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.
Drug: Colchicine
Participants in this group will be given a starting dose of 1.2 mg of Colchicine (2 tablets of 0.6 mg )single or 12 hourly divided dose. After that, they will take colchicine 0.6mg daily for 13 days. If they develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. Supportive care and treatment will also be given.
Drug: Placebo
Participants in this group will be given a starting dose of 2 tablets of Placebo, single or 12 hourly divided dose. After that, they will take one placebo tablet daily for 13 days.Placebo tablet will be identical with the Colchicine tablet. If patients develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. Supportive care and treatment will also be given.
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.
Dhaka Medical College Hospital
Dhaka-1000, Bangladesh