Trials / Completed
CompletedNCT04527562
Colchicine in Moderate Symptomatic COVID-19 Patients
Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 299 (actual)
- Sponsor
- Dhaka Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-14
- Primary completion
- 2020-11-15
- Completion
- 2020-12-10
- First posted
- 2020-08-26
- Last updated
- 2021-01-11
Locations
1 site across 1 country: Bangladesh
Source: ClinicalTrials.gov record NCT04527562. Inclusion in this directory is not an endorsement.