COVID19 PneumoniaPhase 2CORIMMUNO-COAGNCT04344756
Trial Evaluating Efficacy and Safety of Anticoagulation in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
A Phase 2 study testing Tinzaparin or unfractionated heparin in people with COVID19 Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19 Pneumonia
- What is being tested?
- Tinzaparin or unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Apr 2020to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Jean-Luc Diehl contact
France3 sites
Réanimation hôpital Louis Mourier
Colombes, Hauts De Seine, 92701
Damien Roux, MD PhD, 1 47 60 61 62 ext. 33, damien.roux@aphp.fr
réanimation hôpital Cochin
Paris, 75014
Frédéric Penne, MD PhD, 1 58 41 25 27 ext. 33
Médecine vasculaire, Hôpital Européen Georges Pompidou
Paris, 75015
About this study
Official title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial
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
- Being tested
- Tinzaparin or unfractionated heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinzaparin or unfractionated heparinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Active Coagulation | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without ventilation (VNI or mechanical ventilation)
group 1
Measured: day 14
ventilator free survival
group 2
Measured: day 28
Secondary outcomes (18)
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
Measured: day 4
World Health Organisation(WHO) progression scale
range from 0 (healthy) to 10 (death)
Measured: day 4, 7 and 14
overall survival
Measured: day 14, 28 and 90
Length of hospital stay
Measured: day 28
Length of ICU stay
Measured: day 28
time to oxygenation supply independency
Measured: day 28
time to ventilator (non invasive or invasive)
Measured: day 28
rate of acute kidney injury
according to Acute Kidney Injury (AKIN) classification system
Measured: day 28
time to Renal Replacement Therapy (RRT) initiation
Measured: day 28
rate of clinically overt pulmonary embolism or proximal deep vein thrombosis
confirmed by objective testing
Measured: day 14 and day 90
Rate of clinically overt arterial thrombosis
confirmed by objective testing
Measured: day 14 and day 90
Rate of unscheduled central venous catheter replacement for catheter dysfunction
Measured: day 28
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
Measured: day 28
Rate of unscheduled indwelling arterial catheter replacement for catheter dysfunction
Measured: day 28
Rate of acute clotting leading to the replacement the renal replacement therapy circuit stratified by regional citrate anticoagulation or not
Measured: 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
Measured: 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
Measured: day 28
Incidence of adverse events
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with 2 parallels arms, 1:1, stratified on disease severity (ventilation or not)
- Masking
- None (open label)
- Enrolment
- 808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344756
- Sponsor's protocol ID
- APHP200389-6
- Acronym
- CORIMMUNO-COAG
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Flumignan 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.
PubMed 33502773
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial
- ClinicalTrials.gov ID
- NCT04344756
- Acronym / sponsor ID
- CORIMMUNO-COAG / APHP200389-6
- Conditions
- COVID19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 808 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial with 2 parallels arms, 1:1, stratified on disease severity (ventilation or not)
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 :
Key exclusion criteria (7 listed)
- Patients with contraindications to anticoagulation
- Patients with need for anticoagulant therapy. For example: atrial fibrillation, venous thromboembolism, mechanical valve, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinzaparin or unfractionated heparinTinzaparin 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 | Drug | Active Coagulation |
Primary outcome
Survival without ventilation (VNI or mechanical ventilation)
Time frame: day 14
group 1
ventilator free survival
Time frame: day 28
group 2
18 secondary outcomes
World Health Organisation(WHO) progression scale ≤5
Time frame: day 4
World Health Organisation(WHO) progression scale
Time frame: day 4, 7 and 14
overall survival
Time frame: day 14, 28 and 90
Length of hospital stay
Time frame: day 28
Length of ICU stay
Time frame: day 28
time to oxygenation supply independency
Time frame: day 28
time to ventilator (non invasive or invasive)
Time frame: day 28
rate of acute kidney injury
Time frame: day 28
time to Renal Replacement Therapy (RRT) initiation
Time frame: day 28
rate of clinically overt pulmonary embolism or proximal deep vein thrombosis
Time frame: day 14 and day 90
Rate of clinically overt arterial thrombosis
Time frame: day 14 and day 90
Rate of unscheduled central venous catheter replacement for catheter dysfunction
Time frame: day 28
Rate of central venous catheter-related deep vein thrombosis (CVC-DVT)
Time frame: day 28
Rate of unscheduled indwelling arterial catheter replacement for catheter dysfunction
Time frame: day 28
Rate of acute clotting leading to the replacement the renal replacement therapy circuit stratified by regional citrate anticoagulation or not
Time frame: 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
Time frame: 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
Time frame: day 28
Incidence of adverse events
Time frame: day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 35244208Flumignan 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33502773Flumignan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Diehl contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tinzaparin or unfractionated heparin in people with COVID19 Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tristan Mirault (1 56 09 50 41 ext. 33, tristan.mirault@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without ventilation (VNI or mechanical ventilation) (time frame: day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.