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

Phase 2

• Conditions: COVID19 Pneumonia
• Interventions: Drug: Tinzaparin or unfractionated heparin

• Registration Number: NCT04344756
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-12
• Study First Posted: 2020-04-14
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15
• Study Start: 2020-04-20
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 808

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Coagulation	Tinzaparin or unfractionated heparin	-

Primary Outcome Measures

Name	Time	Method
ventilator free survival	day 28	group 2
Survival without ventilation (VNI or mechanical ventilation)	day 14	group 1

Secondary Outcome Measures

Name	Time	Method
World Health Organisation(WHO) progression scale ≤5	day 4	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
World Health Organisation(WHO) progression scale	day 4, 7 and 14	range from 0 (healthy) to 10 (death)
overall survival	day 14, 28 and 90
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	confirmed by objective testing
Rate of central venous catheter-related deep vein thrombosis (CVC-DVT)	day 28	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
time to oxygenation supply independency	day 28
rate of acute kidney injury	day 28	according to Acute Kidney Injury (AKIN) classification system
rate of clinically overt pulmonary embolism or proximal deep vein thrombosis	day 14 and day 90	confirmed by objective testing
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

Trial Locations

Locations (3)

Médecine vasculaire, Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Réanimation hôpital Louis Mourier; 🇫🇷 Colombes, Hauts De Seine, France

réanimation hôpital Cochin; 🇫🇷 Paris, France