Convalescent Plasma for COVID-19 Research Donor Study

NCT ID: NCT04555109

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-10-31

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.

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Rulan Parekh

Staff Physician, Associate Chief Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rulan Parekh, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000070462

Identifier Type: -

Identifier Source: org_study_id