NCT04818489

Brief Summary

Pulmonary fibrosis is a sequela to adult respiratory distress syndrome (ARDS). 40% of patients with corona virus disease 2019 (COVID-19) develop ARDS, and 20% of them are severe. Clinical, radiographic, and autopsy reports of pulmonary fibrosis were commonplace following SARS and MERS, and current evidence suggests pulmonary fibrosis could complicate infection by SARS-CoV-2 too. Colchicine has a direct anti-inflammatory effect by inhibiting the synthesis of tumor necrosis factor alpha and IL-6, monocyte migration, and the secretion of matrix metalloproteinase-9. It suppress secretion of cytokines and chemokines as well as in vitro platelet aggregation. All these are potentially beneficial effects that might diminish the COVID-19 inflammatory storm associated with severe cases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P50-P75 for phase_4 covid19

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
unknown

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

February 13, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

February 13, 2021

Last Update Submit

September 4, 2023

Conditions

Covid19Pulmonary Fibrosis Interstitial

Keywords

COVID19Pulmonary FibrosisColchicineClinical outcomes

Outcome Measures

Primary Outcomes (3)

  • Clinical status

    Seven-category ordinal scale: minimum 1 is the best and a maximum is 6

    Two weeks

  • Pulmonary fibrosis at week 2

    Percent of Participants with pulmonary fibrosis

    Two weeks

  • Pulmonary fibrosis at 45 days

    Percent of Participants with pulmonary fibrosis

    45 days

Secondary Outcomes (7)

  • C-reactive protein

    Two weeks

  • Ferritin

    Two weeks

  • Erythrocyte sedimentation rate

    Two weeks

  • Lactate dehydrogenase

    Two weeks

  • Adverse events

    45 days

  • +2 more secondary outcomes

Study Arms (2)

Colchicine group

EXPERIMENTAL

Colchicine 0.5 mg (2 tablets: 1 mg) twice per day as a loading dose, followed by one tablet 0.5 twice per day for three weeks in addition to the local standard protocol of COVID19 management

Drug: Colchicine 0.5 MGOther: the standard protocol only

Control group

PLACEBO COMPARATOR

the local standard protocol of COVID19 management

Other: the standard protocol only

Interventions

Colchicine 0.5 MGDRUG

colchicine 0.5 mg (2 tablets: 1 mg) twice per day as a loading dose, followed by one tablet 0.5 twice per day for three weeks in addition to the standard protocol

Also known as: Colchicine
Colchicine group
the standard protocol onlyOTHER

the local standard protocol for COVID19

Also known as: the local standard protocol for COVID19
Colchicine groupControl group

Eligibility Criteria

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

You may qualify if:

  • Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
  • Age above 18 years old
  • Informed written consent

You may not qualify if:

  • History of hypersensitivity to colchicine
  • Pregnancy or breastfeeding women.
  • Patients with severe renal impairment (creatinine clearance (CCL) \<30 mL / min)
  • Patients with severe hepatic impairment (AST or ALT\> 5 times the normal limits in International Units (ULN)
  • Patients with blood dyscrasias, neutrophils \<1.000 / mmc or platelets \<50.000 / mmc
  • Patients with history of severe cardiac insufficiency
  • Patients with history of pulmonary fibrosis
  • Severe diarrhoea or bowel diverticulitis, or perforation
  • Patients who cannot take oral therapy
  • Patients already in ICU or requiring mechanical ventilation
  • Patients already enrolled in other clinical trials
  • Patients with taking P-glycoprotein inhibitor (e.g. ciclosporin, verapamil or quinidine) or a CYP3A4 inhibitor (e.g. ritonavir, remdesivir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole) or Tocilizumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Demerdash Hospital

Cairo, Egypt

Location

Related Publications (2)

  • Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P, Metallidis S, Sianos G, Baltagiannis S, Panagopoulos P, Dolianitis K, Randou E, Syrigos K, Kotanidou A, Koulouris NG, Milionis H, Sipsas N, Gogos C, Tsoukalas G, Olympios CD, Tsagalou E, Migdalis I, Gerakari S, Angelidis C, Alexopoulos D, Davlouros P, Hahalis G, Kanonidis I, Katritsis D, Kolettis T, Manolis AS, Michalis L, Naka KK, Pyrgakis VN, Toutouzas KP, Triposkiadis F, Tsioufis K, Vavouranakis E, Martinez-Dolz L, Reimers B, Stefanini GG, Cleman M, Goudevenos J, Tsiodras S, Tousoulis D, Iliodromitis E, Mehran R, Dangas G, Stefanadis C; GRECCO-19 investigators. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. doi: 10.1001/jamanetworkopen.2020.13136.

    PMID: 32579195BACKGROUND

  • Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

    PMID: 34658014DERIVED

MeSH Terms

Conditions

COVID-19Pulmonary Fibrosis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Emad Issak

    Ain Shams Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The radiologist who will assess the CT scans will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 13, 2021

First Posted

March 26, 2021

Study Start

March 25, 2021

Primary Completion

August 25, 2021

Study Completion

October 20, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)