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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348656
Recruitment Status : Terminated (Study was terminated after the planned interim analysis as the pre-defined futility threshold was met)
First Posted : April 16, 2020
Results First Posted : March 3, 2022
Last Update Posted : March 3, 2022
Sponsor:
Collaborators:
Canadian Blood Services
Héma-Québec
University of Toronto
Université de Montréal
Weill Medical College of Cornell University
New York Blood Center
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)
Actual Enrollment : 940 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 : March 14, 2020
Actual Primary Completion Date : March 5, 2021
Actual Study Completion Date : June 16, 2021


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. Number of Participants Who Were Intubated or Died [ Time Frame: Day 30 ]
    Endpoint of the need for intubation or patient death


Secondary Outcome Measures :
  1. Time to Intubation or In-hospital Death [ Time Frame: Day 30 ]
    Time in days from randomization to occurrence of intubation or death

  2. Ventilator-free Days by Day 30 [ Time Frame: Day 30 ]
    Number of days off ventilator at 30 days

  3. Death by Day 30 [ Time Frame: Day 30 ]
    Occurrence of patient death at 30 days

  4. Length of Stay in Intensive Care Unit (ICU) [ Time Frame: Day 30 ]
    Number of days spent in the intensive care unit (ICU) over the 30-day period following randomization

  5. Need for Renal Replacement Therapy [ Time Frame: Day 30 ]
    Need for new renal replacement therapy

  6. Need for Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: Day 30 ]
    Requirement for extracorporeal membrane oxygenation (ECMO)

  7. Development of Myocarditis [ Time Frame: Day 30 ]
    New diagnosis of myocarditis

  8. In-hospital Death [ Time Frame: Day 90 ]
    Occurrence of death while in hospital, censored at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.

  9. Time to In-hospital Death [ Time Frame: Day 90 ]
    Time to in-hospital death at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.

  10. Length of Stay in Hospital [ Time Frame: Day 90 ]
    Number of days from randomization to death or hospital discharge. Patients still in hospital at Day 30 were followed until Day 90 to capture death or discharge from hospital.

  11. Number of Participants With Grade 3 and 4 Serious Adverse Events [ Time Frame: Day 30 ]
    Number of participants with Grade 3 and 4 (CTCAE v4.0) serious adverse events, and cumulative incidence of Grade 3 and 4 serious adverse events (using MedDRA AE terms)

  12. Number of Participants With CCP Transfusion-associated Adverse Events (AE) [ Time Frame: Day 30 ]
    Number of participants experiencing CCP transfusion-associated adverse events (AE), as defined by the International Society of Blood Tranfusion (ISBT ) classification

  13. Number of Participants With Grade 3, 4, or 5 Serious Adverse Events [ Time Frame: Day 30 ]
    Number of Participants with Grade 3-5 (CTCAE v4.0) serious adverse events reported to Day 30

  14. Patient Reported Outcome Using Change in EQ-5D-5L Score [ Time Frame: Baseline and Day 30 ]
    Change in score on EQ-5D-5L instrument at Day 30 as compared to baseline. The EQ-5D-5L measures health-related quality of life in five dimensions, namely, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients can report five level impairment, reflecting no, slight, moderate, severe, and extreme problems in each dimension. The range of possible values is -0.148 to 0.949, with a higher score reflecting a better outcome. For the change in score, a positive number indicates that the scores improved from baseline.

  15. Patient Reported Outcome- Quality-adjusted Life Days [ Time Frame: Day 30 ]
    Quality-adjusted life days calculated using the EQ-5D-5L score. Quality-adjusted life days is a measure of how well a patient lives for how long. It combines the length of life and quality of life into one value. This is calculated by multiplying the health utility (derived from the EQ-5D-5L score) by the amount of time the patient is alive during the study period. A higher number is better.

  16. Cost of Intervention and Hospital Stay [ Time Frame: Day 30 ]
    Cost per patient calculated using cost of the intervention and costs of the hospital stay



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:   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 respiratory 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


Locations
Show Show 73 study locations
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Blood Services
Héma-Québec
University of Toronto
Université de Montréal
Weill Medical College of Cornell University
New York Blood Center
Investigators
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Principal Investigator: Donald M Arnold, MD McMaster University
  Study Documents (Full-Text)

Documents provided by McMaster University ( Hamilton Health Sciences Corporation ):
Study Protocol  [PDF] January 15, 2021
Statistical Analysis Plan  [PDF] March 19, 2021

Additional Information:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT04348656    
Obsolete Identifiers: NCT04418518
Other Study ID Numbers: CONCOR-1
First Posted: April 16, 2020    Key Record Dates
Results First Posted: March 3, 2022
Last Update Posted: March 3, 2022
Last Verified: March 2022
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases