Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

Phase 2

Completed

Conditions: SARS-CoV 2

Interventions: Biological: SARS-CoV-2 convalescent plasma
Biological: Plasma from a volunteer donor

Registration Number: NCT04373460

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1225

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 convalescent plasma	SARS-CoV-2 convalescent plasma	SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.
Standard Control plasma	Plasma from a volunteer donor	Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Primary Outcome Measures

Name	Time	Method
Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization	Up to day 28	Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Cumulative Incidence of Severe Infusion Reactions	Up to day 28	Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.
Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events	Up to day 90	Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)	Up to day 28	Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.

Secondary Outcome Measures

Name	Time	Method
Serum SARS-CoV-2 Antibody Titers by Visit	Days 0, 14, 28 and 90	Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.

Trial Locations

Locations (29): Western Connecticut Health Network, Danbury Hospital
🇺🇸
Danbury, Connecticut, United States
Western Connecticut Health Network, Norwalk Hospital
🇺🇸
Norwalk, Connecticut, United States
NorthShore University HealthSystem
🇺🇸
Evanston, Illinois, United States
University of California, Los Angeles
🇺🇸
Los Angeles, California, United States
University of Miami
🇺🇸
Coral Gables, Florida, United States
Center for American Indian Health - Chinle Office
🇺🇸
Chinle, Arizona, United States
University of Arizona, Tuscon
🇺🇸
Tucson, Arizona, United States
University of Arizona, Phoenix
🇺🇸
Tucson, Arizona, United States
University of Miami Clinical Translational Research Site
🇺🇸
Miami, Florida, United States
The Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
University of Massachusetts Worcester
🇺🇸
Worcester, Massachusetts, United States
MedStar Washington Hospital Center
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Hyattsville, Maryland, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Center for American Indian Health - Shiprock Office
🇺🇸
Shiprock, New Mexico, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Center for American Indian Health - Whiteriver Office
🇺🇸
Whiteriver, Arizona, United States
University of California, Irvine Health
🇺🇸
Orange, California, United States
Anne Arundel Medical Center
🇺🇸
Annapolis, Maryland, 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
Vassar Brothers Medical Center
🇺🇸
Poughkeepsie, New York, United States
University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
Lifespan/BrownUniversity (Rhode Island Hospital)
🇺🇸
Providence, Rhode Island, United States
Tulane University
🇺🇸
New Orleans, Louisiana, United States
The University of Utah
🇺🇸
Salt Lake City, Utah, United States
Wayne State University
🇺🇸
Detroit, Michigan, United States
University of Cincinnati Medical Center
🇺🇸
Cincinnati, Ohio, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Mayo Clinic, Phoenix
🇺🇸
Phoenix, Arizona, United States