CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)

NCT04348656 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: CONCOR-1
• Study Type: interventional
• Target: 940
• Locations: 3 countries
• Sites: 73

Brief Summary

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.

Conditions

COVID-19

Keywords

Convalescent plasma; Transfusion; SARS-CoV-2; Passive immunization

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Intubated or Died

  Endpoint of the need for intubation or patient death

  Day 30

Secondary Outcomes (16)

• Time to Intubation or In-hospital Death

  Day 30

• Ventilator-free Days by Day 30

  Day 30

• Death by Day 30

  Day 30

• Length of Stay in Intensive Care Unit (ICU)

  Day 30

• Need for Renal Replacement Therapy

  Day 30

Study Arms (2)

Convalescent plasma

EXPERIMENTAL

\~500 mL ABO compatible convalescent apheresis plasma

Biological: Convalescent plasma

Standard of care

NO INTERVENTION

Treated as per institutional standard of care.

Interventions

Convalescent plasma BIOLOGICAL

Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.

Convalescent plasma

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Blood Services: collaborator
• Héma-Québec: collaborator
• University of Toronto: collaborator
• Université de Montréal: collaborator
• Weill Medical College of Cornell University: collaborator
• New York Blood Center: collaborator

Study Sites (73)

Brooklyn Hospital

Brooklyn, New York, 11201, United States

Location

Lower Manhattan Hospital

New York, New York, 10038, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Hospital Universitário Antônio Pedro (HUAP)

Niterói, 24070-035, Brazil

Location

Hemario

Rio de Janeiro, 20211-030, Brazil

Location

Peter Lougheed Center

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

University of Alberta - Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

Fraser Health Authority - Abbotsford Regional Hospital and Cancer Centre

Abbotsford, British Columbia, V2S 0C2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Grace General Hospital

Winnipeg, Manitoba, R3J 3M7, Canada

Location

Vitalité Health Network - Acadie-Bathurst

Bathurst, New Brunswick, E2A 4L7, Canada

Location

Vitalité Health Network - Restigouche

Campbellton, New Brunswick, E3N 3G2, Canada

Location

Vitalité Health Network- Northwest

Edmundston, New Brunswick, E3V 4E4, Canada

Location

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, E1C 2Z3, Canada

Location

Lakeridge Health Ajax Pickering

Ajax, Ontario, L1S 2J4, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, M6R 1B5, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

St. Mary's Hospital

Kitchener, Ontario, N2M 1B2, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Markham Stouffville Hospital

Markham, Ontario, L3P 7P3, Canada

Location

Trillium Health Partners - Mississauga Hospital

Mississauga, Ontario, L5B 1B8, Canada

Location

Trillium Health Partners - Credit Valley

Mississauga, Ontario, L5M 2N1, Canada

Location

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Queensway Carleton Hospital

Ottawa, Ontario, K2H 8P4, Canada

Location

Niagara Health System - St. Catherines

Saint Catherines, Ontario, L2S 0A9, Canada

Location

Bluewater Health

Sarnia, Ontario, N7T 6S3, Canada

Location

Scarborough Health Network, Centenary Hospital

Scarborough Village, Ontario, M1E 4B9, Canada

Location

Scarborough Health Network, General Hospital

Scarborough Village, Ontario, M1P 2V5, Canada

Location

Scarborough Health Network, Birchmount Hospital

Scarborough Village, Ontario, M1W 3W3, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Unity Health St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Unity Health, St. Joseph's Health Care Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Windsor Regional Hospital - Metropolitan Campus

Windsor, Ontario, N8W 1L9, Canada

Location

Windsor Regional Hospital - Ouellette Campus

Windsor, Ontario, N9A 1E1, Canada

Location

L'Hopital Chicoutimi

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Hôpital de la Cité-de-la-Santé

Laval, Quebec, H7M 3L9, Canada

Location

Hotel Dieu Hospital of Lévis

Lévis, Quebec, G6V 3Z1, Canada

Location

Hôpital Charles-Le Moyne

Longueuil, Quebec, J4V 2H1, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Montréal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire (CHU) de Québec - Université Laval

Québec, Quebec, G1R 2J6, Canada

Location

Institut Universitaire de cardiologie et pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Centre hospitalier régional de St-Jérôme

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hôpital Hôtel-Dieu

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hôpital Fleurimont

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Centre hospitalier affilié universitaire régional de Trois-Rivières

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

Pasqua Hospital

Regina, Saskatchewan, S4T 1A5, Canada

Location

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (4)

• Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31.

  PMID: 32014114 BACKGROUND

• 2. FDA USFDA. Investigational COVID-19 Convalescent Plasma - Emergency INDs [Web]. 2020 [Available from: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds accessed March 26th 2020.

  BACKGROUND

• Begin P, Callum J, Jamula E, Cook R, Heddle NM, Tinmouth A, Zeller MP, Beaudoin-Bussieres G, Amorim L, Bazin R, Loftsgard KC, Carl R, Chasse M, Cushing MM, Daneman N, Devine DV, Dumaresq J, Fergusson DA, Gabe C, Glesby MJ, Li N, Liu Y, McGeer A, Robitaille N, Sachais BS, Scales DC, Schwartz L, Shehata N, Turgeon AF, Wood H, Zarychanski R, Finzi A; CONCOR-1 Study Group; Arnold DM. Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial. Nat Med. 2021 Nov;27(11):2012-2024. doi: 10.1038/s41591-021-01488-2. Epub 2021 Sep 9.

  PMID: 34504336 DERIVED

• Begin P, Callum J, Heddle NM, Cook R, Zeller MP, Tinmouth A, Fergusson DA, Cushing MM, Glesby MJ, Chasse M, Devine DV, Robitalle N, Bazin R, Shehata N, Finzi A, McGeer A, Scales DC, Schwartz L, Turgeon AF, Zarychanski R, Daneman N, Carl R, Amorim L, Gabe C, Ellis M, Sachais BS, Loftsgard KC, Jamula E, Carruthers J, Duncan J, Lucier K, Li N, Liu Y, Armali C, Kron A, Modi D, Auclair MC, Cerro S, Avram M, Arnold DM. Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial. Trials. 2021 May 4;22(1):323. doi: 10.1186/s13063-021-05235-3.

  PMID: 33947446 DERIVED

Related Links

• Publication of trial results in Nature Medicine

MeSH Terms

Conditions

COVID-19

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

Results Point of Contact

• Title: Dr Donald Arnold
• Organization: McMaster University/Hamilton Health Sciences

arnold@mcmaster.ca

905 525 9140

Study Officials

• Donald M Arnold, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: March 14, 2020
• Primary Completion: March 5, 2021
• Study Completion: June 16, 2021
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2); CA (68); US (3)