Effectiveness of Colchicine Among Patients With COVID-19 Infection

June 19, 2021 updated by: Aryan Mohamadfatih Jalal, Hawler Medical University
In November 2019, there were a lot of cases of an acute respiratory illness (then named at February 11th as COVID_19) which first case was reported in Wuhan, China,The SARS COV-2 had been spread in a fast way to involve whole world, As it's obvious that Colchicine is a drug that is most commonly and widely used to treat and prevent acute attacks of Gout, other crystal induced arthropathy,colchicine has important role in inhibiting activation of NLRP3 inflammasome these lead to decrease cytokine production , aim of study To evaluate whether colchicine is effective in the treatment of COVID-19 cases. And to measure the effectiveness of colchicine in alleviating and controlling pulmonary and extra pulmonary complications of COVID-19

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this is an open label, randomize control clinical trial ,the participant will be randomly assign in to two groups ( Group A and Group B), colchicine (group A) will treat with colchicine tablet alone or add to their Current treatment,Colchicine 0.5 mg twice daily (reduce to 0.5 mg/day, in patients with low body weight or develop side effects like gastrointestinal symptoms ),For 14 days or until symptoms subsides, while the control group will treat according to usual treatment guideline in COVID-19.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Erbil, Iraq, 44001
        • Hawler medical university ,Rozhawa emergency hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.patients diagnosed clinically or by RT-PCR in nasopharyngeal swab specimens and/ or lung involvement confirm by computed tomography scan compatible with COVID-19patients 2.Age between 18 year and 70 years, 3.body weight > 50 kg, 4.with written informed consent from patients or relatives.

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Exclusion Criteria 1 sensitivity to any medications of regimens, 2.e GFR less than 30. 3.pregnancy. 4.malignancy . 5.Participating in another clinical study and refusing to participate in the study at a later date or later, and they are already taking colchicine for other diseases .

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: colchicine drug
participant in this group will be given a colchicine tablet alone or add to their Current treatment, Colchicine 0.5 mg twice daily (reduced to 0.5 mg/day, in patients with low body weight or develop side effect like gastrointestinal symptoms ),For 14 days or until symptoms subsides.
Drug: Colchicine 0.5 MG
participant will be given a Colchicine regimen in a dose of 0.5mg twice daily for 14 days or until symptoms subsides,those with low body weight and develop side effect like diarrhea and vomiting dose will be reduced and supportive treatment will be given .
Other Names:
  • colcrys
  • colchicum
Active Comparator: usual care
control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
Drug: usual care treatment
control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
Other Names:
  • treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for supplemental oxygen
Time Frame: 14 days following randomization
number of patients need supplemental oxygen
14 days following randomization
length of hospital stay
Time Frame: 14 days following randomization
number of patients who admit to hospital and duration of stay
14 days following randomization
need for invasive mechanical ventilation
Time Frame: 14 days following randomization
number of patients need invasive mechanical ventilation
14 days following randomization
death rate
Time Frame: 14 days following randomization
number of patients who die during randomization
14 days following randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygen saturation measurement
Time Frame: 14 days following randomization
Sp02 measurement by pulse oximetry
14 days following randomization
musculoskeletal symptoms
Time Frame: 14 days following randomization
participants who have back pain and myalgia measure by patient analogue scale of pain
14 days following randomization
change in severity marker
Time Frame: 14 days following randomization
CRP measurement
14 days following randomization
change in inflammatory marker
Time Frame: 14 days following randomization
ferritin
14 days following randomization
change in severity marker
Time Frame: 14 days following randomization
D.Dimer
14 days following randomization
change in marker
Time Frame: 14 days following randomization
leukocyte
14 days following randomization
adverse effect
Time Frame: 14 days following randomization
number of participants who develop adverse effect with treatment
14 days following randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Investigators

  • Study Director: Dashty Albustany, MBChB.FRCP, assistant professor in medicine,consultant Rheumatologist
  • Principal Investigator: Aryan MF Jalal, M.B.CH.B, doctor Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2021

Primary Completion (Actual)

June 18, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 19, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effectiveness of colchicine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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