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

A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: Convalescent plasma

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 Type: Interventional
• Enrollment (Actual): 940
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Niterói, Brazil, 24070-035
    • Hospital Universitário Antônio Pedro (HUAP)
  • Rio De Janeiro, Brazil, 20211-030
    • Hemario
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Lougheed Center
    • Calgary, Alberta, Canada, T2V 1P9
      • Rockyview General Hospital
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T5H 3V9
      • University of Alberta - Royal Alexandra Hospital
    • St. Albert, Alberta, Canada, T8N 6C4
      • Sturgeon Community Hospital
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • Fraser Health Authority - Abbotsford Regional Hospital and Cancer Centre
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Victoria, British Columbia, Canada, V8R 1J8
      • Royal Jubilee Hospital
    • Victoria, British Columbia, Canada, V8Z 6R5
      • Victoria General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre Winnipeg
    • Winnipeg, Manitoba, Canada, R3J 3M7
      • Grace General Hospital
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4L7
      • Vitalité Health Network - Acadie-Bathurst
    • Campbellton, New Brunswick, Canada, E3N 3G2
      • Vitalité Health Network - Restigouche
    • Edmundston, New Brunswick, Canada, E3V 4E4
      • Vitalité Health Network- Northwest
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr. Georges-L.-Dumont University Hospital Centre
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J4
      • Lakeridge Health Ajax Pickering
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Hospital
    • Hamilton, Ontario, Canada, M6R 1B5
      • St. Joseph's Healthcare
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Hospital
    • Kitchener, Ontario, Canada, N2M 1B2
      • St. Mary's Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
    • London, Ontario, Canada, N6A 5W9
      • Victoria Hospital
    • Markham, Ontario, Canada, L3P 7P3
      • Markham Stouffville Hospital
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Partners - Mississauga Hospital
    • Mississauga, Ontario, Canada, L5M 2N1
      • Trillium Health Partners - Credit Valley
    • North York, Ontario, Canada, M2K 1E1
      • North York General Hospital
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital - General Campus
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital - Civic Campus
    • Ottawa, Ontario, Canada, K2H 8P4
      • Queensway Carleton Hospital
    • Sarnia, Ontario, Canada, N7T 6S3
      • Bluewater Health
    • Scarborough, Ontario, Canada, M1E 4B9
      • Scarborough Health Network, Centenary Hospital
    • Scarborough, Ontario, Canada, M1P 2V5
      • Scarborough Health Network, General Hospital
    • Scarborough, Ontario, Canada, M1W 3W3
      • Scarborough Health Network, Birchmount Hospital
    • St. Catherines, Ontario, Canada, L2S 0A9
      • Niagara Health System - St. Catherines
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Sinai Health System
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health St. Michael's Hospital
    • Toronto, Ontario, Canada, M6R 1B5
      • Unity Health, St. Joseph's Health Care Centre
    • Windsor, Ontario, Canada, N8W 1L9
      • Windsor Regional Hospital - Metropolitan Campus
    • Windsor, Ontario, Canada, N9A 1E1
      • Windsor Regional Hospital - Ouellette Campus
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • L'Hopital Chicoutimi
    • Laval, Quebec, Canada, H7M 3L9
      • Hôpital de la Cité-de-la-Santé
    • Longueuil, Quebec, Canada, J4V 2H1
      • Hôpital Charles-Le Moyne
    • Lévis, Quebec, Canada, G6V 3Z1
      • Hotel Dieu Hospital of Lévis
    • Montréal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Universite de Montreal
    • Montréal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montréal
    • Montréal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montréal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
    • Montréal, Quebec, Canada, H3T 1C5
      • Centre Hospitalier Universitaire Sainte-Justine
    • Montréal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Quebec City, Quebec, Canada, G1R 2J6
      • Centre Hospitalier Universitaire (CHU) de Québec - Université Laval
    • Quebec City, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et Pneumologie de Québec
    • Saint-Jérôme, Quebec, Canada, J7Z 5T3
      • Centre hospitalier régional de St-Jérôme
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hôpital Hôtel-Dieu
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Centre hospitalier affilié universitaire régional de Trois-Rivières
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Regina General Hospital
    • Regina, Saskatchewan, Canada, S4T 1A5
      • Pasqua Hospital
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
    • Saskatoon, Saskatchewan, Canada, S7M 0Z9
      • St. Paul's Hospital
• United States
  • New York
    • Brooklyn, New York, United States, 11201
      • Brooklyn Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
    • New York, New York, United States, 10038
      • Lower Manhattan Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were Intubated or Died	Endpoint of the need for intubation or patient death	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Intubation or In-hospital Death	Time in days from randomization to occurrence of intubation or death	Day 30
Ventilator-free Days by Day 30	Number of days off ventilator at 30 days	Day 30
Death by Day 30	Occurrence of patient death at 30 days	Day 30
Length of Stay in Intensive Care Unit (ICU)	Number of days spent in the intensive care unit (ICU) over the 30-day period following randomization	Day 30
Need for Renal Replacement Therapy	Need for new renal replacement therapy	Day 30
Need for Extracorporeal Membrane Oxygenation (ECMO)	Requirement for extracorporeal membrane oxygenation (ECMO)	Day 30
Development of Myocarditis	New diagnosis of myocarditis	Day 30
In-hospital Death	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.	Day 90
Time to In-hospital Death	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.	Day 90
Length of Stay in Hospital	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.	Day 90
Number of Participants With Grade 3 and 4 Serious Adverse Events	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)	Day 30
Number of Participants With CCP Transfusion-associated Adverse Events (AE)	Number of participants experiencing CCP transfusion-associated adverse events (AE), as defined by the International Society of Blood Tranfusion (ISBT ) classification	Day 30
Number of Participants With Grade 3, 4, or 5 Serious Adverse Events	Number of Participants with Grade 3-5 (CTCAE v4.0) serious adverse events reported to Day 30	Day 30
Patient Reported Outcome Using Change in EQ-5D-5L Score	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.	Baseline and Day 30
Patient Reported Outcome- Quality-adjusted Life Days	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.	Day 30
Cost of Intervention and Hospital Stay	Cost per patient calculated using cost of the intervention and costs of the hospital stay	Day 30

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.

Helpful Links

• Publication of trial results in Nature Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2020
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Transfusion; Convalescent plasma; Passive immunization
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CONCOR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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