NCT04416334: COLCHI-COVID

PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

Completed Phase 3 Last updated 8 November 2023

What this trial tests

Phase 3 trial testing Colchicine plus symptomatic treatment (paracetamol) in SARS-CoV-2 Infection (COVID-19) in 70 participants. Completed in 11 October 2022.

Timeline

19 August 2020

Primary endpoint
1 June 2022

11 October 2022

Quick facts

Lead sponsor	Instituto de Investigación Marqués de Valdecilla
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	70
Start date	19 August 2020
Primary completion	1 June 2022
Estimated completion	11 October 2022
Sites	4 locations across Spain

Drugs / interventions tested

• Colchicine plus symptomatic treatment (paracetamol) — full drug profile →
• Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) — full drug profile →

Conditions studied

• SARS-CoV-2 Infection (COVID-19) — all drugs for SARS-CoV-2 Infection (COVID-19) →

Sponsor

Instituto de Investigación Marqués de Valdecilla — full company profile →

Who can join

60 and older, any sex, with SARS-CoV-2 Infection (COVID-19). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

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. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
4. Metabolic alterations upon SARS-CoV-2 infection and potential therapeutic targets against coronavirus infection.
   Chen P, Wu M, He Y, Jiang B, et al · · 2023 · cited 50× · PMID 37286535 · DOI 10.1038/s41392-023-01510-8
5. 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
6. The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.
   Pillaiyar T, Wendt LL, Manickam M, Easwaran M. · · 2021 · cited 32× · PMID 32852058 · DOI 10.1002/med.21724
7. 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
8. Therapeutic Options for COVID-19: A Review.
   Pujari R, Thommana MV, Ruiz Mercedes B, Serwat A. · · 2020 · cited 19× · PMID 32953365 · DOI 10.7759/cureus.10480