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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 : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : May 15, 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Study Start Date : May 15, 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.


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

Inclusion Criteria:

  • Subjects must be 18 years of age or older
  • 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

Higher risk for severe illness as defined by CDC (any of the following):

  • 65 years of age

    • 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
    • Severe obesity (body mass index [BMI] >40)
    • Uncontrolled diabetes
    • Renal failure
    • Liver disease

Exclusion Criteria:

  • Receipt any blood product in past 120 days
  • Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
  • Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening
  • Nucleic acid testing evidence of COVID-19 infection at time of screening
  • History of prior reactions to transfusion blood products
  • 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
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Contact: Shmuel Shoham, MD 410-614-6702 TOID_CRC@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Shmuel Shoham, MD Johns Hopkins University
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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: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing is governed by Johns Hopkins University Institutional Guidelines

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Studies a U.S. FDA-regulated Drug Product: No
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:
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Coronavirus Infections
Convalescence
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes