NCT04667780

Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19

Completed Phase 3 Last updated 5 January 2023

What this trial tests

Phase 3 trial testing Colchicine in COVID-19 in 102 participants. Completed in 9 July 2021.

Timeline

1 December 2020

Primary endpoint
9 July 2021

9 July 2021

Quick facts

Lead sponsor	Ayub Teaching Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	1 December 2020
Primary completion	9 July 2021
Estimated completion	9 July 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• Colchicine (COLCHICINE) — full drug profile →
• Standard COVID-19 care — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Ayub Teaching Hospital

Who can join

Adults 18 to 65, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. The investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but no intensive care yet. Colchicine will be started within the first 48 hours and continue for 14 days using a descending dose. The benefits will be studied in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is affordable and widely accessible which would help to prevent the inflammatory complications associated with COVID-19.

Publications & conference data

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

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Cardiac involvement in the long-term implications of COVID-19.
   Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
3. Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
   Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
4. Colchicine for the treatment of COVID-19.
   Mikolajewska A, Fischer AL, Piechotta V, Mueller A, et al · · 2021 · cited 40× · PMID 34658014 · DOI 10.1002/14651858.cd015045
5. NETosis and the Immune System in COVID-19: Mechanisms and Potential Treatments.
   Gillot C, Favresse J, Mullier F, Lecompte T, et al · · 2021 · cited 39× · PMID 34421600 · DOI 10.3389/fphar.2021.708302
6. Colchicine for the treatment of COVID-19 patients: efficacy, safety, and model informed dosage regimens.
   Karatza E, Ismailos G, Karalis V. · · 2021 · cited 26× · PMID 33845715 · DOI 10.1080/00498254.2021.1909782
7. Meta-analysis of the Effect of Colchicine on Mortality and Mechanical Ventilation in COVID-19.
   Salah HM, Mehta JL. · · 2021 · cited 23× · PMID 33617817 · DOI 10.1016/j.amjcard.2021.02.005
8. <i>In silico</i> investigation and potential therapeutic approaches of natural products for COVID-19: Computer-aided drug design perspective.
   Rahman MM, Islam MR, Akash S, Mim SA, et al · · 2022 · cited 18× · PMID 36072227 · DOI 10.3389/fcimb.2022.929430