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Colchicine in Moderate Symptomatic COVID-19 Patients (COLCOVIDBD)

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
Dhaka Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid 19, Colchicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dhaka Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TRAETMENT GROUP

CONTROL /PLACEBO GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of hospital stay
Days from date of enrollment to date of discharge
Number of participant requiring increased amount of supplemental oxygen
Proportion of participants who required oxygen supplementation
Number of participants requiring mechanical ventilation
Proportion of participants who required mechanical ventilation
Number of participants who die
Proportion of participants who die from any cause

Full Information

First Posted
August 25, 2020
Last Updated
January 7, 2021
Sponsor
Dhaka Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04527562
Brief Title
Colchicine in Moderate Symptomatic COVID-19 Patients
Acronym
COLCOVIDBD
Official Title
Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dhaka Medical College

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid 19, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRAETMENT GROUP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CONTROL /PLACEBO GROUP
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
14 days following randomization
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Days from date of enrollment to date of discharge
Time Frame
14 days following randomization
Title
Number of participant requiring increased amount of supplemental oxygen
Description
Proportion of participants who required oxygen supplementation
Time Frame
14 days following randomization
Title
Number of participants requiring mechanical ventilation
Description
Proportion of participants who required mechanical ventilation
Time Frame
14 days following randomization
Title
Number of participants who die
Description
Proportion of participants who die from any cause
Time Frame
14 days following randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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- Fever or history of fever Cough and /or Shortness of breath Oxygen saturation 94% or more Pneumonia -pulmonary consolidations on chest imaging (chest x ray or CT scan of chest) involving less than 50%of lungs 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mujibur Rahman, MBBS,MD,FCPS
Organizational Affiliation
Professor and Head, Department of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Motlabur Rahman, MBBS, FCPS,FACP
Organizational Affiliation
Associate Professor, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Medical College Hospital
City
Dhaka-1000
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36383611
Citation
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.
Results Reference
derived

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Colchicine in Moderate Symptomatic COVID-19 Patients

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