Trial Evaluating Efficacy and Safety of Anticoagulation in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort

COVID19 Pneumonia Clinical Trial

— CORIMMUNO-COAG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04344756
• Other study ID #: APHP200389-6
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 20, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Tristan Mirault
• Phone: 1 56 09 50 41
• Email: tristan.mirault[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 808
• Est. completion date: September 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. group 2 :

• Respiratory failure AND requiring mechanical ventilation

• WHO progression scale = 6

• No do-not-resuscitate order (DNR order)

Exclusion Criteria:

• Patients with contraindications to anticoagulation

1. Congenital hemorrhagic disorders

2. Hypersensitivity to tinzaparin or UHF or to any of the excipients

3. Current or history of immune-mediated heparin-induced thrombocytopenia

4. 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.

5. Septic endocarditis

• Patients with need for anticoagulant therapy. For example: atrial fibrillation, venous thromboembolism, mechanical valve, etc.

Related Conditions & MeSH terms

• COVID19 Pneumonia
• Pneumonia

Intervention

Drug:
• Tinzaparin or unfractionated heparin
Tinzaparin INNOHEP ® 175 IU/kg/24h for 14 days if creatinine clearance Cockcroft = 20mL/min, Otherwise unfractionated heparin (Calciparine®, Héparine Sodique Choay®) subcutaneously or intravenous with an anti-Xa target between 0.5 and 0.7 IU/mL for 14 days

Locations

Country	Name	City	State
France	Réanimation hôpital Louis Mourier	Colombes	Hauts De Seine
France	Médecine vasculaire, Hôpital Européen Georges Pompidou	Paris
France	réanimation hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without ventilation (VNI or mechanical ventilation)	group 1	day 14
Primary	ventilator free survival	group 2	day 28
Secondary	World Health Organisation(WHO) progression scale =5	range from 0 (healthy) to 10 (death) values below or equal to 5 correspond to the absence of any oxygen supply beside nasal or facial mask	day 4
Secondary	World Health Organisation(WHO) progression scale	range from 0 (healthy) to 10 (death)	day 4, 7 and 14
Secondary	overall survival		day 14, 28 and 90
Secondary	Length of hospital stay		day 28
Secondary	Length of ICU stay		day 28
Secondary	time to oxygenation supply independency		day 28
Secondary	time to ventilator (non invasive or invasive)		day 28
Secondary	rate of acute kidney injury	according to Acute Kidney Injury (AKIN) classification system	day 28
Secondary	time to Renal Replacement Therapy (RRT) initiation		day 28
Secondary	rate of clinically overt pulmonary embolism or proximal deep vein thrombosis	confirmed by objective testing	day 14 and day 90
Secondary	Rate of clinically overt arterial thrombosis	confirmed by objective testing	day 14 and day 90
Secondary	Rate of unscheduled central venous catheter replacement for catheter dysfunction		day 28
Secondary	Rate of central venous catheter-related deep vein thrombosis (CVC-DVT)	as a thrombus extending from the catheter into the lumen of the deep vein where the catheter is inserted diagnosed with radiologic imaging in case of a clinical suspicion of upper/lower limb DVT or pulmonary embolism or compulsory catheter removal	day 28
Secondary	Rate of unscheduled indwelling arterial catheter replacement for catheter dysfunction		day 28
Secondary	Rate of acute clotting leading to the replacement the renal replacement therapy circuit stratified by regional citrate anticoagulation or not		day 28
Secondary	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
Secondary	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
Secondary	Incidence of adverse events		day 28