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Colchicine in Moderate Symptomatic COVID-19 Patients

NCT04527562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2021-01-11

No results posted yet for this study

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

  • Covid19

Interventions

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.

Sponsors & Collaborators

  • Dhaka Medical College

    lead OTHER

Principal Investigators

  • Mujibur Rahman, MBBS,MD,FCPS · Professor and Head, Department of Medicine

  • Motlabur Rahman, MBBS, FCPS,FACP · Associate Professor, Department of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2020-11-15
Completion
2020-12-10

Countries

  • Bangladesh

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527562 on ClinicalTrials.gov