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

• ClinicalTrials.gov Identifier: NCT04348656
• Recruitment Status: Terminated
• First Posted: April 16, 2020
• Results First Posted: March 3, 2022
• Last Update Posted: March 3, 2022
• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Canadian Blood Services; Héma-Québec; University of Toronto; Université de Montréal; Weill Medical College of Cornell University; New York Blood Center
• Information provided by (Responsible Party): McMaster University ( Hamilton Health Sciences Corporation )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Biological: Convalescent plasma	Phase 3

Detailed Description:

Problem to be addressed: In December 2019, the Wuhan Municipal Health Committee (Wuhan, China) identified an outbreak of viral pneumonia cases of unknown cause. Coronavirus RNA was quickly identified in some of these patients.This novel coronavirus has been designated SARS-CoV-2, and the disease caused by this virus has been designated COVID-19.Outbreak forecasting and mathematical modelling suggest that these numbers will continue to rise [1] in many countries over the coming weeks to months.Global efforts to evaluate novel antivirals and therapeutic strategies to treat COVID-19 have intensified. There is an urgent public health need for rapid development of novel interventions. At present, there is no specific antiviral therapy for coronavirus infections.

Passive immunization:Passive immunization consists in the transfer of antibodies from immunized donor to non-immunized individual in order to transfer transient protection against an infective agent. A physiological example of passive immunization is the transfer of maternal IgG antibodies to the foetus through the placenta to confer humoral protection to newborns in the first years of life. Passive immunization differs from active immunization in which the patient develops their own immune response following contact with the infective agent or vaccine.

Known potential risks and benefits: There is a theoretical risk of antibody-dependent enhancement of infection (ADE) through which virus targeted by non-neutralizing antibodies gain entry into macrophages. Another theoretical risk is that antibody administration to those exposed to SARS-CoV-2 may avoid disease but modify the immune response such that those individuals mount attenuated immune responses, which would leave them vulnerable to subsequent re-infection. Finally, there are risks associated with any transfusion of plasma including transmission of blood transmitted viruses (e.g. HIV, HBV, HCV, etc.), allergic transfusion reactions, including anaphylaxis, febrile non hemolytic transfusion reaction, transfusion related acute lung injury (TRALI), transfusion associated cardiac overload (TACO), and hemolysis should ABO incompatible plasma be administered. Potential benefits of COVID-19 convalescent plasma include improved survival, improvement in symptoms, decreased risk in intubation for mechanical ventilation, decrease risk of intensive care unit (ICU) admission, shortened hospitalization time and suppression of viral load.

Mechanism of action: Transfusion of apheresis frozen plasma (AFP) from COVID-19 convalescent patients allows the transfer of donor neutralizing antibodies directed against SARS-CoV2 antigens to the recipient, thus allowing the generation of passive immunization. Naturally produced human antibody are polyclonal, meaning they are directed against a variety of different viral antigens and epitopes allowing for a general neutralizing effect against the virus rather than focussing on a specific target. Administration of convalescent plasma has been associated with rapid decrease in viral load. It is also possible that passive immunization contributes to improved cell-mediated immunity by favoring the phagocytosis and presentation of viral antigens to host T cells.

Participant recruitment:Only hospitalized COVID-19 patients are eligible so recruitment efforts will be focused on identified consecutive patients admitted to hospital with acute COVID-19 infection. No other external recruitment efforts are planned. At each participating hospital, a process for identifying patients with COVID-19 will be established.

Donor recruitment for Canadian sites: Recovered COVID-19 patients will be identified as potential donors in collaboration with provincial public health services, local health authorities, and individual co-investigators involved in the study. Potential donors may also be recruiting following self-identification on the routine donor questionnaire or through social media. They will be contacted by phone and invited to participate in the program as potential donors. After obtaining verbal consent and reviewing donor selection criteria, eligible participants will be directed to a Héma-Québec collection or Canadian Blood Services apheresis collection site in their area to donate.

Criteria for donors: All donors will need to meet the criteria set forth in the Manual of donor selection criteria in use at Héma-Québec or Canadian Blood ServicesIn addition, donors will require:

• Prior diagnosis of COVID-19 documented by a PCR test at time of infection or by positive anti-SARS-CoV-2 serology following infection
• Male donors, or female donors with no pregnancy history or with negative anti-HLA antibodies
• At least 6 days since last plasma donation
• Provided informed consent
• A complete resolution of symptoms at least 14 days prior to donation

Donor recruitment for United States sites: Recovered COVID-19 patients are being recruited through the New York Blood Center and Weill Cornell Medicine in separate protocols. Potential donors can self-refer via websites but also be referred by physicians or identified via the medical record system. Only donors with laboratory-confirmed history of COVID-19 will be screened. After providing consent and reviewing FDA and NYBC donor eligibility criteria, donors are screened for the presences of SARS-CoV-2 virus in the nasopharynx if screening within 14 days of complete resolution in accordance with current FDA guidance. Criteria for donation are subject to change based on future revision of FDA guidance. Those found to be eligible will be referred to NYBC for donation.

