COVIDPhase 3COVID-19 HDNCT04408235
High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy
A Phase 3 study testing Enoxaparin in people with COVID and Pneumonia, Viral, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation. Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID, Pneumonia, Viral, Coagulation Disorder
- What is being tested?
- Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2020to Jun 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)
- Severe pneumonia defined by the presence of at least one of the following criteria:
- Respiratory Rate ≥25 breaths /min
- Arterial oxygen saturation≤93% at rest on ambient air
- PaO2/FiO2 ≤300 mmHg
- Coagulopathy, defined by the presence of at least one of the following criteria:
Show all 9Show fewer
- D-dimer >4 times the upper level of normal reference range
- Sepsis-Induced Coagulopathy (SIC) score >4
- No need for invasive mechanical ventilation
Who cannot join
- Invasive mechanical ventilation
- Thrombocytopenia (platelet count < 80.000 mm3)
- Coagulopathy: INR >1.5, aPTT ratio > 1.4
- Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation < 30 ml/min)
- Known hypersensitivity to enoxaparin
- History of heparin induced thrombocytopenia
Show all 13Show fewer
- Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant cancer at high risk of haemorrhage, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
- Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves).
- Concomitant double antiplatelet therapy
- Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed
- Pregnancy or breastfeeding or positive pregnancy test
- Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition)
- Lack or withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero-Universitaria
Modena, 41124
Pasquale Mighali, 0594225868 ext. +39, mighali.pasquale@policlinico.mo.it
Marco Marietta, MD
About this study
Official title: Randomised Controlled Trial Comparing High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy Not Requiring Invasive Mechanical Ventilation
Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.
Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are:
- More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:
- Death
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation
- Similar in terms of major bleeding risk during hospital stay
Read the detailed description
This is a multicentre, randomised controlled, open label, investigator sponsored, two arms study.
The study will involve 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Diseases Units, 1 Respiratory Diseases Unit.
Patients who satisfy all inclusion criteria and do not have any exclusion criteria and have signed written informed consent, will be randomly assigned to a Low-Dose LMWH group (Control Group) or High-Dose LMWH group (Intervention Group) in a 1:1 ratio.
Control Group (Low-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at standard prophylactic dose (i.e., 4000 IU subcutaneously once day).
Intervention Group (High-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at dose of 70 IU/kg every 12 hours, as reported in the following table.
The study is conceived as open-label: patients and all health-care personnel involved in the study will be aware of the assigned group.
The treatments will be initiated as soon as possible after randomization (maximum allowed starting time 12h after randomization).
Patients allocated to the two arms will maintain the doses of Enoxaparin, as stated in the protocol, until:
- hospital discharge or
- when at least one of the following events occurs:
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
- Major bleeding
- Any adverse events and clinical condition requiring interruption of the scheduled intervention according to the judgement of the physician in charge
- Death
The decision about what type and dose of antithrombotic treatment to administer, after the interruption of assigned dose of Enoxaparin, will be left to clinical judgement of the physicians in charge.
Any information about the type and dose of antithrombotic treatments administered after the interruption of the assigned dose of Enoxaparin will be collected until the hospital discharge or death.
Each patient will be followed-up until hospital discharge. Information about the status (dead/alive) of patients who are discharged from hospital before 30 days will be sought on Day 30 from randomisation.
- Conditions
- COVID, Pneumonia, Viral, Coagulation Disorder
- Being tested
- Enoxaparin
- Keywords
- COVID-19, PNEUMONIA, COAGULOPATHY, LOW-MOLECULAR WEIGHT HEPARIN, ENOXAPARIN
- Medical subject headings
- Pneumonia, Viral, Hemostatic Disorders, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Inhixa®
Low-Dose LMWH: enoxaparin 4000 IU daily; High dose LMWH: 70 IU/kg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose LMWH | Active comparator | Enoxaparin 4000 IU daily Receives: Drug: Enoxaparin |
| High-Dose LMWH | Experimental | Enoxaparin 70 IU/kg twice daily Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:
- Death
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
Measured: through study completion, up to 30 days
Secondary outcomes (2)
Any of the following events occurring within the hospital stay
- Death
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
- Improvement of laboratory parameters of disease severity, including:
- D-dimer level
- Plasma fibrinogen levels
- Mean Platelet Volume
- Lymphocyte/Neutrophil ratio
- IL-6 plasma levels
Measured: through study completion, up to 30 days
Mortality at 30 days
Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentre, randomised controlled, open label, investigator sponsored, two arms study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Marietta, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Marco Marietta, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408235
- Sponsor's protocol ID
- EudraCT N°: 2020-001972-13
- Acronym
- COVID-19 HD
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524Leisman DE, Deutschman CS, Legrand M. Facing COVID-19 in the ICU: vascular dysfunction, thrombosis, and dysregulated inflammation. Intensive Care Med. 2020 Jun;46(6):1105-1108. doi: 10.1007/s00134-020-06059-6. Epub 2020 Apr 28. No abstract available.
PubMed 32347323Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.
PubMed 32220112Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
PubMed 32073213Marietta M, Ageno W, Artoni A, De Candia E, Gresele P, Marchetti M, Marcucci R, Tripodi A. COVID-19 and haemostasis: a position paper from Italian Society on Thrombosis and Haemostasis (SISET). Blood Transfus. 2020 May;18(3):167-169. doi: 10.2450/2020.0083-20. Epub 2020 Apr 8. No abstract available.
PubMed 32281926Thachil J, Tang N, Gando S, Falanga A, Cattaneo M, Levi M, Clark C, Iba T. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026. doi: 10.1111/jth.14810. Epub 2020 Apr 27. No abstract available.
PubMed 32338827Thachil J. The versatile heparin in COVID-19. J Thromb Haemost. 2020 May;18(5):1020-1022. doi: 10.1111/jth.14821. Epub 2020 Apr 27. No abstract available.
PubMed 32239799Wu MA, Del GIovane C, Colombo R, Dolci G, Arquati M, Vicini R, Russo U, Ruggiero D, Coluccio V, Taino A, Franceschini E, Facchinetti P, Mighali P, Trombetta L, Tonelli F, Gabiati C, Cogliati C, D'Amico R, Marietta M; ETHYCO Study Group. Low-molecular-weight heparin for the prevention of clinical worsening in severe non-critically ill COVID-19 patients: a joint analysis of two randomized controlled trials. Intern Emerg Med. 2024 Jan;19(1):71-79. doi: 10.1007/s11739-023-03439-w. Epub 2023 Oct 4.
PubMed 37794281Flumignan 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 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy Not Requiring Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04408235
- Acronym / sponsor ID
- COVID-19 HD / EudraCT N°: 2020-001972-13
- Conditions
- COVID, Pneumonia, Viral, Coagulation Disorder
- Keywords
- COVID-19, PNEUMONIA, COAGULOPATHY, LOW-MOLECULAR WEIGHT HEPARIN, ENOXAPARIN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 May 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.
Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.
Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are:
- More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:
- Death
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation
- Similar in terms of major bleeding risk during hospital stay
Detailed description
This is a multicentre, randomised controlled, open label, investigator sponsored, two arms study.
The study will involve 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Diseases Units, 1 Respiratory Diseases Unit.
Patients who satisfy all inclusion criteria and do not have any exclusion criteria and have signed written informed consent, will be randomly assigned to a Low-Dose LMWH group (Control Group) or High-Dose LMWH group (Intervention Group) in a 1:1 ratio.
Control Group (Low-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at standard prophylactic dose (i.e., 4000 IU subcutaneously once day).
Intervention Group (High-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at dose of 70 IU/kg every 12 hours, as reported in the following table.
The study is conceived as open-label: patients and all health-care personnel involved in the study will be aware of the assigned group.
The treatments will be initiated as soon as possible after randomization (maximum allowed starting time 12h after randomization).
Patients allocated to the two arms will maintain the doses of Enoxaparin, as stated in the protocol, until:
- hospital discharge or
- when at least one of the following events occurs:
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
- Major bleeding
- Any adverse events and clinical condition requiring interruption of the scheduled intervention according to the judgement of the physician in charge
- Death
The decision about what type and dose of antithrombotic treatment to administer, after the interruption of assigned dose of Enoxaparin, will be left to clinical judgement of the physicians in charge.
