Colchicine in Moderate Symptomatic COVID-19 Patients (COLCOVIDBD)

• ClinicalTrials.gov Identifier: NCT04527562
• Recruitment Status: Completed
• First Posted: August 26, 2020
• Last Update Posted: January 11, 2021
• Sponsor: Dhaka Medical College
• Information provided by (Responsible Party): Dr. Md. Motlabur Rahman, Dhaka Medical College

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Drug: Colchicine; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 299 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy
• Actual Study Start Date: July 14, 2020
• Actual Primary Completion Date: November 15, 2020
• Actual Study Completion Date: December 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 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 :

1. Length of hospital stay [ Time Frame: 14 days following randomization ]
   Days from date of enrollment to date of discharge
2. Number of participant requiring increased amount of supplemental oxygen [ Time Frame: 14 days following randomization ]
   Proportion of participants who required oxygen supplementation
3. Number of participants requiring mechanical ventilation [ Time Frame: 14 days following randomization ]
   Proportion of participants who required mechanical ventilation
4. Number of participants who die [ Time Frame: 14 days following randomization ]
   Proportion of participants who die from any cause

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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-

  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.

Contacts and Locations

Locations

Bangladesh

Dhaka Medical College Hospital

Dhaka-1000, Bangladesh

Sponsors and Collaborators

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

More Information

• Responsible Party: Dr. Md. Motlabur Rahman, Associate Professor, Department of Medicine, Dhaka Medical College
• ClinicalTrials.gov Identifier: NCT04527562
• Other Study ID Numbers: U1111-1255-3541
• First Posted: August 26, 2020
• Last Update Posted: January 11, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Dr. Md. Motlabur Rahman, Dhaka Medical College:

Covid 19; Colchicine

Additional relevant MeSH terms:

Colchicine; Gout Suppressants; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents