Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

August 18, 2020

Primary Completion Date

March 20, 2021

Study Completion Date

June 30, 2021

Conditions
COVID-19
Interventions
DRUG

Emtricitabine/tenofovir

Generic drug distributed by the Colombian Health System for Human Immunodeficiency Virus (HIV) positive patients It is classified as an anti infectious drug and its current indications include HIV infections.

DRUG

Colchicine Pill

Generic drug distributed by the Colombian Health System as an insurance treatment for Gout. It has been suggested that colchicine would be useful in SARS Covid 19 becouse its antiinflammatory effects through reduction of cytokine levels as well as the activation of macrophages, neutrophils, and the inflammasome

DRUG

Rosuvastatin

Generic drug distribute by the Colombian Health System. It is used in people with High levels of cholesterol. An action against the main protease (Mpro) of COVID 19 virus has been described, There is evidence suggesting that statins could exert anti Covid 19 action and the infectivity of enveloped viruses

OTHER

Standard treatment

Standard treatment n, multiple organ failure related to the acute infection including respiratory support (oxygen, positive end-expiration pressure with external devices or invasive ventilatory support), cardiovascular, renal, haematological or coagulation, or co-infection with bacterial or mycotic organisms, standard care to prevent pressure ulcers or other care required by the patient. No viral therapies are included.

Trial Locations (6)

110111

Clinica santa Maria del lago, Bogotá

110121

Clínica Reina Sofía, Bogotá

110131

Fundacion Cardio Infantil, Bogotá

110231

Hospital Universitario San Ignacio, Bogotá

111321

Clinica Universitaria Colombia, Bogotá

Hospital Universitario Nacional de Colombia, Bogotá

All Listed Sponsors
collaborator

Pontificia Universidad Javeriana

OTHER

collaborator

Clínica Colsanitas-Clínica Universitaria Colombia

UNKNOWN

collaborator

Hospital Universitario San Ignacio

OTHER

collaborator

Hospital Universitario Nacional de Colombia (HUN)

UNKNOWN

collaborator

Fundación Cardioinfantil Instituto de Cardiología

OTHER

collaborator

Clínica Infantil Santa María del Lago

UNKNOWN

lead

Universidad Nacional de Colombia

OTHER

NCT04359095 - Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia | Biotech Hunter | Biotech Hunter