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Effectiveness of Colchicine Among Patients With COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04867226
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Aryan Mohamadfatih Jalal, Hawler Medical University

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

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Colchicine 0.5 MG Drug: usual care treatment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 100 Patients will participate for eligibility and enroll in the study, an open labell randomize control clinical trial will held among patients who will infect with COVID-19 in whom they met the inclusion criteria, either treat at home with healthcare advises and follow up or at centres of COVID-19 in ERBIL city ( Rozhawa emergency hospital, Erbil international private hospital) .
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Colchicine Among Patients With COVID-19 Infection
Actual Study Start Date : May 8, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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 Name: treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867226


Contacts
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Contact: Aryan MF Jalal, M.B.ch.B 009647504880817 aryan.jalal87@yahoo.com
Contact: Sheelan F Aref, M.b.Ch.B 009647501163636 Shelan_aref@hotmail.com

Locations
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Iraq
Hawler medical university ,Rozhawa emergency hospital Recruiting
Erbil, Iraq, 44001
Sponsors and Collaborators
Hawler Medical University
Investigators
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Study Director: Dashty Albustany, MBChB.FRCP assistant professor in medicine,consultant Rheumatologist
Principal Investigator: Aryan MF Jalal M.B.CH.B, doctor Rheumatology
Publications:

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Responsible Party: Aryan Mohamadfatih Jalal, Doctor Rheumatollogy, Hawler Medical University
ClinicalTrials.gov Identifier: NCT04867226    
Other Study ID Numbers: Effectiveness of colchicine
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aryan Mohamadfatih Jalal, Hawler Medical University:
covid-19, colchicine
Erbil,Iraq
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents