The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.

• Status: Completed
• Trial end date: 2021-04-26
• Target enrollment: 0
• Participant gender: All

Summary

The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality and/or new requirement for mechanical ventilation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Estudios Clínicos Latino América
• Collaborator: Population Health Research Institute
• Treatments: Colchicine

Criteria

Inclusion Criteria (case definition)

• Consented adults (age ≥18 years) and

• COVID-19 suspicious and

• Admitted to hospital or already in hospital and

• COVID-19 suggestive symptoms (fever or febrile equivalent, loss of smell and taste, fatigue, etc.) that may be present or absent at randomization time and

• SARS (severe acute respiratory syndrome)

• shortness of breath (dyspnea) or

• image of typical or atypical pneumonia or

• oxygen desaturation (SpO2 ≤ 93)

Exclusion criteria

• Clear indication or contraindication for the use of colchicine

• Pregnant or breastfeeding female.

• Chronic renal disease with creatinine clearance <15 ml/min/m2

• Negative PCR test for SARS-COV2