Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
Study NCT ID:
NCT04408235
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2020-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-19 HD
Brief 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. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are:
1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:
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. Similar in terms of major bleeding risk during hospital stay
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:
1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:
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. 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:
1. hospital discharge or
2. when at least one of the following events occurs:
1. Acute Myocardial Infarction \[AMI\]
2. Objectively confirmed, symptomatic arterial or venous thromboembolism \[TE\]
3. 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
4. Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
5. Major bleeding
6. Any adverse events and clinical condition requiring interruption of the scheduled intervention according to the judgement of the physician in charge
7. 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.
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:
1. hospital discharge or
2. when at least one of the following events occurs:
1. Acute Myocardial Infarction \[AMI\]
2. Objectively confirmed, symptomatic arterial or venous thromboembolism \[TE\]
3. 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
4. Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
5. Major bleeding
6. Any adverse events and clinical condition requiring interruption of the scheduled intervention according to the judgement of the physician in charge
7. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: