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NCT Number: NCT04527562

Colchicine in Moderate Symptomatic COVID-19 Patients

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhaka Medical College Hospital

Dhaka-1000, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colchicine

Drug

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

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dhaka Medical College

Other

Registry information

Official study title

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

Acronym: COLCOVIDBD

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2020
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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