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NCT05118737

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

Status unknown EARLY_PHASE1 Last updated 3 December 2021
What this trial tests

EARLY_PHASE1 trial testing Colchicine in COVID-19 Pneumonia in 230 participants. Status unknown.

Timeline
1 October 2021
Primary endpoint
30 April 2022
30 August 2022

Quick facts

Lead sponsorHamad Medical Corporation
PhaseEARLY_PHASE1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment230
Start date1 October 2021
Primary completion30 April 2022
Estimated completion30 August 2022
Sites1 location across Qatar

Drugs / interventions tested

Conditions studied

Sponsor

Hamad Medical Corporation — full company profile →

Who can join

Adults 18 to 90, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The role of inflammasomes in human diseases and their potential as therapeutic targets.
    Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
  2. Immunotherapy of COVID-19: Inside and Beyond IL-6 Signalling.
    Zizzo G, Tamburello A, Castelnovo L, Laria A, et al · · 2022 · cited 55× · PMID 35340805 · DOI 10.3389/fimmu.2022.795315
  3. Repurposing of drugs targeting the cytokine storm induced by SARS-CoV-2.
    Ng WH, Tang PCH, Mahalingam S, Liu X. · · 2023 · cited 7× · PMID 36394425 · DOI 10.1111/bph.15987
  4. Therapeutic Targeting of Innate Immune Receptors Against SARS-CoV-2 Infection.
    Farooq M, Khan AW, Ahmad B, Kim MS, et al · · 2022 · cited 5× · PMID 35847031 · DOI 10.3389/fphar.2022.915565
  5. Adding colchicine to tocilizumab in hospitalized patients with severe COVID-19 pneumonia: An open-label randomized controlled trial.
    Rahhal A, Najim M, Aljundi AH, Mahfouz A, et al · · 2022 · cited 3× · PMID 36181009 · DOI 10.1097/md.0000000000030843

Verify or expand the search:

Other trials of Colchicine

Trials testing the same drug.

Other recruiting trials for COVID-19 Pneumonia

Currently open trials in the same condition.

Other Hamad Medical Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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