NCT04492358

Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Maria Joyera Rodríguez · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine: ideal dose of 0.3 mg/kg/day (or the dose that approximates that adjusted for age, weight and kidney function, and 0.5 mg and 1 mg tablets)
DRUG	Prednisone tablet	Prednisone 60 mg/day, in a single dose, during 3 days
DRUG	standard of care	The standard treatment used in each site will be administered to the patients assigned to the control group.

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-07-30
• Last updated: 2023-02-21

Locations

3 sites across 1 country: Spain