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Effectiveness of Colchicine Among Patients With COVID-19 Infection

Primary Purpose

Coronavirus Infection

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Colchicine 0.5 MG
usual care treatment
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring covid-19, colchicine, Erbil,Iraq

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Hawler medical university ,Rozhawa emergency hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

colchicine drug

usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

need for supplemental oxygen
number of patients need supplemental oxygen
length of hospital stay
number of patients who admit to hospital and duration of stay
need for invasive mechanical ventilation
number of patients need invasive mechanical ventilation
death rate
number of patients who die during randomization

Secondary Outcome Measures

oxygen saturation measurement
Sp02 measurement by pulse oximetry
musculoskeletal symptoms
participants who have back pain and myalgia measure by patient analogue scale of pain
change in severity marker
CRP measurement
change in inflammatory marker
ferritin
change in severity marker
D.Dimer
change in marker
leukocyte
adverse effect
number of participants who develop adverse effect with treatment

Full Information

First Posted
April 25, 2021
Last Updated
June 19, 2021
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04867226
Brief Title
Effectiveness of Colchicine Among Patients With COVID-19 Infection
Official Title
Effectiveness of Colchicine Among Patients With COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2021 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
Keywords
covid-19, colchicine, Erbil,Iraq

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
colchicine drug
Arm Type
Active Comparator
Arm Description
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.
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 MG
Other Intervention Name(s)
colcrys, colchicum
Intervention Description
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
Intervention Name(s)
usual care treatment
Other Intervention Name(s)
treatment
Intervention Description
control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
Primary Outcome Measure Information:
Title
need for supplemental oxygen
Description
number of patients need supplemental oxygen
Time Frame
14 days following randomization
Title
length of hospital stay
Description
number of patients who admit to hospital and duration of stay
Time Frame
14 days following randomization
Title
need for invasive mechanical ventilation
Description
number of patients need invasive mechanical ventilation
Time Frame
14 days following randomization
Title
death rate
Description
number of patients who die during randomization
Time Frame
14 days following randomization
Secondary Outcome Measure Information:
Title
oxygen saturation measurement
Description
Sp02 measurement by pulse oximetry
Time Frame
14 days following randomization
Title
musculoskeletal symptoms
Description
participants who have back pain and myalgia measure by patient analogue scale of pain
Time Frame
14 days following randomization
Title
change in severity marker
Description
CRP measurement
Time Frame
14 days following randomization
Title
change in inflammatory marker
Description
ferritin
Time Frame
14 days following randomization
Title
change in severity marker
Description
D.Dimer
Time Frame
14 days following randomization
Title
change in marker
Description
leukocyte
Time Frame
14 days following randomization
Title
adverse effect
Description
number of participants who develop adverse effect with treatment
Time Frame
14 days following randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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 . -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dashty Albustany, MBChB.FRCP
Organizational Affiliation
assistant professor in medicine,consultant Rheumatologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aryan MF Jalal
Organizational Affiliation
M.B.CH.B, doctor Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawler medical university ,Rozhawa emergency hospital
City
Erbil
ZIP/Postal Code
44001
Country
Iraq

12. IPD Sharing Statement

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Effectiveness of Colchicine Among Patients With COVID-19 Infection

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