Colchicine in Moderate Symptomatic COVID-19 Patients (COLCOVIDBD)

Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Colchicine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka-1000, Bangladesh
    • Dhaka Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TRAETMENT GROUP; 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.	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.
PLACEBO_COMPARATOR: CONTROL /PLACEBO GROUP; 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: Isolation facility; Symptomatic treatment with Paracetamol, Fexofenadine; Steam inhalation/Gurgle of Lukewarm water.; Ensuring of hand wash (20 seconds each time) and ideally wearing mask.; Monitoring by the attending nurses.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	14 days following randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dhaka Medical College
• Investigators: Study Chair: Mujibur Rahman, MBBS,MD,FCPS, Professor and Head, Department of Medicine; Principal Investigator: Motlabur Rahman, MBBS, FCPS,FACP, Associate Professor, Department of Medicine

Publications and helpful links

General Publications

• Rahman M, Datta PK, Islam K, Haque M, Mahmud R, Mallik U, Hasan P, Haque M, Faruq I, Sharif M, Ratul RH, Azad KAK, Miah T, Rahman MM. Efficacy of colchicine in patients with moderate COVID-19: A double-blinded, randomized, placebo-controlled trial. PLoS One. 2022 Nov 16;17(11):e0277790. doi: 10.1371/journal.pone.0277790. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 14, 2020
• Primary Completion (ACTUAL): November 15, 2020
• Study Completion (ACTUAL): December 10, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Covid 19; Colchicine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: U1111-1255-3541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No