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

NCT ID: NCT05151614

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-10-30

Brief Summary

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The study included 2 arms Colchicine group: Colchicine + standard therapy of COVID-19 Control group: Standard therapy of COVID-19

Detailed Description

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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)

Conditions

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COVID-19 Pandemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colchicine group

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

Group Type EXPERIMENTAL

Colchicine 0.5 MG

Intervention Type DRUG

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).

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colchicine 0.5 MG

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).

Intervention Type DRUG

Other Intervention Names

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Colchicine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Faiq Gorial

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed S Abdulamir, MD

Role: STUDY_CHAIR

Alnahrin University

Locations

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University of Baghdad

Baghdad, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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PRO21230003

Identifier Type: -

Identifier Source: org_study_id