Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

Completed · Phase 2

Conditions studied: SARS-CoV 2

In brief

To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

Key facts

Study ID

NCT04373460

Run by

Johns Hopkins University

People needed

1225

Starts

2020-06-03

Expected to finish

2022-12-14

Last updated by the study team

2023-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Center for American Indian Health - Chinle Office — Chinle, Arizona, United States
• Mayo Clinic, Phoenix — Phoenix, Arizona, United States
• University of Arizona, Phoenix — Tucson, Arizona, United States
• University of Arizona, Tuscon — Tucson, Arizona, United States
• Center for American Indian Health - Whiteriver Office — Whiteriver, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Irvine Health — Orange, California, United States
• Western Connecticut Health Network, Danbury Hospital — Danbury, Connecticut, United States
• Western Connecticut Health Network, Norwalk Hospital — Norwalk, Connecticut, United States
• University of Miami — Coral Gables, Florida, United States
• University of Miami Clinical Translational Research Site — Miami, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Tulane University — New Orleans, Louisiana, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• MedStar Washington Hospital Center — Hyattsville, Maryland, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
• Center for American Indian Health - Gallup Office — Gallup, New Mexico, United States
• Center for American Indian Health - Shiprock Office — Shiprock, New Mexico, United States
• Vassar Brothers Medical Center — Poughkeepsie, New York, United States
• University of Rochester — Rochester, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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