Effectiveness of Colchicine Among Patients With COVID-19 Infection

NCT ID: NCT04867226

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-08
• Study Completion Date: 2021-06-18

Brief Summary

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

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.

Conditions

Coronavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Colchicine 0.5 MG

Intervention Type: DRUG

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 .

usual care

control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.

Group Type: ACTIVE_COMPARATOR

usual care treatment

Intervention Type: DRUG

control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.

Interventions

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 .

Intervention Type: DRUG

usual care treatment

control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.

Intervention Type: DRUG

Other Intervention Names

colcrys; colchicum; treatment

Eligibility Criteria

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.

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Aryan Mohamadfatih Jalal

Doctor Rheumatollogy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dashty Albustany, MBChB.FRCP

Role: STUDY_DIRECTOR

assistant professor in medicine,consultant Rheumatologist

Aryan MF Jalal

Role: PRINCIPAL_INVESTIGATOR

M.B.CH.B, doctor Rheumatology

Locations

Hawler medical university ,Rozhawa emergency hospital

Erbil, , Iraq

Countries

Iraq

References

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

Effectiveness of colchicine

Identifier Type: -

Identifier Source: org_study_id