Effectiveness of Colchicine Among Patients With COVID-19 Infection

NCT04867226 | Completed Phase 2

• 1 other identifier: Effectiveness of colchicine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Coronavirus Infection

Keywords

covid-19, colchicine; Erbil,Iraq

Outcome Measures

Primary Outcomes (4)

• need for supplemental oxygen

  number of patients need supplemental oxygen

  14 days following randomization

• length of hospital stay

  number of patients who admit to hospital and duration of stay

  14 days following randomization

• need for invasive mechanical ventilation

  number of patients need invasive mechanical ventilation

  14 days following randomization

• death rate

  number of patients who die during randomization

  14 days following randomization

Secondary Outcomes (7)

• oxygen saturation measurement

  14 days following randomization

• musculoskeletal symptoms

  14 days following randomization

• change in severity marker

  14 days following randomization

• change in inflammatory marker

  14 days following randomization

• change in severity marker

  14 days following randomization

Study Arms (2)

colchicine drug

ACTIVE COMPARATOR

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

usual care

ACTIVE COMPARATOR

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

Drug: usual care treatment

Interventions

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 .

Also known as: colcrys, colchicum

colchicine drug

usual care treatment DRUG

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

Also known as: treatment

usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler medical university ,Rozhawa emergency hospital

Erbil, 44001, Iraq

Location

Related Publications (11)

• 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. No abstract available.

  PMID: 31950516 BACKGROUND

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

  PMID: 32353870 BACKGROUND

• 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. No abstract available.

  PMID: 32192578 BACKGROUND

• 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.

  PMID: 32167524 BACKGROUND

• 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.

  PMID: 32504757 BACKGROUND

• 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.

  PMID: 26922692 BACKGROUND

• 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. No abstract available.

  PMID: 32302081 BACKGROUND

• 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.

  PMID: 32031570 BACKGROUND

• 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.

  PMID: 22660810 BACKGROUND

• 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.

  PMID: 29272515 BACKGROUND

• Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

  PMID: 34658014 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Colchicine; Therapeutics

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Dashty Albustany, MBChB.FRCP

  assistant professor in medicine,consultant Rheumatologist

  STUDY DIRECTOR

• Aryan MF Jalal

  M.B.CH.B, doctor Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Rheumatollogy

Model Details: 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) .

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 30, 2021
• Study Start: May 8, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

IR (1)