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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344756
Recruitment Status : Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
COVID19 Pneumonia Drug: Tinzaparin or unfractionated heparin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial with 2 parallels arms, 1:1, stratified on disease severity (ventilation or not)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Active Coagulation 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

No Intervention: Standard of Care
Control patients will receive the best standard of care and a subcutaneous preventive anticoagulation for at least 14 days with enoxaparin 4000 IU/24h, tinzaparin 3500 IU/24h or dalteparin 5000 IU/24h if creatinine clearance (Cockcroft) ≥ 30mL/min or unfractionated heparin 5000 IU/12h if creatinine clearance < 30mL/min.



Primary Outcome Measures :
  1. Survival without ventilation (VNI or mechanical ventilation) [ Time Frame: day 14 ]
    group 1

  2. ventilator free survival [ Time Frame: day 28 ]
    group 2


Secondary Outcome Measures :
  1. World Health Organisation(WHO) progression scale ≤5 [ Time Frame: 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

  2. World Health Organisation(WHO) progression scale [ Time Frame: day 4, 7 and 14 ]
    range from 0 (healthy) to 10 (death)

  3. overall survival [ Time Frame: day 14, 28 and 90 ]
  4. Length of hospital stay [ Time Frame: day 28 ]
  5. Length of ICU stay [ Time Frame: day 28 ]
  6. time to oxygenation supply independency [ Time Frame: day 28 ]
  7. time to ventilator (non invasive or invasive) [ Time Frame: day 28 ]
  8. rate of acute kidney injury [ Time Frame: day 28 ]
    according to Acute Kidney Injury (AKIN) classification system

  9. time to Renal Replacement Therapy (RRT) initiation [ Time Frame: day 28 ]
  10. rate of clinically overt pulmonary embolism or proximal deep vein thrombosis [ Time Frame: day 14 and day 90 ]
    confirmed by objective testing

  11. Rate of clinically overt arterial thrombosis [ Time Frame: day 14 and day 90 ]
    confirmed by objective testing

  12. Rate of unscheduled central venous catheter replacement for catheter dysfunction [ Time Frame: day 28 ]
  13. Rate of central venous catheter-related deep vein thrombosis (CVC-DVT) [ Time Frame: 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

  14. Rate of unscheduled indwelling arterial catheter replacement for catheter dysfunction [ Time Frame: day 28 ]
  15. Rate of acute clotting leading to the replacement the renal replacement therapy circuit stratified by regional citrate anticoagulation or not [ Time Frame: day 28 ]
  16. Time to acute clot formation within the oxygenator (acute oxygenator thrombosis, AOT) leading to the exchange of an extracorporeal membrane oxygenation (ECMO) system [ Time Frame: day 28 ]
  17. Time to acute clot formation within the pump head (pump head thrombosis, PHT) leading to the exchange of an extracorporeal membrane oxygenation (ECMO) system [ Time Frame: day 28 ]
  18. Incidence of adverse events [ Time Frame: day 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT04344756


Contacts
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Contact: Tristan Mirault 1 56 09 50 41 ext 33 tristan.mirault@aphp.fr
Contact: Jean-Luc Diehl jean-luc.diehl@aphp.fr

Locations
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France
Réanimation hôpital Louis Mourier
Colombes, Hauts De Seine, France, 92701
Contact: Damien Roux, MD PhD    1 47 60 61 62 ext 33    damien.roux@aphp.fr   
réanimation hôpital Cochin
Paris, France, 75014
Contact: Frédéric Penne, MD PhD    1 58 41 25 27 ext 33      
Médecine vasculaire, Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04344756    
Other Study ID Numbers: APHP200389-6
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anticoagulants
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heparin
Calcium heparin
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action