Clinical trial NCT04323800: Convalescent Plasma to Stem Coronavirus (CSSC-001)
Official title: Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus
Convalescence
Keywords: COVID-19
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 ratio
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

Detailed description: This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Eligibility criteria: Inclusion Criteria

1. Subjects must be 18 years of age or older
2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within 96 hours of randomization (and 120 hours of receipt of plasma)

Exclusion Criteria

1. Receipt of any blood product in past 120 days.
2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening.
4. Laboratory evidence of COVID-19 infection at time of screening.
5. History or known laboratory evidence of previous COVID-19 infection.
6. History of prior reactions to transfusion blood products.
7. Inability to complete therapy with the study product within 24 hours after randomization.

Primary outcomes:
measure: Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection
timeFrame: Day 28
measure: Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"
timeFrame: Up to Day 28
measure: Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events
timeFrame: Up to Day 28
Secondary outcomes:
measure: Number of Participants With Severe Disease
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Whiteriver
country: United States
facility: Center for American Indian Health - Whiteriver Office
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Orange
country: United States
facility: University of California, Irvine Health
state: California
city: Danbury
country: United States
facility: Western Connecticut Health Network, Danbury Hospital
state: Connecticut
city: Norwalk
country: United States
facility: Western Connecticut Health Netowrk, Norwalk Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: University of Miami Clinical Translational Research Site
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Worcester
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Gallup
country: United States
facility: Center for American Indian Health - Gallup Office
state: New Mexico
city: Shiprock
country: United States
facility: Center for American Indian Health - Shiprock Office
state: New Mexico
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Providence
country: United States
facility: Lifespan/BrownUniversity (Rhode Island Hospital)
state: Rhode Island
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
Study officials:
affiliation: Johns Hopkins University
name: Shmuel Shoham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan D. Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection. medRxiv [Preprint]. 2021 Dec 14:2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611.