Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Convalescent Plasma to Stem Coronavirus (CSSC-001) (CSSC-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323800
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Coronavirus Convalescence Biological: Anti- SARS-CoV-2 Plasma Biological: SARS-CoV-2 non-immune Plasma Phase 2

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 and at higher risk for severe illness and/or who are health care personnel (HCP) with high risk exposure as defined by CDC may participate. A total of 150 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 487 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High titer anti-SARS-CoV-2 plasma
Participants with High titer anti-SARS-CoV-2 plasma.
Biological: Anti- SARS-CoV-2 Plasma
SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and was found to have a titer of neutralizing antibody >1:64)

Active Comparator: SARS-CoV-2 non-immune plasma
Participants with SARS-CoV-2 non-immune plasma.
Biological: SARS-CoV-2 non-immune Plasma
Standard plasma collected prior to December 2019




Primary Outcome Measures :
  1. Cumulative incidence of composite outcome of disease severity [ Time Frame: Day 28 ]

    The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following:

    1. Death
    2. Requiring mechanical ventilation and/or in ICU
    3. non-ICU hospitalization, requiring supplemental oxygen;
    4. non-ICU hospitalization, not requiring supplemental oxygen;
    5. Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection
    6. Not hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2


Secondary Outcome Measures :
  1. Anti-SARS-CoV-2 titers [ Time Frame: Baseline ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 0 (baseline).

  2. Anti-SARS-CoV-2 titers [ Time Frame: Day 1 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 1.

  3. Anti-SARS-CoV-2 titers [ Time Frame: Day 3 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 3.

  4. Anti-SARS-CoV-2 titers [ Time Frame: Day 7 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 7.

  5. Anti-SARS-CoV-2 titers [ Time Frame: Day 14 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 14.

  6. Anti-SARS-CoV-2 titers [ Time Frame: Day 90 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 90.

  7. Rates of SARS-CoV-2 PCR positivity [ Time Frame: Up to day 28 ]
    Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

  8. Duration of SARS-CoV-2 PCR positivity [ Time Frame: Up to day 28 ]
    Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

  9. Peak quantity levels of SARS-CoV-2 RNA [ Time Frame: Up to day 28 ]
    Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28 days.

  10. Cumulative incidence of disease severity [ Time Frame: up to Day 28 ]

    Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28):

    1. Death
    2. Requiring mechanical ventilation and/or in ICU
    3. non-ICU hospitalization, requiring supplemental oxygen;
    4. non-ICU hospitalization, not requiring supplemental oxygen;
    5. Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Subjects must be 18 years of age or older
  2. Close contact* exposure to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma) High risk exposure as defined by CDC: Living in the same household as, being an intimate partner of, or providing care in a nonhealthcare setting (such as a home) for a person with symptomatic laboratory-confirmed COVID-19 infection without using recommended precautions for home care and home isolation AND
  3. Higher risk for severe illness as defined by CDC (any of the following):

    3.1 >= 65 years of age 3.2 Residence in a nursing home or long-term care facility 3.3 Chronic lung disease or moderate to severe asthma 3.4 Heart disease 3.5 Immunocompromising condition including cancer treatment 3.6 Severe obesity (body mass index [BMI] >40) 3.7 Uncontrolled diabetes 3.8 Renal failure 3.9 Liver disease AND/OR

  4. High risk HCP exposure as defined by CDC (any of the following) 4.1 HCP who have had prolonged close contact with patients with COVID-19 who were not wearing a facemask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.

4.2 Being present in the room for procedures that generate aerosols or during which respiratory secretions are likely to be poorly controlled (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction) on patients with COVID-19 when the healthcare providers' eyes, nose, or mouth were not protected

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 of prior reactions to transfusion blood products
  6. Inability to complete therapy with the study product within 24 hours after enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323800


Contacts
Layout table for location contacts
Contact: Shmuel Shoham, MD 410-614-6702 TOID_CRC@jhmi.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Faye Heard    206-996-4405    fhoward@uabmc.edu   
Principal Investigator: Sonya Heath         
United States, California
University of California, San Diego Not yet recruiting
La Jolla, California, United States, 92093
Contact: Leander Lazaro    858-822-3708    llazaro@health.ucsd.edu   
Contact: Archana Bhatt    858-822-2661    abhatt@health.ucsd.edu   
Principal Investigator: Edward Cachay, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Jenny Ahn    310-267-2273    JennyAhn@mednet.ucla.edu   
Principal Investigator: Judith Currier, MD         
University of California, Irvine Health Not yet recruiting
Orange, California, United States, 92868
Contact: Anthony Warner    949-824-1114    acwarner@hs.uci.edu   
Principal Investigator: Don Forthal, MD         
United States, District of Columbia
MedStar Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Max Menna    202-444-0357    mpm229@georgetown.edu   
Principal Investigator: Seble Kassaye, MD         
United States, Florida
Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Jane Mernow    239-292-7291    jane.wernow@leehealth.org   
Contact: Michelle Deckard    239-292-7291    michelle.deckard@leehealth.org   
Principal Investigator: Douglas Brust, MD         
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Brittney Adams       BAdams@northshore.org   
Principal Investigator: Giselle Mosnaim, MD, MS         
United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Contact: Jaci Miller    443-481-5738    jmiller9@aahs.org   
Principal Investigator: Barry Meisenberg, MD         
JHSPH Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Laura Hammitt    443-651-0000    lhammitt@jhu.edu   
Contact: Carol Tso    505-722-6372    ctso1@jhu.edu   
Principal Investigator: Robert Weatherholtz, BS         
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Thuy Anderson, RN    443-287-8942    tander34@jhmi.edu   
Principal Investigator: Shmuel Shoham, MD         
United States, Massachusetts
University of Massachusetts Worcester Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Alexandra Agrillo    774-455-4456    alexandra.agrillo@umassmed.edu   
Principal Investigator: Jonathan Gerber, MD         
United States, New York
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Susanne Heininger    585-273-1926    Susanne_Heininger@URMC.Rochester.edu   
Principal Investigator: Martin Zand, MD, PhD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Sharon Kohrs    513-584-6383    kohrssd@ucmail.uc.edu   
Principal Investigator: Moises Huaman, MD         
United States, Rhode Island
Lifespan/BrownUniversity (Rhode Island Hospital) Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kristin Basso    401-444-2936    kristin.basso@lifespan.org   
Contact: Jheraldines Paulino    401-444-3374    jheraldines.paulino@lifespan.org   
Principal Investigator: Adam Levine, MD         
United States, Texas
University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Mary Ayad    713-704-5198    mary.ayad@uth.tmc.edu   
Principal Investigator: Bela Patel, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Shmuel Shoham, MD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04323800    
Other Study ID Numbers: IRB00245634
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing is governed by Johns Hopkins University Institutional Guidelines

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Convalescence
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes