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 Terminated 54 enrolled Maria Joyera Rodríguez

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2020-10-22
Primary completion: 2021-05-31
Completion: 2021-05-31

Outcome

Missed primary endpoint

Stopped (Enrollment): “No candidates for the recruitment”

paper At day 28, no differences in deaths were observed. PMID 36173596 ↗

paper risk difference (RD) of - 17% (p = 0.17), with an average reduction of 39% (risk ratio [RR] 0.61) in patients receiving colchicine/prednisone (p = 0.25). PMID 36173596 ↗

Publications

Hernandez-Rodriguez J, Duran-Sanclemente J, Prieto-Gonzalez S, Araujo O, Hospital-Vidal T, Casanovas G, Sapena V, Blanco JL, Lopez-Soto A; FRAGILE-COLCOVID19 Study Group. FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities. Clin Drug Investig. 2022 Nov;42(11):949-964. doi: 10.1007/s40261-022-01201-2. Epub 2022 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colchicine	Small molecule	0.5 mg	Oral
Subject	Prednisone	Other / unclassified	60 mg	Oral