Criteria for donors:

• Provision of informed consent
• Aged 18 to 70 years. Donors are not longer eligible after their 71st birthday.
• Documented molecular diagnosis of SARS-CoV-2 by RT-PCR by nasopharyngeal swab, oropharyngeal swab, or sputum or detection of anti-SARS-CoV-2 IgG in serum.
• Complete resolution of COVID-19 symptoms at least 14 days prior to donation
• Not currently pregnant or pregnant within 6 weeks by self-report
• Male donors, or females with no pregnancy history or with negative anti-HLA antibodies
• Meets blood donor criteria specified by NYBC, which is consistent with FDA regulations.

Donors will be allowed to donate every 7 days. The following information will be collection from donors: ABO group, sex, age, date of onset of symptoms (when available), date of resolution of symptoms (when available), CCP collection date(s).

Randomization procedures: Patients will be randomized in a 2:1 ratio (convalescent plasma vs standard of care). Patients will be randomized using a secure, concealed, computer-generated, web-accessed randomization sequence. Randomization will be stratified by centre and age (<60 and ≥ 60 years). Within each stratum, variable permuted block sized will be used. This approach will ensure that concealment of the treatment sequence is maintained.

Duration of follow-up: Subjects will be followed daily until hospital discharge or death. Patients discharged from hospital before Day 30 will be contacted by telephone on Day 30 ± 3 days to ascertain any AEs, vital status (dead/alive), hospital readmission and need for mechanical ventilation after discharge. Patients discharged from hospital will be contacted at Day 90+/- 7 days to determine vital status. Patients with a prolonged hospital admission will be censored at Day 90. The local study coordinator will collect all study data and record the data in the electronic CRF or paper CRF as per study procedures for each site.

Duration of study: For an individual subject, the study ends 90 days after randomization. The overall study will end when the last randomized subject has completed 90 day follow-up. We estimate that all patient will be enrolled in a period of 6 months, data on the primary endpoint will be available 30 days after last patient enrollment and data on all secondary endpoints will be available after 90-day from last patient enrollment.

Sample size considerations: Assuming a baseline risk of intubation or death of 30% in hospitalized patients with standard of care, a sample size of 1200 (800 in the convalescent plasma arm, and 400 in the standard of care arm) would provide 80% power to detect a relative risk reduction of 25% with convalescent plasma therapy using a 2-tailed test at level α = 0.05 and a 2:1 randomization.

Interim analysis: A single interim analysis is planned when the primary outcome (intubation or mortality at 30 days) is available for 50% of the target sample. An O'Brien-Fleming stopping rule will be used at that time, but treated as a guideline, so there is minimal impact on the threshold for statistical significance for the final significance test of the primary outcome. A DSMB will monitor ongoing results to ensure patient well-being and safety as well as study integrity. The DSMB will be asked to recommend early termination or modification only when there is clear and substantial evidence of a treatment difference.

Final analysis plan: The primary analysis will be based on the intention-to-treat population which will include data from all individuals who have been randomized. Outcomes will be attributed to the arm to which individuals were randomized irrespective of whether they received the planned intervention (e.g. plasma from a convalescent COVID-19 donor).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 940 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)
• Actual Study Start Date: March 14, 2020
• Actual Primary Completion Date: March 5, 2021
• Actual Study Completion Date: June 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Convalescent plasma; ~500 mL ABO compatible convalescent apheresis plasma	Biological: Convalescent plasma; 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.
No Intervention: Standard of care; Treated as per institutional standard of care.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Were Intubated or Died [ Time Frame: Day 30 ]
   Endpoint of the need for intubation or patient death

Secondary Outcome Measures :

