Status:
COMPLETED
The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.
Lead Sponsor:
Estudios Clínicos Latino América
Collaborating Sponsors:
Population Health Research Institute
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mor...
Detailed Description
Various anti-viral treatments are being tested in clinical trials worldwide. The World Health Organization (WHO) launched a simple,pragmatic worldwide open-label trial to test Remdesivir, Lopinavir/Ri...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
1279 Patients enrolled
Trial Details
Trial ID
NCT04328480
Start Date
April 17 2020
End Date
April 26 2021
Last Update
April 27 2021
Active Locations (1)
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1
Sanatorio Parque
Rosario, Santa Fe Province, Argentina, 2000