NCT04328480

Brief Summary

The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality and/or new requirement for mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,279

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Apr 2020

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

April 17, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

March 30, 2020

Last Update Submit

April 26, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • Composite outcome: New requirement for mechanical ventilation or death

    Number of participants who require new intubation for mechanical ventilation or die

    28 days post randomization

  • Mortality

    Number of participants who die

    28 days post randomization

Secondary Outcomes (10)

  • New requirement for mechanical ventilation or death from respiratory failure

    28 days post randomization

  • New requirement for mechanical ventilation or death from non-respiratory failure

    28 days post randomization

  • Mortality due to respiratory failure

    28 days post randomization

  • Mortality due to non-respiratory failure

    28 days post randomization

  • In hospital - Composite outcome

    During hospitalization or until death, whichever comes first, assessed up to 28 days

  • +5 more secondary outcomes

Study Arms (2)

Local standard of care plus colchicine

ACTIVE COMPARATOR

Local standard of care plus colchicine (specific dosage schedule)

Drug: ColchicineOther: Local standard of care

Local standard of care

OTHER

Local standard of care for COVID-19 SARS moderate / high-risk patients

Other: Local standard of care

Interventions

ColchicineDRUG

The colchicine dosage schedule will vary according to the following scenarios: 1. In patients not receiving Lopinavir/Ritonavir * Loading dose of 1.5 mg followed by 0.5 mg after two hours (day 1) * The next day 0.5 mg bid for 14 days or until discharge. 2. In patients receiving Lopinavir/Ritonavir * Loading dose of 0.5 mg (day 1) * After 72 hours from the loading dose, 0.5 mg every 72 hours for 14 days or until discharge. 3. Patients under treatment with Colchicine that are starting with Lopinavir/Ritonavir * Dose of 0.5 mg 72 hours after starting Lopinavir/Ritonavir. * Continue with 0.5 mg every 72 hours for 14 days or until discharge. Only the oral route will be used except in the case of patients associated with mechanical ventilation or with contraindications to the oral route, in whom it will be administered by nasogastric tube.

Also known as: Colchicina
Local standard of care plus colchicine
Local standard of careOTHER

Local standard of care for COVID-19 SARS moderate /high-risk patients

Local standard of careLocal standard of care plus colchicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consented adults (age ≥18 years) and
  • COVID-19 suspicious and
  • Admitted to hospital or already in hospital and
  • COVID-19 suggestive symptoms (fever or febrile equivalent, loss of smell and taste, fatigue, etc.) that may be present or absent at randomization time and
  • SARS (severe acute respiratory syndrome)
  • shortness of breath (dyspnea) or
  • image of typical or atypical pneumonia or
  • oxygen desaturation (SpO2 ≤ 93)

You may not qualify if:

  • Clear indication or contraindication for the use of colchicine
  • Pregnant or breastfeeding female.
  • Chronic renal disease with creatinine clearance \<15 ml/min/m2
  • Negative PCR test for SARS-COV2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio Parque

Rosario, Santa Fe Province, 2000, Argentina

Location

Related Publications (6)

  • Slobodnick A, Shah B, Krasnokutsky S, Pillinger MH. Update on colchicine, 2017. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i4-i11. doi: 10.1093/rheumatology/kex453.

    PMID: 29272515BACKGROUND

  • Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.

    PMID: 31733140BACKGROUND

  • Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409-22. doi: 10.1002/sim.4780030421. No abstract available.

    PMID: 6528136BACKGROUND

  • McDermott MM, Newman AB. Preserving Clinical Trial Integrity During the Coronavirus Pandemic. JAMA. 2020 Jun 2;323(21):2135-2136. doi: 10.1001/jama.2020.4689. No abstract available.

    PMID: 32211830BACKGROUND

  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PMID: 32192578RESULT

  • Diaz R, Orlandini A, Castellana N, Caccavo A, Corral P, Corral G, Chacon C, Lamelas P, Botto F, Diaz ML, Dominguez JM, Pascual A, Rovito C, Galatte A, Scarafia F, Sued O, Gutierrez O, Jolly SS, Miro JM, Eikelboom J, Loeb M, Maggioni AP, Bhatt DL, Yusuf S; ECLA PHRI COLCOVID Trial Investigators. Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2141328. doi: 10.1001/jamanetworkopen.2021.41328.

    PMID: 34964849DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Rafael Diaz, MD

    ECLA- ICR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Simple pragmatic randomized open controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

March 31, 2020

Study Start

April 17, 2020

Primary Completion

April 25, 2021

Study Completion

April 26, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)