Severe COVID-19 PneumoniaPhase 2ANTICOVIDNCT04808882
ANTIcoagulation in Severe COVID-19 Patients
A Phase 2 study testing Tinzaparin, Low dose prophylactic anticoagulation, Tinzaparin, High dose prophylactic anticoagulation and Tinzaparin,Therapeutic anticoagulation in people with Severe COVID-19 Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a state of profound inflammation, platelet activation, and endothelial dysfunction leading to respiratory distress and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe COVID-19 Pneumonia
- What is being tested?
- Tinzaparin, Low dose prophylactic anticoagulation, Tinzaparin, High dose prophylactic anticoagulation and Tinzaparin,Therapeutic anticoagulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2021to 13 Mar 2022
- 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
- Age ≥ 18 years ;
- Severe COVID-19 pneumonia, defined by:
- A newly-appeared pulmonary parenchymal infiltrate; AND
- a positive RT-PCR (either upper or lower respiratory tract) for COVID-19 (SARS-CoV-2); AND
- WHO progression scale ≥ 5 (on The Who ordinal scale)
- Written informed consent (patient, next of skin or emergency situation).
- In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.
Who cannot join
- Pregnancy and breast feeding woman;
- Postpartum (6 weeks);
- Extreme weights (<40 kg or >100 kg);
- Patients admitted since more than 72 hours to the hospital (if the WHO ordinal scale is 5 at time of inclusion) or since more than 72 hours to the intensive care unit (if the WHO ordinal scale is 6 or more at time of inclusion);
- Need for therapeutic anticoagulation (except for COVID-related pulmonary thrombosis);
- Bleeding event related to hemostasis disorders, acute clinically significant bleed, current gastrointestinal ulcer or any organic lesion with high risk for bleeding
Show all 18Show fewer
- Platelet count < 50 G/L;
- Within 15 days of recent surgery, within 24 hours of spinal or epidural anesthesia;
- Any prior intracranial hemorrhage, enlarged acute ischemic stroke, known intracranial malformation or neoplasm, acute infectious endocarditis;
- Severe renal failure (creatinine clearance <30 mL/min);
- Iodine allergy;
- Hypersensitivity to heparin or its derivatives including low-molecular-weight heparin;
- History of type II heparin-induced thrombocytopenia;
- Chronic oxygen supplementation;
- Moribund patient or death expected from underlying disease during the current admission;
- Patient deprived of liberty and persons subject to institutional psychiatric care;
- Patients under guardianship or curatorship;
- Participation to another interventional research on anticoagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a state of profound inflammation, platelet activation, and endothelial dysfunction leading to respiratory distress and increased mortality. The incidence of macrovascular thrombotic events varies from 10 to 30% in COVID-19 hospitalized patients depending on the type of arterial or vein thrombosis captured and severity of illness . Observational results in patients receiving routine low-dose prophylactic anticoagulation (LD-PA), several institutions have recently released guidance statement to prevent macrovascular thrombotic events with dose escalation anticoagulation. In these recommendations, high-dose prophylactic anticoagulation (HD-PA) and therapeutic anticoagulation (TA) can be employed either empirically or based on the body mass index and increased D-dimer values. No randomized trial has validated this approach, and other recent recommendations challenge this approach. Microvascular thrombotic events are also of major concern in critically ill patients with COVID-19, even in the absence of obvious macrovascular thrombotic events. A large review of autopsy findings in COVID-19-related deaths reported micro thrombi in small pulmonary vessels. More generally, COVID-19-induced endothelitis and coagulopathy across vascular beds of different organs lead to widespread microvascular thrombosis with microangiopathy and occlusion of capillaries. Thus, in severe COVID-19 patients requiring oxygen therapy without initial macrovascular thrombotic event, a HD-PA or a TA could be beneficial by limiting the extension of microvascular thrombosis and the evolution of the lung and multi-organ microcirculatory dysfunction. In a large observational cohort of 2,773 COVID-19 patients, a lower in-hospital mortality in ventilated patients receiving TA as compared to those receiving PA (29.1% vs. 62.7%). Our hypothesis is dual: i) first, that TA and HD-PA strategies mitigate microthrombosis and each limit the progression of COVID-19, including respiratory failure and multi-organ dysfunction, with in fine a decreased mortality and duration of disease, as compared to a low-dose PA; ii) second, that TA outperforms HD-PA in this setting.
