CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
Stopped early · Phase 3
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04348656
- Run by
- Hamilton Health Sciences Corporation
- People needed
- 940
- Starts
- 2020-03-14
- Expected to finish
- 2021-06-16
- Last updated by the study team
- 2022-03-03
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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
Where it is running
- Lower Manhattan Hospital — New York, New York, United States
- Weill Cornell Medical Center — New York, New York, United States
- Hospital Universitário Antônio Pedro (HUAP) — Niterói, Brazil
- Hemario — Rio de Janeiro, Brazil
- Peter Lougheed Center — Calgary, Alberta, Canada
- Foothills Medical Centre — Calgary, Alberta, Canada
- Rockyview General Hospital — Calgary, Alberta, Canada
- University of Alberta - Royal Alexandra Hospital — Edmonton, Alberta, Canada
- University of Alberta Hospital — Edmonton, Alberta, Canada
- Sturgeon Community Hospital — St. Albert, Alberta, Canada
- Fraser Health Authority - Abbotsford Regional Hospital and Cancer Centre — Abbotsford British Columbia, British Columbia, Canada
- Vancouver General Hospital — Vancouver, British Columbia, Canada
- St. Paul's Hospital — Vancouver, British Columbia, Canada
- Royal Jubilee Hospital — Victoria, British Columbia, Canada
- Victoria General Hospital — Victoria, British Columbia, Canada
- St. Boniface General Hospital — Winnipeg, Manitoba, Canada
- Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada
- Grace General Hospital — Winnipeg, Manitoba, Canada
- Vitalité Health Network - Acadie-Bathurst — Bathurst, New Brunswick, Canada
- Vitalité Health Network - Restigouche — Campbellton, New Brunswick, Canada
- Vitalité Health Network- Northwest — Edmundston, New Brunswick, Canada
- Dr. Georges-L.-Dumont University Hospital Centre — Moncton, New Brunswick, Canada
- Lakeridge Health Ajax Pickering — Ajax, Ontario, Canada
- Hamilton General Hospital — Hamilton, Ontario, Canada
- Brooklyn Hospital — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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