Colchicine in Moderate Symptomatic COVID-19 Patients

NCT04527562 | Completed

• 1 other identifier: U1111-1255-3541
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid 19; Colchicine

Outcome Measures

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.

  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 Outcomes (4)

• Length of hospital stay

  14 days following randomization

• Number of participant requiring increased amount of supplemental oxygen

  14 days following randomization

• Number of participants requiring mechanical ventilation

  14 days following randomization

• Number of participants who die

  14 days following randomization

Study Arms (2)

TRAETMENT GROUP

ACTIVE COMPARATOR

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

CONTROL /PLACEBO GROUP

PLACEBO COMPARATOR

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: 1. Isolation facility 2. Symptomatic treatment with Paracetamol, Fexofenadine 3. Steam inhalation/Gurgle of Lukewarm water. 4. Ensuring of hand wash (20 seconds each time) and ideally wearing mask. 5. Monitoring by the attending nurses.

Drug: Placebo

Interventions

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.

TRAETMENT GROUP

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.

CONTROL /PLACEBO GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dhaka Medical College: lead

Study Sites (1)

Dhaka Medical College Hospital

Dhaka-1000, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 36383611 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Mujibur Rahman, MBBS,MD,FCPS

  Professor and Head, Department of Medicine

  STUDY CHAIR

• Motlabur Rahman, MBBS, FCPS,FACP

  Associate Professor, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 26, 2020
• Study Start: July 14, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 10, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)