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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04867226
Other study ID # Effectiveness of colchicine
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 8, 2021
Est. completion date June 18, 2021

Study information

Verified date June 2021
Source Hawler Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 18, 2021
Est. primary completion date June 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 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 . -

Study Design


Intervention

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

Locations

Country Name City State
Iraq Hawler medical university ,Rozhawa emergency hospital Erbil

Sponsors (1)

Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

References & Publications (10)

Alhogbani T. Acute myocarditis associated with novel Middle east respiratory syndrome coronavirus. Ann Saudi Med. 2016 Jan-Feb;36(1):78-80. doi: 10.5144/0256-4947.2016.78. — View Citation

Bangalore S, Sharma A, Slotwiner A, Yatskar L, Harari R, Shah B, Ibrahim H, Friedman GH, Thompson C, Alviar CL, Chadow HL, Fishman GI, Reynolds HR, Keller N, Hochman JS. ST-Segment Elevation in Patients with Covid-19 - A Case Series. N Engl J Med. 2020 Jun 18;382(25):2478-2480. doi: 10.1056/NEJMc2009020. Epub 2020 Apr 17. — View Citation

Banu N, Panikar SS, Leal LR, Leal AR. Protective role of ACE2 and its downregulation in SARS-CoV-2 infection leading to Macrophage Activation Syndrome: Therapeutic implications. Life Sci. 2020 Sep 1;256:117905. doi: 10.1016/j.lfs.2020.117905. Epub 2020 Jun 3. Review. — View Citation

Crittenden DB, Lehmann RA, Schneck L, Keenan RT, Shah B, Greenberg JD, Cronstein BN, Sedlis SP, Pillinger MH. Colchicine use is associated with decreased prevalence of myocardial infarction in patients with gout. J Rheumatol. 2012 Jul;39(7):1458-64. doi: 10.3899/jrheum.111533. Epub 2012 Jun 1. — View Citation

Lu H, Stratton CW, Tang YW. Outbreak of pneumonia of unknown etiology in Wuhan, China: The mystery and the miracle. J Med Virol. 2020 Apr;92(4):401-402. doi: 10.1002/jmv.25678. Epub 2020 Feb 12. — View Citation

Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. — View Citation

Slobodnick A, Shah B, Krasnokutsky S, Pillinger MH. Update on colchicine, 2017. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i4-i11. doi: 10.1093/rheumatology/kex453. Review. — View Citation

Vardhana SA, Wolchok JD. The many faces of the anti-COVID immune response. J Exp Med. 2020 Jun 1;217(6). pii: e20200678. doi: 10.1084/jem.20200678. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113. — View Citation

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary need for supplemental oxygen number of patients need supplemental oxygen 14 days following randomization
Primary length of hospital stay number of patients who admit to hospital and duration of stay 14 days following randomization
Primary need for invasive mechanical ventilation number of patients need invasive mechanical ventilation 14 days following randomization
Primary death rate number of patients who die during randomization 14 days following randomization
Secondary oxygen saturation measurement Sp02 measurement by pulse oximetry 14 days following randomization
Secondary musculoskeletal symptoms participants who have back pain and myalgia measure by patient analogue scale of pain 14 days following randomization
Secondary change in severity marker CRP measurement 14 days following randomization
Secondary change in inflammatory marker ferritin 14 days following randomization
Secondary change in severity marker D.Dimer 14 days following randomization
Secondary change in marker leukocyte 14 days following randomization
Secondary adverse effect number of participants who develop adverse effect with treatment 14 days following randomization
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