COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Current interventions as of 09/09/2020:
Group A: patients with COVID-19 early symptoms to received mask placebo 500LRU twice a day +
standard of care.
a collaborating physician will be followed to the study under physical home or virtual visit (cell, computer, telephone) every 7 days for a period of 21 days as available, making records of any sympt
in case of admission to hospital, information is requested from your treating physician about its evolution until its release, prior authorization by the patient.
Previous interventio
Group B: patients with COVID-19 early symptoms to received Sulodexide 250 RLU bid + conventional treatment
Group C: high risk of infection to received sulodexide 250 RLU
will receive placebo on the same packaging as your original sulodexide, a collaborating physician will be followed to the study u
Sponsors
CLINEDEM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/09/2020: 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 Previous primary outcome measure: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/09/2020: 1. Serum levels of D dimer, C-reactive protein, and Creatinine measured by a blood test at baseline and 14 days 2. Incidence of a thromboembolic event confirmed by ultrasound or CT between baseline and 21 days 3. Incidence of a major bleeding event between baseline and 21 days Previous secondary outcome measures: 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 | — |
Countries
Mexico
Outcome results
None listed