1. Time to Intubation or In-hospital Death [ Time Frame: Day 30 ]
   Time in days from randomization to occurrence of intubation or death
2. Ventilator-free Days by Day 30 [ Time Frame: Day 30 ]
   Number of days off ventilator at 30 days
3. Death by Day 30 [ Time Frame: Day 30 ]
   Occurrence of patient death at 30 days
4. Length of Stay in Intensive Care Unit (ICU) [ Time Frame: Day 30 ]
   Number of days spent in the intensive care unit (ICU) over the 30-day period following randomization
5. Need for Renal Replacement Therapy [ Time Frame: Day 30 ]
   Need for new renal replacement therapy
6. Need for Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: Day 30 ]
   Requirement for extracorporeal membrane oxygenation (ECMO)
7. Development of Myocarditis [ Time Frame: Day 30 ]
   New diagnosis of myocarditis
8. In-hospital Death [ Time Frame: Day 90 ]
   Occurrence of death while in hospital, censored at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.
9. Time to In-hospital Death [ Time Frame: Day 90 ]
   Time to in-hospital death at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.
10. Length of Stay in Hospital [ Time Frame: Day 90 ]
    Number of days from randomization to death or hospital discharge. Patients still in hospital at Day 30 were followed until Day 90 to capture death or discharge from hospital.
11. Number of Participants With Grade 3 and 4 Serious Adverse Events [ Time Frame: Day 30 ]
    Number of participants with Grade 3 and 4 (CTCAE v4.0) serious adverse events, and cumulative incidence of Grade 3 and 4 serious adverse events (using MedDRA AE terms)
12. Number of Participants With CCP Transfusion-associated Adverse Events (AE) [ Time Frame: Day 30 ]
    Number of participants experiencing CCP transfusion-associated adverse events (AE), as defined by the International Society of Blood Tranfusion (ISBT ) classification
13. Number of Participants With Grade 3, 4, or 5 Serious Adverse Events [ Time Frame: Day 30 ]
    Number of Participants with Grade 3-5 (CTCAE v4.0) serious adverse events reported to Day 30
14. Patient Reported Outcome Using Change in EQ-5D-5L Score [ Time Frame: Baseline and Day 30 ]
    Change in score on EQ-5D-5L instrument at Day 30 as compared to baseline. The EQ-5D-5L measures health-related quality of life in five dimensions, namely, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients can report five level impairment, reflecting no, slight, moderate, severe, and extreme problems in each dimension. The range of possible values is -0.148 to 0.949, with a higher score reflecting a better outcome. For the change in score, a positive number indicates that the scores improved from baseline.
15. Patient Reported Outcome- Quality-adjusted Life Days [ Time Frame: Day 30 ]
    Quality-adjusted life days calculated using the EQ-5D-5L score. Quality-adjusted life days is a measure of how well a patient lives for how long. It combines the length of life and quality of life into one value. This is calculated by multiplying the health utility (derived from the EQ-5D-5L score) by the amount of time the patient is alive during the study period. A higher number is better.
16. Cost of Intervention and Hospital Stay [ Time Frame: Day 30 ]
    Cost per patient calculated using cost of the intervention and costs of the hospital stay

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, New York

Brooklyn Hospital

Brooklyn, New York, United States, 11201

Lower Manhattan Hospital

New York, New York, United States, 10038

Weill Cornell Medical Center

New York, New York, United States, 10065

Brazil

Hospital Universitário Antônio Pedro (HUAP)

Niterói, Brazil, 24070-035

Hemario

Rio De Janeiro, Brazil, 20211-030

Canada, Alberta

Peter Lougheed Center

Calgary, Alberta, Canada, T1Y 6J4

Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Rockyview General Hospital

Calgary, Alberta, Canada, T2V 1P9

University of Alberta - Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5H 3V9

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Sturgeon Community Hospital

St. Albert, Alberta, Canada, T8N 6C4

Canada, British Columbia

Fraser Health Authority - Abbotsford Regional Hospital and Cancer Centre

Abbotsford, British Columbia, Canada, V2S 0C2

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

St. Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Royal Jubilee Hospital

Victoria, British Columbia, Canada, V8R 1J8

Victoria General Hospital

Victoria, British Columbia, Canada, V8Z 6R5

Canada, Manitoba

St. Boniface General Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada, R3A 1R9

