional treatment methods, indications for ECMO. * The patient is infected with multidrug-resistant bacteria. * The patient is participating in another study. * Time from onset to screening\> 21 days

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2024-06-05