- Conditions
- Severe COVID-19 Pneumonia
- Being tested
- Tinzaparin, Low dose prophylactic anticoagulation, Tinzaparin, High dose prophylactic anticoagulation, Tinzaparin,Therapeutic anticoagulation
- Keywords
- COVID-19, Anticoagulation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinzaparin, Low dose prophylactic anticoagulationDrug
Also called LD-PA
Participants randomized to the LD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: LD-PA : 3500 IU/24h. Depending on the type of tinzaparin pre-filled syringe available in the participating center, the dose of 4000 IU/24h will be allowed in place of 3500 IU/24h.
If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: LD-PA: 4000 IU/24h.
After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.
Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data.
Tinzaparin, High dose prophylactic anticoagulationDrug
Also called HD-PA
Participants randomized to the HD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: HD-PA : 7000 IU/24h.
If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: HD-PA: 4000 IU/12h.
After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.
Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data.
Tinzaparin,Therapeutic anticoagulationDrug
Also called TA
Participants randomized to the TA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: TA : 175 IU/kg/24h.
If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: TA: 100 IU/kg/12h.
After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.
Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data.
| Study group | Role | What they receive |
|---|---|---|
| Low dose prophylactic anticoagulation | Experimental | LD-PA Receives: Drug: Tinzaparin, Low dose prophylactic anticoagulation |
| High dose prophylactic anticoagulation | Experimental | HD-PA Receives: Drug: Tinzaparin, High dose prophylactic anticoagulation |
| Therapeutic anticoagulation | Experimental | TA Receives: Drug: Tinzaparin,Therapeutic anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Day-28
Number of days to clinical improvement
Clinical improvement will be assessed through a seven-category ordinal scale derived from the WHO scale, using the following categories: 1. not hospitalized with resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7. death. As all included patients will at least require oxygen supplementation, live discharge from hospital will represent a minimal 2-points decrease in the 7-points scale, thus a clinical improvement.
Measured: Day-28
Secondary outcomes (19)
Net clinical benefit of anticoagulation assessed by the absence of thrombotic event, major bleeding event, Heparin Induced Thrombocytopenia and all-cause death
Measured: Day-28
All-cause deaths
Measured: Day-28 and Day-90
Proportion of patients with at least one thrombotic event at Day-28
Measured: Day-28
Proportion of patients with at least one major bleeding event (MBE) at Day-28
Measured: Day-28
Proportion of patients with at least one life-threatening bleeding event at Day-28
Measured: Day-28
Proportion of patients with any bleeding event at Day-28
Measured: Day-28
Proportion of patients with Heparin Induced Thrombocytopenia at Day-28
Measured: Day-28
Number of days to clinical improvement assessed through a seven-category ordinal scale derived from the WHO scale
Measured: Day-28
Score on the seven-category ordinal scale derived from the WHO Ordinal scale
Measured: Day-28
Score on WHO Ordinal Scale
Measured: Day-28
Number of days alive and free from supplemental oxygen at Day-28
Measured: Day-28
Proportion of patients needing intubation at Day-28
Measured: Day-28
Number of days alive and free from invasive mechanical ventilation at Day-28
Measured: Day-28
Number of days alive and free from vasopressors at Day-28
Measured: Day-28
Length of intensive care unit stay
Measured: Day-28
Length of hospital stay
Measured: Day-28
Quality of life and disability at assessed using a quality of life questionnaire
Measured: Day-90
D-dimers levels
Measured: Day-7
Sepsis-Induced Coagulopathy Score (SCS)
Measured: Day-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start14 Apr 2021
- Primary completion10 Jan 2022
- Study completion13 Mar 2022
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 Severe COVID-19 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
- The research is a multicenter, parallel group, open-label, randomized controlled superiority trial, aiming at comparing three usual strategies of anticoagulation. The primary hierarchical criterion assessed at Day-28, includes all-cause mortality followed by the time to clinical improvement. The three strategies are LD-PA, HD-PA, and TA, with a 1:1:1 ratio
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LABBE, MD, Study director, Assistance Publique Hopitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808882
- Sponsor's protocol ID
- APHP201624
- Other IDs
- 2020-A03531-38
- Acronym
- ANTICOVID
- Status last verified
- Dec 2020
- First submitted
- 8 Mar 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Labbe V, Contou D, Heming N, Megarbane B, Razazi K, Boissier F, Ait-Oufella H, Turpin M, Carreira S, Robert A, Monchi M, Souweine B, Preau S, Doyen D, Vivier E, Zucman N, Dres M, Fejjal M, Noel-Savina E, Bachir M, Jaffal K, Timsit JF, Picos SA, Mariotte E, Martis N, Juguet W, Melica G, Rondeau P, Audureau E, Mekontso Dessap A; ANTICOVID Investigators. Effects of Standard-Dose Prophylactic, High-Dose Prophylactic, and Therapeutic Anticoagulation in Patients With Hypoxemic COVID-19 Pneumonia: The ANTICOVID Randomized Clinical Trial. JAMA Intern Med. 2023 Jun 1;183(6):520-531. doi: 10.1001/jamainternmed.2023.0456.
