Convalescent Plasma for COVID-19 Research Donor Study

Covid19 Clinical Trial

— CONCOR-Donor  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04555109
• Other study ID #: 1000070462
• Status: Active, not recruiting
• Start date: June 30, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprevalence and duration of protective immunity	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.	12 months

External Links

•   CONCOR-Donor website