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

NCT05151614 | Completed Phase 1

• 1 other identifier: PRO21230003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (2)

• - To assess the percentage of cure of the patients

  evauated by normalization of clinical evaluation, laboratory investigations, and imaging

  up to 14 days

• - Study the time to recovery

  Evaluated by stay days in hospital

  up to 14 days

Secondary Outcomes (1)

• - to assess side effects seen during the trial

  up to 14 days

Study Arms (2)

Colchicine group

EXPERIMENTAL

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

Drug: Colchicine 0.5 MG

Control group

NO INTERVENTION

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

Interventions

Colchicine 0.5 MG 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).

Also known as: Colchicine

Colchicine group

Eligibility Criteria

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

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Ahmed S Abdulamir, MD

  Alnahrin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 9, 2021
• Study Start: April 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)