Clinical trial NCT04527562: Colchicine in Moderate Symptomatic COVID-19 Patients
Official title: Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Covid 19
Colchicine
Lead sponsor: Dhaka Medical College
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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-

  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.

Primary outcomes:
measure: 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.
timeFrame: 14 days following randomization
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 14 days following randomization
measure: Number of participant requiring increased amount of supplemental oxygen
timeFrame: 14 days following randomization
measure: Number of participants requiring mechanical ventilation
timeFrame: 14 days following randomization
measure: Number of participants who die
timeFrame: 14 days following randomization
Other outcomes:
Locations:
city: Dhaka-1000
country: Bangladesh
facility: Dhaka Medical College Hospital
Study officials:
affiliation: Professor and Head, Department of Medicine
name: Mujibur Rahman, MBBS,MD,FCPS
role: STUDY_CHAIR
affiliation: Associate Professor, Department of Medicine
name: Motlabur Rahman, MBBS, FCPS,FACP
role: PRINCIPAL_INVESTIGATOR
References:
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.