A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004285-19-ES
• Lead Sponsor: Fundación para la investigación biomédica del Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-30
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

- = 18 years of age
- Hospitalized for COVID-19*
- Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
- Expected to require hospitalization for > 72 hours

*It is strongly recommended to confirm SARSCoV2 with a positive microbiological test prior to randomization.
At centers where there is delay in confirming the diagnosis, a sufficiently high clinical suspicion is sufficient to proceed with randomization as long as confirmation is expected within 24 hours.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

- Imminent death
- Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
- Pregnancy
- See arm-specific appendices.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified