Colchicine in Moderate Symptomatic COVID-19 Patients

• Status: Completed
• Trial end date: 2020-12-10
• Target enrollment: 0
• Participant gender: All

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 group. They will be treated with optimal treatment based on the algorithm proposed in National Guidelines on Clinical Management of Coronavirus Disease 2019 (Covid-19) Version 7.0, 28 May 2020, along with Colchicine for 14 days. The patients in group-B will be controlled group. They will be treated with optimal treatment based on the algorithm proposed in National Guideline along with a placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dhaka Medical College
• Treatments: Colchicine

Criteria

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-

1. Fever or history of fever

2. Cough and /or Shortness of breath

3. Oxygen saturation 94% or more

4. Pneumonia -pulmonary consolidations on chest imaging (chest x ray or CT scan of chest) involving less than 50%of lungs

5. 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.