Welcome to CONCOR–1

Clinical Trial Website

This trial is a North American collaboration involving clinicians, researchers and scientists from different fields and institutions

Welcome to CONCOR-1

Clinical Trial Website

This trial is a collaboration involving clinicians, researchers and scientists from different fields and institutions

SCROLL DOWN FOR AN IMPORTANT UPDATE ON RESULTS OF THE TRIAL!

Introduction

CONCOR-1: A Randomized, Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness

The research community together with four international blood suppliers has rallied together to rapidly mobilize this urgently needed clinical trial. The outpouring of support, energy, expertise and dedication reflects the intense spirit of collaboration.

The CONCOR-1 Trial aims to contribute to global efforts to study COVID-19 convalescent plasma as a potential treatment.

Canadian Blood Services, Héma-Québec, New York Blood Center and Hemorio collected convalescent plasma from donors who recovered from COVID-19 and who met all donor eligibility criteria.

Studies of this magnitude are designed, conducted and supported by huge teams of people. The CONCOR-1 Trial team is made up of a multidisciplinary group of experts including physicians, scientists, research coordinators, research assistants, students, biostatisticians, medical laboratory technologists and patient representatives.

Please direct your questions to: info@CONCOR1.ca

Introduction

CONCOR-1: A Randomized, Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness

The research community together with four international blood suppliers rallied together to rapidly mobilize this urgently needed clinical trial. The outpouring of support, energy, expertise and dedication reflects the intense spirit of collaboration.

The CONCOR-1 Trial aims to contribute to global efforts to study COVID-19 convalescent plasma as a potential treatment.

Canadian Blood Services, Héma-Québec, New York Blood Center and Hemorio collected convalescent plasma from donors who recovered from COVID-19 and who met all donor eligibility criteria.

Studies of this magnitude are designed, conducted and supported by huge teams of people. The CONCOR-1 Trial team is made up of a multidisciplinary group of experts including physicians, scientists, research coordinators, research assistants, students, biostatisticians, medical laboratory technologists and patient representatives.

Please direct your questions to: info@CONCOR1.ca

Trial Update:
Results of the CONCOR-1 trial are now available

CONCOR-1 (NCT 04348656) was a randomized, open-label clinical trial in which adults hospitalized with COVID-19 respiratory illness were randomized to receive convalescent plasma given by donors who had recovered from COVID-19 or standard treatments for COVID-19, which did not include convalescent plasma. In total, the study included 940 patients. The study was performed at 72 hospitals in Canada, the United States, and Brazil.

The CONCOR-1 trial stopped enrolment early, after its study safety monitoring committee indicated that convalescent plasma was not showing a benefit for patients. The study team then completed the follow-up and data entry for enrolled patients and analysed the data.

The average age of patients studied was 69 years, and 59% of patients were male. The average time from onset of respiratory symptoms to treatment was eight days. After thorough analysis, the study team determined that treatment with convalescent plasma did not reduce the risk of intubation or death in patients hospitalized for COVID-19 compared to patients who did not receive convalescent plasma. In addition, patients receiving convalescent plasma experienced significantly more serious adverse events – mainly increased need for oxygen and worsening lung function – compared to the patients who did not get convalescent plasma. The rate of fatal serious adverse events was not significantly different between those who received convalescent plasma, and those who did not. The study team concluded that convalescent plasma should not be given to COVID-19 hospitalized patients as part of their routine care outside of clinical trials.

In this study, samples from transfused convalescent plasma units were collected and analyzed for special proteins (antibodies) that recognize and eliminate the COVID-19 virus. The results showed that convalescent plasma has antibodies of different types, amounts and function – in other words the “antibody profile” can vary a lot from one convalescent plasma product to another. Our work identified a new aspect of antibody function; testing for this function allowed us to get a clearer picture of antibody potency. Different antibody profiles in the convalescent plasma were observed to significantly impact whether or not patients experienced intubation or death. Convalescent plasma with an unfavourable antibody profile appeared to increase the risk of intubation or death. More research is required to explore if specific convalescent plasma units could be beneficial for certain patients with COVID-19 or inform the appropriate use of plasma for future viral outbreaks.

The trial was funded by the Canadian Institutes of Health Research, Canadian Blood Services, Héma-Québec, Ontario Research Fund, Québec Ministère de l’Économie et de l’Innovation, the University of Toronto, the Government of Saskatchewan Ministry of Health, Sunnybrook Academic Health Sciences Centre, University Health Network, McMaster University, University Health Foundation at University of Alberta Hospital, Sunnybrook Hospital Foundation, CHU Ste. Justine Foundation, The Ottawa Hospital Academic Medical Organization, The Ottawa Hospital Foundation COVID-19 Research Fund, Sinai Health System Foundation, and numerous generous private donors.

This international collaboration included academic and community hospitals, a Community Advisory Committee and four blood suppliers – Canadian Blood Services, Héma-Québec, the New York Blood Center, and Hemorio. The dedication of thousands of people made this trial possible. We would like to sincerely thank the patients and their family members, plasma donors, research teams, Blood Bank staff, study investigators, the Community Advisory Committee, blood suppliers, and funders. Important knowledge has been gained and further research opportunities will be possible from the data and samples collected as part of the CONCOR-1 trial.

