Covid19Phase 4NCT04818489
Colchicine and Post-COVID-19 Pulmonary Fibrosis
A Phase 4 study testing Colchicine 0.5 MG and the standard protocol only in people with Covid19 and Pulmonary Fibrosis Interstitial, run by ClinAmygate at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Pulmonary Fibrosis Interstitial
- What is being tested?
- Colchicine 0.5 MG and the standard protocol only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2021to 20 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
- Age above 18 years old
- Informed written consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19, Pulmonary Fibrosis Interstitial
- Being tested
- Colchicine 0.5 MG, the standard protocol only
- Keywords
- COVID19, Pulmonary Fibrosis, Colchicine, Clinical outcomes
- Medical subject headings
- COVID-19, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Also called Colchicine
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
the standard protocol onlyOther
Also called the local standard protocol for COVID19
the local standard protocol for COVID19
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Colchicine 0.5 MG; Other: the standard protocol only |
| Control group | Placebo comparator | the local standard protocol of COVID19 management Receives: Other: the standard protocol only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status
Seven-category ordinal scale: minimum 1 is the best and a maximum is 6
Measured: Two weeks
Pulmonary fibrosis at week 2
Percent of Participants with pulmonary fibrosis
Measured: Two weeks
Pulmonary fibrosis at 45 days
Percent of Participants with pulmonary fibrosis
Measured: 45 days
Secondary outcomes (7)
C-reactive protein
Change in the levels of C-reactive protein
Measured: Two weeks
Ferritin
Change in the levels of Ferritin
Measured: Two weeks
Erythrocyte sedimentation rate
Change in the levels of Erythrocyte sedimentation rate
Measured: Two weeks
Lactate dehydrogenase
Change in the levels of Lactate dehydrogenase
Measured: Two weeks
Adverse events
Adverse events related to the study medication
Measured: 45 days
Pulmonary function test: FVC
Pulmonary function test: FVC
Measured: 45 days
Pulmonary function test: FEV1
Pulmonary function test: FEV1
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start25 Mar 2021
- Primary completion25 Aug 2021
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad R Issak, ClinAmygate
- Investigators
- Emad Issak, Principal investigator, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818489
- Sponsor's protocol ID
- PR00202
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32579195Mikolajewska 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.
PubMed 34658014
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04818489
- Acronym / sponsor ID
- PR00202
- Conditions
- Covid19, Pulmonary Fibrosis Interstitial
- Keywords
- COVID19, Pulmonary Fibrosis, Colchicine, Clinical outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine 0.5 MG, Other: the standard protocol onlyColchicine 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 |
| Control group | Placebo comparator | Other: the standard protocol onlythe local standard protocol of COVID19 management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
- Age above 18 years old
- Informed written consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MGAlso: Colchicinecolchicine 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 | Drug | Colchicine group |
| the standard protocol onlyAlso: the local standard protocol for COVID19the local standard protocol for COVID19 | Other | Colchicine group, Control group |
Primary outcome
Clinical status
Time frame: Two weeks
Seven-category ordinal scale: minimum 1 is the best and a maximum is 6
Pulmonary fibrosis at week 2
Time frame: Two weeks
Percent of Participants with pulmonary fibrosis
Pulmonary fibrosis at 45 days
Time frame: 45 days
Percent of Participants with pulmonary fibrosis
7 secondary outcomes
C-reactive protein
Time frame: Two weeks
Ferritin
Time frame: Two weeks
Erythrocyte sedimentation rate
Time frame: Two weeks
Lactate dehydrogenase
Time frame: Two weeks
Adverse events
Time frame: 45 days
Pulmonary function test: FVC
Time frame: 45 days
Pulmonary function test: FEV1
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 32579195Deftereos 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.
- Derived from this study: PubMed 34658014Mikolajewska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Issak principal investigator
Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 0.5 MG and the standard protocol only in people with Covid19 and Pulmonary Fibrosis Interstitial, run by ClinAmygate at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status (time frame: Two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.