CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1) (CONCOR-1)
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|ClinicalTrials.gov Identifier: NCT04348656|
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : June 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||May 14, 2020|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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.
- Intubation or death in hospital [ Time Frame: Day 30 ]Endpoint of the need for intubation or patient death in hospital
- Need for Intubation [ Time Frame: Day 30 ]Endpoint of the need for intubation before 30 days
- Time to intubation [ Time Frame: Day 30 ]Time in hours to intubation from randomization
- Ventilator-free days [ Time Frame: Day 30 ]Endpoint of the number of days off ventilator at 30 days
- In-hospital death [ Time Frame: 90 days ]In-hospital death censored at 90 days
- Time to in-hospital death [ Time Frame: Day 90 ]Time to in-hospital death at 90 days
- Death at 30 days [ Time Frame: 30 days ]Death at 30 days
- Length of stay in intensive care unit (ICU) [ Time Frame: Day 30 ]Date of intensive care unit admission (first date and total number of days)
- Length of stay in hospital [ Time Frame: Day 30 ]Date of hospital admission (first date and total number of days)
- Need for extracorpeal membrane oxygenation (ECMO) [ Time Frame: Day 30 ]First date on ECMO and total number of days
- Need for renal replacement therapy [ Time Frame: Day 30 ]Need for renal replacement therapy
- Development of myocarditis [ Time Frame: Day 30 ]New myocarditis
- Adverse events and serious adverse events [ Time Frame: Day 30 ]Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)
- CCP transfusion-associated adverse events (AE) [ Time Frame: 30 days ]CCP transfusion-associated adverse events (AE)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348656
|Contact: Donald M Arnold, MD||9055259140 ext firstname.lastname@example.org|
|Contact: Erin B Jamula, MSc.||9055259140 ext email@example.com|
|Principal Investigator:||Donald M Arnold, MD||McMaster University|