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OpenTrials
Completed

NCT Number: NCT04867226

Effectiveness of Colchicine Among Patients With COVID-19 Infection

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

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Key information

Conditions

Coronavirus Infection 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hawler medical university ,Rozhawa emergency hospital

Erbil, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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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Treatment and study plan

Colchicine 0.5 MG

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 .

Other names: colcrys, colchicum

usual care treatment

Drug

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

Other names: treatment

Primary outcomes

  1. need for supplemental oxygen

    Time frame: 14 days following randomization

    number of patients need supplemental oxygen

  2. length of hospital stay

    Time frame: 14 days following randomization

    number of patients who admit to hospital and duration of stay

  3. need for invasive mechanical ventilation

    Time frame: 14 days following randomization

    number of patients need invasive mechanical ventilation

  4. death rate

    Time frame: 14 days following randomization

    number of patients who die during randomization

Secondary outcomes

  1. oxygen saturation measurement

    Time frame: 14 days following randomization

    Sp02 measurement by pulse oximetry

  2. musculoskeletal symptoms

    Time frame: 14 days following randomization

    participants who have back pain and myalgia measure by patient analogue scale of pain

  3. change in severity marker

    Time frame: 14 days following randomization

    CRP measurement

  4. change in inflammatory marker

    Time frame: 14 days following randomization

    ferritin

  5. change in severity marker

    Time frame: 14 days following randomization

    D.Dimer

  6. change in marker

    Time frame: 14 days following randomization

    leukocyte

  7. adverse effect

    Time frame: 14 days following randomization

    number of participants who develop adverse effect with treatment

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Jun 22, 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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