Sulodexide in the treatment of COVID-19
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN59048638
- Lead Sponsor
- CLINEDEM
- Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33677827/ (added 08/03/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 243
Current participant inclusion criteria as of 09/09/2020:
1. Less than 3 days onset of COVID-19 suspected symptoms
2. Age between 40 - 80 years
3. Body mass index between 18 - 35 kg/m²
4. >50% calculated risk for severe clinical progression
Previous participant inclusion criteria:
1. Less than 3 days onset of COVID-19 suspected symptoms
2. Age between 40 - 80 years
3. Body mass index between 18 - 35 kg/m²
4. History of DM, hypertension, CPOD, or other chronic disease
Current participant exclusion criteria as of 09/09/2020:
1. COVID-19 negative test.
2. Reluctant to take medication
3. Reluctant to followup
4. Bed confinement
5. Chronic use of steroids
6. History of deep vein thrombosis in the last 6 months
7. Chronic use of anticoagulation
8. Already in hospital care
9. Previous treatment for COVID-19
Previous participant exclusion criteria:
1. COVID-19 negative test.
2. Reluctant to take medication
3. Reluctant to followup
4. Bed confinement
5. Chronic use of steroids
6. History of deep vein thrombosis in the last 6 months
7. Chronic use of anticoagulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measure as of 09/09/2020:<br> The Clinical-Therapeutic response will be defined as the need for hospitalization, length of stay in hospital (days), need for oxygen support, length of need for oxygen support (days), and death measured using patient records collected between baseline and 21 days<br><br><br> Previous primary outcome measure:<br> The Clinical-Therapeutic response will be defined as the need for hospitalization, presence of thromboembolic complications, length of stay in hospital (days), need for use of mechanical ventilation, need for hemodialysis, major haemorrhagic complications, death measured using patient records throughout the study<br>
- Secondary Outcome Measures
Name Time Method <br> Current secondary outcome measures as of 09/09/2020:<br> 1. Serum levels of D dimer, C-reactive protein, and Creatinine measured by a blood test at baseline and 14 days<br> 2. Incidence of a thromboembolic event confirmed by ultrasound or CT between baseline and 21 days<br> 3. Incidence of a major bleeding event between baseline and 21 days<br><br><br> Previous secondary outcome measures:<br> Levels of D dimmer measured by a blood test in an authorized laboratory site. in group A and B, will be measured at the first visit and at the end of the trial (21 days). Group C will be measured only if positive COVID-19 infection<br>