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Convalescent Plasma for COVID-19 Research Donor Study (CONCOR-Donor)

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: NCT04555109
Recruitment Status : Active, not recruiting
First Posted : September 18, 2020
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Rulan Parekh, The Hospital for Sick Children

Study Description
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Brief Summary:
Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, natural history study of plasma donors recovered from COVID-19. CONCOR-Donor study will address immune response, duration of protective immunity, and clinical factors and host genetics contributing to the variability of immune response. We will also study long-term outcomes from COVID-19 infection. Results from the study will help define therapeutic strategies for COVID-19.

Condition or disease
Covid19

Detailed Description:

The outbreak caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) led to the global pandemic. There are currently no proven treatments for coronavirus disease (COVID-19), however, convalescent plasma has emerged as a potential therapeutic to prevent clinical deterioration. Convalescent plasma was successfully used for other infections, in small numbers, but there is limited evidence for the efficacy of administering specific, neutralizing antibodies by transfusion of convalescent plasma. The unknown role for convalescent plasma in treating COVID-19 necessitates further study.

As trials are underway to determine efficacy of using convalescent plasma, we will use this unique opportunity to conduct a national longitudinal cohort study of 1000 persons recovered from COVID-19 and volunteer to donate convalescent plasma. Our aims are to:1) determine if the variability of titers of viral neutralizing antibody and ELISA antibody are associated with clinical and demographic factors; 2) determine duration of protective immunity in recovered persons over 1 year and if modified by clinical and demographic factors; 3) determine genetic risk predictors of the antibody response, and 4) create a biorepository available to researchers from across Canada. Based on the World Health Organization (WHO) Coordinated Global Research Map, this project addresses the priority of the natural history of COVID-19 and clinical characterization of antibody response in the convalescent phase and beyond.

Study Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Convalescent Plasma for COVID-19 Research (CONCOR) Donor Study
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
COVID-19 Convalescents
The cohort will include up to 1000 persons recovered from COVID-19, ages 17 - 65, that will provide a written consent form to participate in the study, complete questionnaires and provide a blood sample.


Outcome Measures
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Primary Outcome Measures :
  1. Seroprevalence and duration of protective immunity [ Time Frame: 12 months ]
    Determine if the titers of SARS-CoV-2-specific neutralizing antibody and serum ELISA antibodies, are correlated with clinical and demographic factors such as age, sex, comorbidities, geographic region, and severity of prior COVID-19 symptoms, during the convalescent phase.


Biospecimen Retention:   Samples With DNA
Specimen collection will include DNA, serum, plasma, peripheral blood mononuclear cells and whole blood.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All that recovered from COVID-19 above age 17, that have tested positive or a household contact that tested positive regardless of eligibility to donate plasma for the trials.
Criteria

Inclusion Criteria:

  • Recovered from COVID-19 infection
  • Have a positive PCR or serology or a positive household contact
  • Signed informed consent form
  • Provide blood sample
  • Ability to complete a questionnaire

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT04555109


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Rulan Parekh, MD The Hospital for Sick Children
More Information
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Additional Information:

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Responsible Party: Rulan Parekh, Staff Physician, Associate Chief Clinical Research, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04555109    
Other Study ID Numbers: 1000070462
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rulan Parekh, The Hospital for Sick Children:
Covid19
Convalescent plasma
Seroconversion
Immunity
 National
Biorepository
Observational Study
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