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

NCT04344756 | Unknown Phase 2 DMC

• 1 other identifier: APHP200389-6
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID19 Pneumonia

Outcome Measures

Primary Outcomes (2)

• Survival without ventilation (VNI or mechanical ventilation)

  group 1

  day 14

• ventilator free survival

  group 2

  day 28

Secondary Outcomes (18)

• World Health Organisation(WHO) progression scale ≤5

  day 4

• World Health Organisation(WHO) progression scale

  day 4, 7 and 14

• overall survival

  day 14, 28 and 90

• Length of hospital stay

  day 28

• Length of ICU stay

  day 28

Study Arms (2)

Active Coagulation

EXPERIMENTAL

Drug: Tinzaparin or unfractionated heparin

Standard of Care

NO INTERVENTION

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.

Interventions

Tinzaparin or unfractionated heparin DRUG

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

Active Coagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• group 2 :
• Respiratory failure AND requiring mechanical ventilation
• WHO progression scale ≥ 6
• No do-not-resuscitate order (DNR order)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Réanimation hôpital Louis Mourier

Colombes, Hauts De Seine, 92701, France

Location

réanimation hôpital Cochin

Paris, 75014, France

Location

Médecine vasculaire, Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (2)

• Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

  PMID: 35244208 DERIVED

• Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.

  PMID: 33502773 DERIVED

MeSH Terms

Interventions

Tinzaparin; Heparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Tristan Mirault

CONTACT

1 56 09 50 41; tristan.mirault@aphp.fr

Jean-Luc Diehl

CONTACT

jean-luc.diehl@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial with 2 parallels arms, 1:1, stratified on disease severity (ventilation or not)

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: April 20, 2020
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

FR (3)