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Convalescent Plasma for COVID-19 Close Contacts

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: NCT04390503
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica E Justman, MD, Columbia University

Brief Summary:
This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in two groups, RT PCR-positive and asymptomatic or mildly symptomatic at baseline (group B) and PCR-negative at baseline (group C). Both groups will be randomized 1:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or control (albumin 5%).

Condition or disease Intervention/treatment Phase
SARS-CoV 2 COVID-19 Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma) Biological: Control (albumin 5%) Phase 2

Detailed Description:
There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 200 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or control (albumin 5%)
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti- SARS-CoV-2 Plasma in Close Contacts of COVID-19 Cases
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Participants randomized to the experimental arm will receive 1 unit (approximately 200 to 250 mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Convalescent Plasma that contains antibody titers against SARS-CoV-2.

Active Comparator: Control (albumin 5%)
Participants randomized to the control arm will receive 250 mL of albumin (human) 5% infusion. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
Biological: Control (albumin 5%)
Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.




Primary Outcome Measures :
  1. Rate of Severe Disease [ Time Frame: Up to 28 days ]
    The efficacy of treatment will be determined by rating disease severity on Day 28, or last rating evaluated, using a seven-category severity scale.


Secondary Outcome Measures :
  1. Rate of measurable anti-SARS-CoV-2 titers [ Time Frame: Up to 90 days ]
    To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).

  2. Rate of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 28 days ]
    Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).

  3. Duration of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 28 days ]
    Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).

  4. Levels of SARS-CoV-2 RNA [ Time Frame: Up to 28 days ]
    Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)



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:

Group B: SARS-CoV-2 PCR positive but asymptomatic or mild symptoms at screening

  • Subjects must be 18 years of age or older
  • Close contact* of a person with COVID-19 within the last 7 days. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts.
  • Evidence of infection by nasopharyngeal swab PCR that is positive for SARS-CoV-2
  • No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms+ may include:

    • Mild rhinorrhea
    • Mild sore throat or throat irritation
    • Mild nonproductive cough
    • Mild fatigue (able to perform Activities of Daily Living (ADLs))
  • High risk for severe COVID-19 based on a risk score of ≥ 2 Calculated Risk Score of ≥ 2 points, with risk factors based on Center for Disease Control and Prevention (CDC) description

    • Age 65-74: 1 point
    • Age ≥ 75: 2 points
    • Known cardiovascular disease (including hypertension): 1 point
    • Diabetes mellitus: 1 point
    • Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point
    • Morbid obesity: 1 point
    • Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count <200 cells/mL).

      • Mild symptoms are rated by participant as mild and not interfering with normal daily activities

Group C: SARS-CoV-2 PCR negative (uninfected) at time of screening but asymptomatic or mildly symptomatic at screening

  • Subjects must be 18 years of age or older
  • Close contact* of a person with COVID-19 within the last 7 days. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts.
  • Nasopharyngeal swab negative for SARS-Cov-2 at screening
  • No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms+ may include:

    • Mild rhinorrhea
    • Mild sore throat or throat irritation
    • Mild nonproductive cough
    • Mild fatigue (able to perform ADLs)
  • High risk for severe COVID-19 based on a risk score of ≥ 2, as above.*

    • Close contact is defined by CDC as being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time (without PPE); close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 case.

      • Mild symptoms are rated by participant as mild and not interfering with normal daily activities

Exclusion Criteria:

Group B: SARS-CoV-2 PCR positive but asymptomatic or mild symptoms at screening

  • Receipt of 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.
  • Confirmed or self-reported presumed COVID-19 at least one week before index case first became ill with COVID-19.
  • Symptoms consistent with COVID---19 infection that are more than mild (as defined above) at time of screening. Subjects who report fever (Tmax > 100.4 F) are not eligible for enrollment.
  • Symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medical unstable on the day of planned enrollment.
  • History of allergic reaction to transfusion blood products
  • Inability to complete infusion of the product within 48 hours after randomization.
  • Pregnancy (or planning for pregnancy in next three months) or breastfeeding.
  • Resident of a long term or skilled nursing facility
  • Known prior diagnosis of immunoglobulin A (IgA) deficiency
  • Oxygen saturation that is < 95% at the screening visit
  • Participation in another clinical trial of anti-viral agent(s) for COVID-19

Group C: SARS-CoV-2 PCR negative (uninfected) at time of screening

  • Receipt any blood product in past 120 days.
  • Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principle investigator, would affect subject safety and/or compliance.
  • Confirmed or self-reported presumed COVID-19 at least one week before index case first became ill with COVID-19.
  • Symptoms consistent with severe COVID-19 infection that are more than mild (as defined above) at time of screening. Subjects who report fever (Tmax > 100.4 F) are not eligible for enrollment.
  • Symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medically unstable on the day of planned enrollment.
  • Laboratory evidence of SARs-CoV-2 infection (i.e. RT-PCR) at time of screening
  • History of allergic reaction to blood products
  • Inability to complete infusion of the product within 48 hours after randomization.
  • Pregnancy (or planning for pregnancy in next three months) or breastfeeding.
  • Resident of a long term or skilled nursing facility
  • Known history of immunoglobulin A (IgA) deficiency
  • Oxygen saturation that is < 95% at the screening visit
  • Participation in another clinical trial of anti-viral agent(s) for COVID-19

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): NCT04390503


Contacts
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Contact: Jessica Justman, MD 212-342-0537 jj2158@cumc.columbia.edu
Contact: Jennifer Zech, MSc 212-304-5506 jz2973@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center/NYP Recruiting
New York, New York, United States, 10032
Contact: Jessica Justman, MD    212-342-0537    jj2158@cumc.columbia.edu   
Contact: Jennifer Zech, MSc    212-304-5506    jz2973@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Jessica Justman, MD Columbia University
Publications:

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Responsible Party: Jessica E Justman, MD, Associate Professor of Medicine (in Epidemiology and ICAP), Columbia University
ClinicalTrials.gov Identifier: NCT04390503    
Other Study ID Numbers: AAAT0052
First Posted: May 15, 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica E Justman, MD, Columbia University:
Coronavirus
COVID
Convalescent Plasma