PubMed 36946232Labbe V, Contou D, Heming N, Megarbane B, Ait-Oufella H, Boissier F, Carreira S, Robert A, Vivier E, Fejjal M, Doyen D, Monchi M, Preau S, Noel-Savina E, Souweine B, Zucman N, Picos SA, Dres M, Juguet W, Mariotte E, Timsit JF, Turpin M, Razazi K, Gendreau S, Baloul S, Voiriot G, Fartoukh M, Audureau E, Mekontso Dessap A. Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial. BMJ Open. 2022 Apr 26;12(4):e059383. doi: 10.1136/bmjopen-2021-059383.
PubMed 35473740
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04808882
- Acronym / sponsor ID
- ANTICOVID / APHP201624
- Conditions
- Severe COVID-19 Pneumonia
- Keywords
- COVID-19, Anticoagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 22 Mar 2021 (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.
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a state of profound inflammation, platelet activation, and endothelial dysfunction leading to respiratory distress and increased mortality. The incidence of macrovascular thrombotic events varies from 10 to 30% in COVID-19 hospitalized patients depending on the type of arterial or vein thrombosis captured and severity of illness . Observational results in patients receiving routine low-dose prophylactic anticoagulation (LD-PA), several institutions have recently released guidance statement to prevent macrovascular thrombotic events with dose escalation anticoagulation. In these recommendations, high-dose prophylactic anticoagulation (HD-PA) and therapeutic anticoagulation (TA) can be employed either empirically or based on the body mass index and increased D-dimer values. No randomized trial has validated this approach, and other recent recommendations challenge this approach. Microvascular thrombotic events are also of major concern in critically ill patients with COVID-19, even in the absence of obvious macrovascular thrombotic events. A large review of autopsy findings in COVID-19-related deaths reported micro thrombi in small pulmonary vessels. More generally, COVID-19-induced endothelitis and coagulopathy across vascular beds of different organs lead to widespread microvascular thrombosis with microangiopathy and occlusion of capillaries. Thus, in severe COVID-19 patients requiring oxygen therapy without initial macrovascular thrombotic event, a HD-PA or a TA could be beneficial by limiting the extension of microvascular thrombosis and the evolution of the lung and multi-organ microcirculatory dysfunction. In a large observational cohort of 2,773 COVID-19 patients, a lower in-hospital mortality in ventilated patients receiving TA as compared to those receiving PA (29.1% vs. 62.7%). Our hypothesis is dual: i) first, that TA and HD-PA strategies mitigate microthrombosis and each limit the progression of COVID-19, including respiratory failure and multi-organ dysfunction, with in fine a decreased mortality and duration of disease, as compared to a low-dose PA; ii) second, that TA outperforms HD-PA in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The research is a multicenter, parallel group, open-label, randomized controlled superiority trial, aiming at comparing three usual strategies of anticoagulation. The primary hierarchical criterion assessed at Day-28, includes all-cause mortality followed by the time to clinical improvement. The three strategies are LD-PA, HD-PA, and TA, with a 1:1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Low dose prophylactic anticoagulation | Experimental | Drug: Tinzaparin, Low dose prophylactic anticoagulationLD-PA |
| High dose prophylactic anticoagulation | Experimental | Drug: Tinzaparin, High dose prophylactic anticoagulationHD-PA |
| Therapeutic anticoagulation | Experimental | Drug: Tinzaparin,Therapeutic anticoagulationTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years ;
- Severe COVID-19 pneumonia, defined by:
- Written informed consent (patient, next of skin or emergency situation).
- In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.
