Colchicine in Moderate Symptomatic COVID-19 Patients

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Colchicine

• Registration Number: NCT04527562
• Lead Sponsor: Dhaka Medical College

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-14
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL /PLACEBO GROUP	Placebo	COVID-19 Patients in this arm will receive standard COVID-19 treatment according to national guidelines of Bangladesh and will receive placebo. Standard care of enrolled study patients will consist: 1. Isolation facility 2. Symptomatic treatment with Paracetamol, Fexofenadine 3. Steam inhalation/Gurgle of Lukewarm water. 4. Ensuring of hand wash (20 seconds each time) and ideally wearing mask. 5. Monitoring by the attending nurses.
TRAETMENT GROUP	Colchicine	Participants in the colchicine treatment 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.

Primary Outcome Measures

Name	Time	Method
Time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a Seven-category ordinal scale.	14 days following randomization	Seven-category ordinal scale. The scale is recommended by the WHO R\&D Blueprint expert group. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	14 days following randomization	Days from date of enrollment to date of discharge
Number of participants requiring mechanical ventilation	14 days following randomization	Proportion of participants who required mechanical ventilation
Number of participants who die	14 days following randomization	Proportion of participants who die from any cause
Number of participant requiring increased amount of supplemental oxygen	14 days following randomization	Proportion of participants who required oxygen supplementation

Trial Locations

Locations (1)

Dhaka Medical College Hospital; 🇧🇩 Dhaka-1000, Bangladesh