Any information about the type and dose of antithrombotic treatments administered after the interruption of the assigned dose of Enoxaparin will be collected until the hospital discharge or death.
Each patient will be followed-up until hospital discharge. Information about the status (dead/alive) of patients who are discharged from hospital before 30 days will be sought on Day 30 from randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a multicentre, randomised controlled, open label, investigator sponsored, two arms study.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose LMWH | Active comparator | Drug: EnoxaparinEnoxaparin 4000 IU daily |
| High-Dose LMWH | Experimental | Drug: EnoxaparinEnoxaparin 70 IU/kg twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)
- Severe pneumonia defined by the presence of at least one of the following criteria:
- Coagulopathy, defined by the presence of at least one of the following criteria:
- No need for invasive mechanical ventilation
Key exclusion criteria (13 listed)
- Invasive mechanical ventilation
- Thrombocytopenia (platelet count < 80.000 mm3)
- Coagulopathy: INR >1.5, aPTT ratio > 1.4
- Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation < 30 ml/min)
- Known hypersensitivity to enoxaparin
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 |
|---|---|---|
| EnoxaparinAlso: Inhixa®Low-Dose LMWH: enoxaparin 4000 IU daily; High dose LMWH: 70 IU/kg twice daily | Drug | High-Dose LMWH, Low-Dose LMWH |
Primary outcome
Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:
Time frame: through study completion, up to 30 days
1. Death 2. Acute Myocardial Infarction [AMI] 3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] 4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation 5. Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
2 secondary outcomes
Any of the following events occurring within the hospital stay
Time frame: through study completion, up to 30 days
Mortality at 30 days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Background: PubMed 32167524Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
- Background: PubMed 32347323Leisman DE, Deutschman CS, Legrand M. Facing COVID-19 in the ICU: vascular dysfunction, thrombosis, and dysregulated inflammation. Intensive Care Med. 2020 Jun;46(6):1105-1108. doi: 10.1007/s00134-020-06059-6. Epub 2020 Apr 28. No abstract available.
- Background: PubMed 32220112Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.
- Background: PubMed 32073213Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
- Background: PubMed 32281926Marietta M, Ageno W, Artoni A, De Candia E, Gresele P, Marchetti M, Marcucci R, Tripodi A. COVID-19 and haemostasis: a position paper from Italian Society on Thrombosis and Haemostasis (SISET). Blood Transfus. 2020 May;18(3):167-169. doi: 10.2450/2020.0083-20. Epub 2020 Apr 8. No abstract available.
- Background: PubMed 32338827Thachil J, Tang N, Gando S, Falanga A, Cattaneo M, Levi M, Clark C, Iba T. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026. doi: 10.1111/jth.14810. Epub 2020 Apr 27. No abstract available.
- Background: PubMed 32239799Thachil J. The versatile heparin in COVID-19. J Thromb Haemost. 2020 May;18(5):1020-1022. doi: 10.1111/jth.14821. Epub 2020 Apr 27. No abstract available.
- Derived from this study: PubMed 37794281Wu MA, Del GIovane C, Colombo R, Dolci G, Arquati M, Vicini R, Russo U, Ruggiero D, Coluccio V, Taino A, Franceschini E, Facchinetti P, Mighali P, Trombetta L, Tonelli F, Gabiati C, Cogliati C, D'Amico R, Marietta M; ETHYCO Study Group. Low-molecular-weight heparin for the prevention of clinical worsening in severe non-critically ill COVID-19 patients: a joint analysis of two randomized controlled trials. Intern Emerg Med. 2024 Jan;19(1):71-79. doi: 10.1007/s11739-023-03439-w. Epub 2023 Oct 4.
- 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.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Marco Marietta, MD principal investigator
Azienda Ospedaliero-Universitaria di Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin in people with COVID and Pneumonia, Viral, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 9 inclusion and 13 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 29 May 2020. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Marco Marietta, MD (0594224640 ext. +39, marco.marietta@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: (time frame: through study completion, up to 30 days). 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 NCT04408235, which also lists 10 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 29 May 2020.