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CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1) (CONCOR-1)

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: NCT04348656
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Canadian Blood Services
Héma-Québec
University of Toronto
Université de Montréal
Weill Cornell Medicine/New York-Presbyterian
New York Blood Centre
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )

Brief Summary:

There is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection.

The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19.

It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay.

This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent plasma Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Convalescent plasma
~500 mL ABO compatible convalescent apheresis plasma
Biological: Convalescent plasma
Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.

No Intervention: Standard of care
Treated as per institutional standard of care.



Primary Outcome Measures :
  1. Intubation or death in hospital [ Time Frame: Day 30 ]
    Endpoint of the need for intubation or patient death in hospital


Secondary Outcome Measures :
  1. Need for Intubation [ Time Frame: Day 30 ]
    Endpoint of the need for intubation before 30 days

  2. Time to intubation [ Time Frame: Day 30 ]
    Time in hours to intubation from randomization

  3. Ventilator-free days [ Time Frame: Day 30 ]
    Endpoint of the number of days off ventilator at 30 days

  4. In-hospital death [ Time Frame: 90 days ]
    In-hospital death censored at 90 days

  5. Time to in-hospital death [ Time Frame: Day 90 ]
    Time to in-hospital death at 90 days

  6. Death at 30 days [ Time Frame: 30 days ]
    Death at 30 days

  7. Length of stay in intensive care unit (ICU) [ Time Frame: Day 30 ]
    Date of intensive care unit admission (first date and total number of days)

  8. Length of stay in hospital [ Time Frame: Day 30 ]
    Date of hospital admission (first date and total number of days)

  9. Need for extracorpeal membrane oxygenation (ECMO) [ Time Frame: Day 30 ]
    First date on ECMO and total number of days

  10. Need for renal replacement therapy [ Time Frame: Day 30 ]
    Need for renal replacement therapy

  11. Development of myocarditis [ Time Frame: Day 30 ]
    New myocarditis

  12. Adverse events and serious adverse events [ Time Frame: Day 30 ]
    Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)

  13. CCP transfusion-associated adverse events (AE) [ Time Frame: 30 days ]
    CCP transfusion-associated adverse events (AE)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥16 years old (>18 years of age in the United States)
  • Admitted to hospital with confirmed COVID-19 respiratory illness
  • Receiving supplemental oxygen
  • 500 mL of ABO compatible convalescent plasma is available

Exclusion Criteria:

  • Onset of symptoms >12 days prior to randomization
  • Intubated or plan in place for intubation
  • Plasma is contraindicated (e.g. history of anaphylaxis from transfusion)
  • Decision in place for no active treatment

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): NCT04348656


Contacts
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Contact: Donald M Arnold, MD 9055259140 ext 28603 arnold@mcmaster.ca
Contact: Erin B Jamula, MSc. 9055259140 ext 21845 jamulae@mcmaster.ca

Locations
Show Show 31 study locations
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Blood Services
Héma-Québec
University of Toronto
Université de Montréal
Weill Cornell Medicine/New York-Presbyterian
New York Blood Centre
Investigators
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Principal Investigator: Donald M Arnold, MD McMaster University
Publications:
2. FDA USFDA. Investigational COVID-19 Convalescent Plasma - Emergency INDs [Web]. 2020 [Available from: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds accessed March 26th 2020.

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT04348656    
Other Study ID Numbers: CONCOR-1
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
Convalescent plasma
Transfusion
SARS-CoV-2
Passive immunization