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Colchicine and Post-COVID-19 Pulmonary Fibrosis

Primary Purpose

Covid19, Pulmonary Fibrosis Interstitial

Status

Active

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Colchicine 0.5 MG

the standard protocol only

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, Pulmonary Fibrosis, Colchicine, Clinical outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

El-Demerdash Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine group

Control group

Arm Description

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

the local standard protocol of COVID19 management

Outcomes

Primary Outcome Measures

Clinical status

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

Pulmonary fibrosis at week 2

Percent of Participants with pulmonary fibrosis

Pulmonary fibrosis at 45 days

Percent of Participants with pulmonary fibrosis

Secondary Outcome Measures

C-reactive protein

Change in the levels of C-reactive protein

Ferritin

Change in the levels of Ferritin

Erythrocyte sedimentation rate

Change in the levels of Erythrocyte sedimentation rate

Lactate dehydrogenase

Change in the levels of Lactate dehydrogenase

Adverse events

Adverse events related to the study medication

Pulmonary function test: FVC

Pulmonary function test: FEV1

Full Information

NCT ID

NCT04818489

First Posted

February 13, 2021

Last Updated

September 4, 2023

Sponsor

ClinAmygate

1. Study Identification

Unique Protocol Identification Number

NCT04818489

Brief Title

Colchicine and Post-COVID-19 Pulmonary Fibrosis

Official Title

Impact of Colchicine on the Clinical Outcome of COVID-19 and the Development of Post-COVID-19 Pulmonary Fibrosis: Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 25, 2021 (Actual)

Primary Completion Date

August 25, 2021 (Actual)

Study Completion Date

October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

ClinAmygate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Approximately 96 million people have been diagnosed with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and around two million people have died from this deadly disease worldwide. The pulmonary symptoms associated with SARS-CoV-2 vary from mild respiratory symptoms to severe respiratory failure. Of those infected with SARS-CoV-2, 40% will progress to ARDS. Radiologically, most of those infected by SARS COV 2 have bilateral lower lobes ground-glass opacities with or without consolidation. However, long term lung impairment may develop particularly interstitial lung disease (ILD), the fibrotic type. Besides, pulmonary fibrosis (PF) is recognized sequelae of ARDS, and several studies have shown that protective lung ventilation tends to diminish the radiographic abnormalities following ARDS. Colchicine has anti-fibrotic effects as a microtubule-destabilizing agent. In an in vitro study using human lung fibroblasts, colchicine inhibited myofibroblast differentiation via Rho/serum response factor (SRF) dependent. In COVID19 cases, colchicine was used by where they assessed its impact on the inflammatory biomarkers and clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Pulmonary Fibrosis Interstitial

Keywords

COVID19, Pulmonary Fibrosis, Colchicine, Clinical outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The radiologist who will assess the CT scans will be blinded

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colchicine group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

the local standard protocol of COVID19 management

Intervention Type

Drug

Intervention Name(s)

Colchicine 0.5 MG

Other Intervention Name(s)

Colchicine

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

the standard protocol only

Other Intervention Name(s)

the local standard protocol for COVID19

Intervention Description

the local standard protocol for COVID19

Primary Outcome Measure Information:

Title

Clinical status

Description

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

Time Frame

Two weeks

Title

Pulmonary fibrosis at week 2

Description

Percent of Participants with pulmonary fibrosis

Time Frame

Two weeks

Title

Pulmonary fibrosis at 45 days

Description

Percent of Participants with pulmonary fibrosis

Time Frame

45 days

Secondary Outcome Measure Information:

Title

C-reactive protein

Description

Change in the levels of C-reactive protein

Time Frame

Two weeks

Title

Ferritin

Description

Change in the levels of Ferritin

Time Frame

Two weeks

Title

Erythrocyte sedimentation rate

Description

Change in the levels of Erythrocyte sedimentation rate

Time Frame

Two weeks

Title

Lactate dehydrogenase

Description

Change in the levels of Lactate dehydrogenase

Time Frame

Two weeks

Title

Adverse events

Description

Adverse events related to the study medication

Time Frame

45 days

Title

Pulmonary function test: FVC

Description

Pulmonary function test: FVC

Time Frame

45 days

Title

Pulmonary function test: FEV1

Description

Pulmonary function test: FEV1

Time Frame

45 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emad Issak

Organizational Affiliation

Ain Shams Univeristy

Official's Role

Principal Investigator

Facility Information:

Facility Name

El-Demerdash Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32579195

Citation

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.

Results Reference

background

PubMed Identifier

34658014

Citation

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.

Results Reference

derived

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Colchicine and Post-COVID-19 Pulmonary Fibrosis

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