Key exclusion criteria (18 listed)
- Pregnancy and breast feeding woman;
- Postpartum (6 weeks);
- Extreme weights (<40 kg or >100 kg);
- Patients admitted since more than 72 hours to the hospital (if the WHO ordinal scale is 5 at time of inclusion) or since more than 72 hours to the intensive care unit (if the WHO ordinal scale is 6 or more at time of inclusion);
- Need for therapeutic anticoagulation (except for COVID-related pulmonary thrombosis);
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, Low dose prophylactic anticoagulationAlso: LD-PAParticipants randomized to the LD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: LD-PA : 3500 IU/24h. Depending on the type of tinzaparin pre-filled syringe available in the participating center, the dose of 4000 IU/24h will be allowed in place of 3500 IU/24h. If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: LD-PA: 4000 IU/24h. After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians. Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data. | Drug | Low dose prophylactic anticoagulation |
| Tinzaparin, High dose prophylactic anticoagulationAlso: HD-PAParticipants randomized to the HD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: HD-PA : 7000 IU/24h. If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: HD-PA: 4000 IU/12h. After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians. Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data. | Drug | High dose prophylactic anticoagulation |
| Tinzaparin,Therapeutic anticoagulationAlso: TAParticipants randomized to the TA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: TA : 175 IU/kg/24h. If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: TA: 100 IU/kg/12h. After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians. Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data. | Drug | Therapeutic anticoagulation |
Primary outcome
All-cause mortality
Time frame: Day-28
Number of days to clinical improvement
Time frame: Day-28
Clinical improvement will be assessed through a seven-category ordinal scale derived from the WHO scale, using the following categories: 1. not hospitalized with resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7. death. As all included patients will at least require oxygen supplementation, live discharge from hospital will represent a minimal 2-points decrease in the 7-points scale, thus a clinical improvement.
19 secondary outcomes
Net clinical benefit of anticoagulation assessed by the absence of thrombotic event, major bleeding event, Heparin Induced Thrombocytopenia and all-cause death
Time frame: Day-28
All-cause deaths
Time frame: Day-28 and Day-90
Proportion of patients with at least one thrombotic event at Day-28
Time frame: Day-28
Proportion of patients with at least one major bleeding event (MBE) at Day-28
Time frame: Day-28
Proportion of patients with at least one life-threatening bleeding event at Day-28
Time frame: Day-28
Proportion of patients with any bleeding event at Day-28
Time frame: Day-28
Proportion of patients with Heparin Induced Thrombocytopenia at Day-28
Time frame: Day-28
Number of days to clinical improvement assessed through a seven-category ordinal scale derived from the WHO scale
Time frame: Day-28
Score on the seven-category ordinal scale derived from the WHO Ordinal scale
Time frame: Day-28
Score on WHO Ordinal Scale
Time frame: Day-28
Number of days alive and free from supplemental oxygen at Day-28
Time frame: Day-28
Proportion of patients needing intubation at Day-28
Time frame: Day-28
Number of days alive and free from invasive mechanical ventilation at Day-28
Time frame: Day-28
Number of days alive and free from vasopressors at Day-28
Time frame: Day-28
Length of intensive care unit stay
Time frame: Day-28
Length of hospital stay
Time frame: Day-28
Quality of life and disability at assessed using a quality of life questionnaire
Time frame: Day-90
D-dimers levels
Time frame: Day-7
Sepsis-Induced Coagulopathy Score (SCS)
Time frame: Day-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Derived from this study: PubMed 36946232Labbe V, Contou D, Heming N, Megarbane B, Razazi K, Boissier F, Ait-Oufella H, Turpin M, Carreira S, Robert A, Monchi M, Souweine B, Preau S, Doyen D, Vivier E, Zucman N, Dres M, Fejjal M, Noel-Savina E, Bachir M, Jaffal K, Timsit JF, Picos SA, Mariotte E, Martis N, Juguet W, Melica G, Rondeau P, Audureau E, Mekontso Dessap A; ANTICOVID Investigators. Effects of Standard-Dose Prophylactic, High-Dose Prophylactic, and Therapeutic Anticoagulation in Patients With Hypoxemic COVID-19 Pneumonia: The ANTICOVID Randomized Clinical Trial. JAMA Intern Med. 2023 Jun 1;183(6):520-531. doi: 10.1001/jamainternmed.2023.0456.
- Derived from this study: PubMed 35473740Labbe V, Contou D, Heming N, Megarbane B, Ait-Oufella H, Boissier F, Carreira S, Robert A, Vivier E, Fejjal M, Doyen D, Monchi M, Preau S, Noel-Savina E, Souweine B, Zucman N, Picos SA, Dres M, Juguet W, Mariotte E, Timsit JF, Turpin M, Razazi K, Gendreau S, Baloul S, Voiriot G, Fartoukh M, Audureau E, Mekontso Dessap A. Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial. BMJ Open. 2022 Apr 26;12(4):e059383. doi: 10.1136/bmjopen-2021-059383.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Vincent LABBE, MD study director
Assistance Publique Hopitaux de Paris (AP-HP)
1 site 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, Low dose prophylactic anticoagulation, Tinzaparin, High dose prophylactic anticoagulation and Tinzaparin,Therapeutic anticoagulation in people with Severe COVID-19 Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Day-28). 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 NCT04808882, 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 8 Sep 2022; AzTrials last refreshed its copy on 4 Nov 2026.