This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days
Introduction: COVID-19 and mortality associated with acute respiratory distress syndrome
(ARDS) pose a global public health problem. The increase in spread and associated mortality
poses a scenario where cost-effective therapeutic options are urgently and effectively
proposed to control and reduce the pandemic and even to reduce the number of deaths
Objective: To evaluate the efficacy and safety of oral colchicine plus treatment standard
versus standard treatment in the clinical course of SARS-CoV-2 virus infection, in a
population group with moderate COVID-19 involvement and requiring hospitalization.
Methodology: A prospective, open, randomized, parallel-group study, the sample size of 120
subjects each arm of 60 subjects. Random assignment (1: 1) to either colchicine plus standard
treatment or control arm (standard treatment) orally for 14 days. An initial dose of 1.5 mg
orally on the first day, followed by 0.5 mg every 12 hours on days 2 to 7 and continuing with
0.5 mg a day until completing 14 days ± 1. It will be followed on days 1, 3, 7, 14, and day
28, evaluating physical examination, clinical situation, laboratories, and adverse events.
The primary efficacy data correspond to the deterioration in the clinical status of the
patients through the semiquantitative ordinal scale suggested by the WHO R&D committee.
Expected results: It is expected to find out how, through different pathways, colchicine
could act in modulating or preventing the appearance of ARDS associated with COVID-19, its
possible effects on viral replication and antigenic presentation.
Drug: Colchicine 0.5 MG
Patientes in this arm will receive study medication colchicine 1,5 orally on the first day (initially two pills of 0,5 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator.
Other Name: EXPOSED GROUP
Combination Product: CONTROL GROUP
In this case, the centers where the patients are enrolled will adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases)
Other Name: standard treatment
Inclusion Criteria:
- Patients ≥18 years old.
- Laboratory-confirmed SARS-CoV-2 infection: infection confirmed with nasopharyngeal
swab by positive RT PCR in the last 48 hours.
- Hospital admission for COVID-19 in the previous 48 hours.
- Clinical stage 3 (no supplemental oxygen requirement) or 4 (supplemental oxygen
requirement for nasal contact lenses or mask) of the WHO classification (see ANNEX 2).
- The patient must be able and willing to provide informed written consent before
performing study procedures.
- Patient confirmed to covid19 as positive by positive PCR test
Exclusion Criteria:
- Pregnancy, nursing mothers, and women of childbearing potential who are unable to use
adequate contraception.
- Known hypersensitivity or other clear contraindication to the use of colchicine.
- History of end-stage renal disease (eGFR <30 ml / min / 1.73 m2).
- Medical history of cirrhosis (Child-Pugh C), liver failure, chronic active hepatitis,
or severe liver disease defined by alanine aminotransferase (ALT) or aspartate
aminotransferase (AST)> 5 times the upper limit of normal.
- History of pre-existing neuromuscular disease.
- Previous severe hematologic disease or bleeding disorders.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea,
or malabsorptive syndrome.
- Colchicine treatment for other indications.
- Treatment with immunosuppressive/immunomodulatory agents, including glucocorticoids,
antivirals, antimalarials, and IL 6 antagonists for 30 days prior to enrollment.
- Use of other investigational drugs at the time of inclusion, or during the 30 days
prior to inclusion.
- Any medical condition or disease that, in the opinion of the investigator, may place
the patient at unacceptable risk to participate in the study.
Fundación Universitaria de Ciencias de La Salud
Bogota, Cundinamarca, Colombia
JHON JAIME SPROCKEL, MD; IM, Study Chair
Hospital de San Jose