Grace General Hospital

Winnipeg, Manitoba, Canada, R3J 3M7

Canada, New Brunswick

Vitalité Health Network - Acadie-Bathurst

Bathurst, New Brunswick, Canada, E2A 4L7

Vitalité Health Network - Restigouche

Campbellton, New Brunswick, Canada, E3N 3G2

Vitalité Health Network- Northwest

Edmundston, New Brunswick, Canada, E3V 4E4

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, Canada, E1C 2Z3

Canada, Ontario

Lakeridge Health Ajax Pickering

Ajax, Ontario, Canada, L1S 2J4

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Juravinski Hospital

Hamilton, Ontario, Canada, L8V 1C3

St. Joseph's Healthcare

Hamilton, Ontario, Canada, M6R 1B5

Grand River Hospital

Kitchener, Ontario, Canada, N2G 1G3

St. Mary's Hospital

Kitchener, Ontario, Canada, N2M 1B2

London Health Sciences Centre - University Hospital

London, Ontario, Canada, N6A 5A5

Victoria Hospital

London, Ontario, Canada, N6A 5W9

Markham Stouffville Hospital

Markham, Ontario, Canada, L3P 7P3

Trillium Health Partners - Mississauga Hospital

Mississauga, Ontario, Canada, L5B 1B8

Trillium Health Partners - Credit Valley

Mississauga, Ontario, Canada, L5M 2N1

North York General Hospital

North York, Ontario, Canada, M2K 1E1

Lakeridge Health Oshawa

Oshawa, Ontario, Canada, L1G 2B9

Ottawa Hospital - General Campus

Ottawa, Ontario, Canada, K1H 8L6

Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada, K1Y 4E9

Queensway Carleton Hospital

Ottawa, Ontario, Canada, K2H 8P4

Bluewater Health

Sarnia, Ontario, Canada, N7T 6S3

Scarborough Health Network, Centenary Hospital

Scarborough, Ontario, Canada, M1E 4B9

Scarborough Health Network, General Hospital

Scarborough, Ontario, Canada, M1P 2V5

Scarborough Health Network, Birchmount Hospital

Scarborough, Ontario, Canada, M1W 3W3

Niagara Health System - St. Catherines

St. Catherines, Ontario, Canada, L2S 0A9

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Unity Health St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Sinai Health System

Toronto, Ontario, Canada, M5G 1X5

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Unity Health, St. Joseph's Health Care Centre

Toronto, Ontario, Canada, M6R 1B5

Windsor Regional Hospital - Metropolitan Campus

Windsor, Ontario, Canada, N8W 1L9

Windsor Regional Hospital - Ouellette Campus

Windsor, Ontario, Canada, N9A 1E1

Canada, Quebec

L'Hopital Chicoutimi

Chicoutimi, Quebec, Canada, G7H 5H6

Hôpital de la Cité-de-la-Santé

Laval, Quebec, Canada, H7M 3L9

Hôpital Charles-Le Moyne

Longueuil, Quebec, Canada, J4V 2H1

Hotel Dieu Hospital of Lévis

Lévis, Quebec, Canada, G6V 3Z1

Hôpital Maisonneuve-Rosemont

Montréal, Quebec, Canada, H1T 2M4

Centre hospitalier de l'Université de Montréal

Montréal, Quebec, Canada, H2X 3E4

Montréal General Hospital

Montréal, Quebec, Canada, H3G 1A4

Centre hospitalier universitaire Sainte-Justine

Montréal, Quebec, Canada, H3T 1C5

Jewish General Hospital

Montréal, Quebec, Canada, H3T 1E2

McGill University Health Centre

Montréal, Quebec, Canada, H4A 3J1

Hôpital du Sacré-Coeur de Montreal

Montréal, Quebec, Canada, H4J 1C5

Centre Hospitalier Universitaire (CHU) de Québec - Université Laval

Quebec City, Quebec, Canada, G1R 2J6

Institut Universitaire de cardiologie et pneumologie de Québec

Quebec City, Quebec, Canada, G1V 4G5

Centre hospitalier régional de St-Jérôme

Saint-Jérôme, Quebec, Canada, J7Z 5T3

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

Sherbrooke, Quebec, Canada, J1G 2E8

Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hôpital Fleurimont

Sherbrooke, Quebec, Canada, J1H 5H3

Centre hospitalier affilié universitaire régional de Trois-Rivières

Trois-Rivières, Quebec, Canada, G8Z 3R9

Canada, Saskatchewan

Regina General Hospital

Regina, Saskatchewan, Canada, S4P 0W5

Pasqua Hospital

Regina, Saskatchewan, Canada, S4T 1A5

St. Paul's Hospital

Saskatoon, Saskatchewan, Canada, S7M 0Z9

Royal University Hospital

Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Canadian Blood Services

Héma-Québec

University of Toronto

Université de Montréal

Weill Medical College of Cornell University

New York Blood Center

Investigators

• Principal Investigator: Donald M Arnold, MD; McMaster University

  Study Documents (Full-Text)

Documents provided by McMaster University ( Hamilton Health Sciences Corporation ):

Study Protocol  [PDF] January 15, 2021

Statistical Analysis Plan  [PDF] March 19, 2021

More Information

Additional Information:

Publication of trial results in Nature Medicine 

Publications:

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. Erratum In: Lancet. 2020 Feb 4;:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: Nat Med. 2022 Jan;28(1):212.

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.

• Responsible Party: Hamilton Health Sciences Corporation
• ClinicalTrials.gov Identifier: NCT04348656
• Obsolete Identifiers: NCT04418518
• Other Study ID Numbers: CONCOR-1
• First Posted: April 16, 2020
• Results First Posted: March 3, 2022
• Last Update Posted: March 3, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):

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

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases