Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial

Assistance Publique - Hôpitaux de Paris3 sites in 1 country808 target enrollmentApril 20, 2020

ConditionsCOVID19 Pneumonia

InterventionsTinzaparin or unfractionated heparin

DrugsTinzaparin or unfractionated heparin

Overview

Phase: Phase 2
Intervention: Tinzaparin or unfractionated heparin
Conditions: COVID19 Pneumonia
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 808
Locations: 3
Primary Endpoint: ventilator free survival
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent Covid-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19.

This protocol CORIMUNO19-COAG will evaluate the efficacy and safety of active anticoagulation using heparin: Tinzaparin (INNOHEP®) or unfractionated heparin (Calciparine®, Héparine Sodique Choay®) in COVID-19 patients hospitalized in conventional or intensive care units.

It will use a phase 2 randomized open-label multicentre clinical trial, where patients will be randomly allocated to anticoagulation versus Standard of Care.

Registry

clinicaltrials.gov

Start Date

April 20, 2020

End Date

September 30, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•group 1 : patients not requiring ICU at admission with mild disease to severe pneumopathy according to The Who Criteria of severity of COVID pneumopathy, and with symptom onset before 14 days, with need for oxygen but No non-invasive ventilation (NIV) or High flow
•Respiratory failure AND requiring mechanical ventilation
•WHO progression scale ≥ 6
•No do-not-resuscitate order (DNR order)

Exclusion Criteria

•Patients with contraindications to anticoagulation
•Congenital hemorrhagic disorders
•Hypersensitivity to tinzaparin or UHF or to any of the excipients
•Current or history of immune-mediated heparin-induced thrombocytopenia
•Active major haemorrhage or conditions predisposing to major haemorrhage. Major haemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or c) leads to transfusion of 2 or more units of whole blood or red blood cells.
•Septic endocarditis
•Patients with need for anticoagulant therapy. For example: atrial fibrillation, venous thromboembolism, mechanical valve, etc.

Arms & Interventions

Active Coagulation

Intervention: Tinzaparin or unfractionated heparin

Outcomes

Primary Outcomes

ventilator free survival

Time Frame: day 28

group 2

Survival without ventilation (VNI or mechanical ventilation)

Time Frame: day 14

group 1

Secondary Outcomes

overall survival(day 14, 28 and 90)
World Health Organisation(WHO) progression scale ≤5(day 4)
World Health Organisation(WHO) progression scale(day 4, 7 and 14)
Length of hospital stay(day 28)
Length of ICU stay(day 28)
time to ventilator (non invasive or invasive)(day 28)
time to Renal Replacement Therapy (RRT) initiation(day 28)
Rate of clinically overt arterial thrombosis(day 14 and day 90)
Rate of central venous catheter-related deep vein thrombosis (CVC-DVT)(day 28)
time to oxygenation supply independency(day 28)
rate of acute kidney injury(day 28)
rate of clinically overt pulmonary embolism or proximal deep vein thrombosis(day 14 and day 90)
Rate of unscheduled central venous catheter replacement for catheter dysfunction(day 28)
Rate of unscheduled indwelling arterial catheter replacement for catheter dysfunction(day 28)
Rate of acute clotting leading to the replacement the renal replacement therapy circuit stratified by regional citrate anticoagulation or not(day 28)
Time to acute clot formation within the oxygenator (acute oxygenator thrombosis, AOT) leading to the exchange of an extracorporeal membrane oxygenation (ECMO) system(day 28)
Time to acute clot formation within the pump head (pump head thrombosis, PHT) leading to the exchange of an extracorporeal membrane oxygenation (ECMO) system(day 28)
Incidence of adverse events(day 28)