Convalescent Plasma for COVID-19 Research Donor Study

NCT04555109 | Unknown DMC

• 1 other identifier: 1000070462
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; Convalescent plasma; Seroconversion; Immunity; National; Biorepository; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimen collection will include DNA, serum, plasma, peripheral blood mononuclear cells and whole blood.

MeSH Terms

Conditions

COVID-19; HIV Seropositivity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rulan Parekh, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Associate Chief Clinical Research

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 18, 2020
• Study Start: June 30, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)