Status:
COMPLETED
Colchicine in Moderate Symptomatic COVID-19 Patients
Lead Sponsor:
Dhaka Medical College
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, double blind, randomized, placebo controlled clinical trial. The participants will be randomized into two groups (group A and group B). Patients of group-A are the treatment gro...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Males and females of least 18 years of age and can swallow tablets
- Competent and willing to provide informed consent
- Patient must have received a diagnosis of COVID-19 infection with positive RT-PCR for SARS CoV-2 within the last 3 days
- Patients with moderate symptoms (According to National Guidelines on Clinical Management of Coronavirus Disease 2019 (COVID- 19).Version 7.0 .2020, DGHS, MOHFW, Government of the People's Republic of Bangladesh). Following features of moderate covid-19 must be present-
- Fever or history of fever
- Cough and /or Shortness of breath
- Oxygen saturation 94% or more
- Pneumonia -pulmonary consolidations on chest imaging (chest x ray or CT scan of chest) involving less than 50%of lungs
- CRB 65 score 0
- Exclusion criteria:
- Pregnancy and breast-feeding
- Known hypersensitivity to colchicine
- Known chronic illness e.g hepatic failure, chronic kidney disease (eGFR\<30ml/min), decompensated heart failure, long QT syndrome (QTc \>450 msec.)
- Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption
- Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout)
- Patient undergoing chemotherapy for cancer
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Exclusion
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2020
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT04527562
Start Date
July 14 2020
End Date
December 10 2020
Last Update
January 11 2021
Active Locations (1)
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1
Dhaka Medical College Hospital
Dhaka-1000, Bangladesh