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Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection

Primary Purpose

COVID-19 Pandemic

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Colchicine 0.5 MG
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pandemic

Eligibility Criteria

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

Inclusion Criteria:

  • 1. Patients with age above 18 years and of any gender 2. Definite diagnosis of COVID-19 according to the WHO classification criteria 3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases 4. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

  1. Patients refuse to enrol in the study
  2. Patients with hypersensitivity to colchicine
  3. Patients with chronic diseases: Renal failure with eGFR<30 ml/min; chronic liver disease with hepatic failure (AST/ALT > 3x normal).; decompensated heart failure, long QT syndrome (QTc >450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and Metastatic cancer
  4. Pregnancy and breast feeding
  5. Medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.

Sites / Locations

  • University of Baghdad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Colchicine group

Control group

Arm Description

Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy

The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient: Acetaminophen 500mg on need Vitamin C 1000mg twice/ day Zinc 75-125 mg/day Vitamin D3 5000IU/day Azithromycin 250mg/day for 5 days Oxygen therapy/ C-Pap if needed Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed Mechanical ventilation, if needed

Outcomes

Primary Outcome Measures

- To assess the percentage of cure of the patients
evauated by normalization of clinical evaluation, laboratory investigations, and imaging
- Study the time to recovery
Evaluated by stay days in hospital

Secondary Outcome Measures

- to assess side effects seen during the trial
assessed according clinical evaluation and the appropriate laboratory investigation

Full Information

First Posted
November 27, 2021
Last Updated
November 27, 2021
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05151614
Brief Title
Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection
Official Title
Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

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

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
The study included 2 arms Colchicine group: Colchicine + standard therapy of COVID-19 Control group: Standard therapy of COVID-19
Detailed Description
This study will be a randomized controlled trial with 2 arms study trial 1:1 allocation. The sample size was calculated and we need a total of 160 patients (80 Colchicine add on group and 80 controls)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine group
Arm Type
Experimental
Arm Description
Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient: Acetaminophen 500mg on need Vitamin C 1000mg twice/ day Zinc 75-125 mg/day Vitamin D3 5000IU/day Azithromycin 250mg/day for 5 days Oxygen therapy/ C-Pap if needed Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed Mechanical ventilation, if needed
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 MG
Other Intervention Name(s)
Colchicine
Intervention Description
Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy ( total duration of colchicine 14 days).
Primary Outcome Measure Information:
Title
- To assess the percentage of cure of the patients
Description
evauated by normalization of clinical evaluation, laboratory investigations, and imaging
Time Frame
up to 14 days
Title
- Study the time to recovery
Description
Evaluated by stay days in hospital
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
- to assess side effects seen during the trial
Description
assessed according clinical evaluation and the appropriate laboratory investigation
Time Frame
up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients with age above 18 years and of any gender 2. Definite diagnosis of COVID-19 according to the WHO classification criteria 3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases 4. Understands and agrees to comply with planned study procedures. Exclusion Criteria: Patients refuse to enrol in the study Patients with hypersensitivity to colchicine Patients with chronic diseases: Renal failure with eGFR<30 ml/min; chronic liver disease with hepatic failure (AST/ALT > 3x normal).; decompensated heart failure, long QT syndrome (QTc >450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and Metastatic cancer Pregnancy and breast feeding Medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Abdulamir, MD
Organizational Affiliation
Alnahrin University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Baghdad
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection

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