The article “Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial” was published in Nature Medicine. See HERE for a complete author list.

Co-principal investigators:

Donald Arnold, Professor of Medicine, McMaster University; Director, McMaster Centre for Transfusion Research

Jeannie Callum, Professor, Pathology and Molecular Medicine, Queen’s University; Associate Scientist, Sunnybrook Research Institute; and Professor, Lab Medicine and Pathobiology, University of Toronto

Philippe Bégin, Clinician Scientist, CHUM and CHU Sainte-Justine and Associate Professor, Université de Montréal

Frequently Asked Questions

What is convalescent plasma?

  • Plasma is the liquid part of the blood that contains proteins including some called antibodies. 
  • Antibodies are made by your body when it encounters an infection and can help fight off the infection. 
  • Convalescent plasma is plasma that has been collected from people who have recovered from an infection. A few weeks after recovery, people produce high quantities of antibodies.

Why is convalescent plasma being studied for COVID-19?

  • COVID-19 is the disease caused by a coronavirus strain called SARS-CoV2
  • Therapeutic options to treat COVID-19 are under study with data emerging.
  • Convalescent plasma has been given in the past to treat other types of Coronaviruses (eg. SARS) and other types of infections (e.g. Ebola and H1N1). 
  • As of early 2020, small and early studies done in other countries seemed promising; however, because the studies were small or did not have comparative control groups, we did not know if convalescent plasma would be an effective and safe treatment for COVID-19. 
  • CONCOR-1 is a large scale, controlled and scientifically rigorous study to determine if convalescent plasma is an effective and safe treatment for COVID-19. 

What will this trial study?

  • CONCOR-1 Trial is enrolling patients (16 or over) admitted to participating hospitals with COVID-19 related illness who require supplemental oxygen but who are not intubated/on ventilators and for whom there is available convalescent plasma.
  • All patients enrolled in the trial receive care as directed by their symptoms, health care team and patient-directives.
  • The trial compares the effect of transfusing 500mL of convalescent plasma to standard of care; patients are randomly assigned to receive convalescent plasma or not.

Please direct your questions to: info@CONCOR1.ca

CONCOR-1 Research Team

Studies of this magnitude are designed, conducted and supported by a large team:

Lead study investigators

Donald M. Arnold, MDCM, MSc, FRCP(C)
McMaster University

Dr. Donald Arnold is Associate Professor, Hematology and Thromboembolism, Department of Medicine, McMaster University; and Director of the McMaster Centre for Transfusion Research. His research focus is in blood transfusion practices, hemostasis and platelet disorders.  Dr. Arnold has lead several multi-center clinical trials and a translational research program in platelet disorders funded by the Canadian Institutes of Health Research and Canadian Blood Services.

Philippe Bégin, MD, PhD, FRCPC
CHU Sainte-Justine and the CHUM, Montreal

Dr Philippe Bégin is a clinician-scientist in the divisions of clinical immunology and allergy of the CHU Sainte-Justine and the CHUM in Montréal. Since the begining of the COVID-19 pandemic, he has been the leading the collaborative efforts between Héma-Québec, the Institut National d’Excellence en Santé et Service Sociaux (INESSS), Public Health and academic centers in the province of Québec for the urgent deployment of a passive immunization program using COVID-19 convalescent plasma.

Jeannie Callum, MD, FRCPC
Sunnybrook Health Sciences Center, Toronto

Dr. Jeannie Callum is a Transfusion Medicine Specialist and Hematologist at Sunnybrook Health Sciences Center in Toronto and Professor of the Department of Laboratory Medicine and Pathobiology at the University of Toronto. She is the Director of Utilization for the Department of Laboratory Medicine and Molecular Diagnostics. She is the sponsor lead for the Ontario Regional Blood Coordinating Network for Central Ontario and was helped develop the U.S. Biovigilance Network and the Canadian Transfusion Error Surveillance System.

  • The Trial Steering Committee is a group of individuals who provide oversight to the trial, have contributed to study design and provide ongoing advice and quality assurance.
  • The Research Team is supported by research coordinators, research assistants, bio-statisticians, medical laboratory technologists, students and others. Hundreds of hours of preparation have gone into designing this trial, and more will go into to ensuring it runs smoothly with maintained scientific rigor and integrity.
  • An Independent Scientific Data Safety Monitoring Committee is responsible for ensuring quality and safety of participants.
  • Investigators with expertise in transfusion, infectious disease and intensive care will be coordinating study conduct at each site.
  • The CONCOR-1 Community Advisory Committee (CAC) are 7 representatives of our diverse Canadian population bringing a wealth of lived experiences.

Please direct your questions to: info@CONCOR1.ca

Funding Agencies

Please direct your questions to: info@CONCOR1.ca

Recent Social Media Announcements

If you or your loved one are admitted to hospital with COVID-19 and want to participate, please ask your doctor whether the study is currently enrolling at their site

For further information: