COVID-19 trials registries data warehouse

http://www.isrctn.com/ISRCTN59048638

Dr Alejandro Jose Gonzalez Ochoa

alex8as2@yahoo.com.mx

2020-06-04

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

2

CLINEDEM

40

80

Mexico

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

200

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

Not reported

[{"arm_notes": "Current secondary outcome measures as of 09/09/2020:\n1. Serum levels of D dimer, C-reactive protein, and Creatinine measured by a blood test at baseline and 14 days\n2. Incidence of a thromboembolic event confirmed by ultrasound or CT between baseline and 21 days\n3. Incidence of a major bleeding event between baseline and 21 days", "treatment_id": 1245, "treatment_name": "Sulodexide", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Current secondary outcome measures as of 09/09/2020:\n1. Serum levels of D dimer, C-reactive protein, and Creatinine measured by a blood test at baseline and 14 days\n2. Incidence of a thromboembolic event confirmed by ultrasound or CT between baseline and 21 days\n3. Incidence of a major bleeding event between baseline and 21 days", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]