Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia.

NCT05118737 | Unknown Early Phase 1 DMC

• 1 other identifier: MRC-01-21-299
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Colchicine acts upstream in the cytokines cascade by inhibiting the NLRP3 inflammasome while IL-6 receptor antagonists (tocilizumab) block the end result of the cytokines cascade. Hence, adding colchicine to tocilizumab with the aim of blocking the early and end products of the cytokines cascade, might reduce the risk of developing cytokine storm and hence the need for invasive mechanical ventilation and eventually death. Therefore, investigators aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia in an attempt to reduce the rate of invasive mechanical ventilation and mortality. Investigators will include patients with severe COVID-19 pneumonia and already received tocilizumab according to local protocol. Enrolled patient will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up until discharge or for 30 days, whichever comes first. Data will be collected from electronic medical profiles. The primary efficacy outcome will be rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model.

Conditions

COVID-19 Pneumonia

Keywords

COVID-19 Pneumonia; Cholchicin

Outcome Measures

Primary Outcomes (1)

• Rate of invasive mechanical ventilation

  Rate of invasive mechanical ventilation among patients who received colchicine versus those who did not receive colchicine

  6 months

Secondary Outcomes (8)

• Time to invasive mechanical ventilation

  6 months

• Duration of invasive mechanical ventilation

  6 months

• Mortality

  6 months

• ICU length of stay

  6 months

• Hospital length of stay

  6 months

Study Arms (2)

colchicine

ACTIVE COMPARATOR

Intervention arm: colchicine to be used among COVID-19 patients admitted to HMGH, CH, and CDC and already received tocilizumab

Drug: Colchicine

Control

PLACEBO COMPARATOR

COVID-19 patients admitted to HMGH, CH, and CDC and already received tocilizumab according to local protocol

Drug: Colchicine

Interventions

Colchicine DRUG

colchicine to be used among COVID-19 patients admitted to HMGH, CH, and CDC and already received tocilizumab

Also known as: Colcrys

Control; colchicine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Alert and conscious adults with the age of \> 18 years old Severe COVID-19 pneumonia
• o SpO2 \<94% on room air at sea level, respiratory frequency \>30 breaths/min, or lung infiltrates \>50%
• Received tocilizumab within 10 days prior to enrollment
• Tocilizumab is co-admisnitered with a systemic corticosteroid
• Agree to sign conflict of interest

You may not qualify if:

• \- Severe COVID-19 pneumonia requiring invasive mechanical ventilation
• Creatinine clearance \< 30 mL/min
• End stage renal disease on hemodialysis
• ALT and/or AST \> 5 upper limit of normal
• Pregnancy
• Lactation
• To prevent colchicine toxicity, patients receiving a strong CYP3A4 inhibitor (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (eg diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a P-gp Inhibitor (eg cyclosporine, ranolazine), will be excluded

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Alaa Rahal

Doha, DA, 3050, Qatar

RECRUITING

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Alaa Rahhal, Msc

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Rahhal, Msc

CONTACT

+97455712353; arahhal1@hamad.qa

Amr Omar, MD, PhD

CONTACT

+97466480831; aelsid@hamad.qa

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: \- To evaluate the efficacy of colchicine versus no colchicine in terms of the need of invasive mechanical ventilation among patients with severe COVID-19 pneumonia who received tocilizumab

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 12, 2021
• Study Start: October 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: August 30, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)