Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

Inclusion criteria

• ≥ 18 years of age
• Competent and capable to provide informed consent
• • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab
• Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F), cough, or other COVID associated symptoms like anosmia
• ≤ 8 days since the first symptoms of COVID-19
• ≤ 8 days since first positive SARS-CoV-2 RNA test
• Able and willing to comply with protocol requirements listed in the informed consent

Exclusion criteria

• Hospitalized or expected to be hospitalized within 24 hours of enrollment
• Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
• History of prior reactions to transfusion blood products
• Inability to complete therapy with the study product within 24 hours after enrollment
• Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility