Post-COVID-19 SyndromeNCT05648734
Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis
An observational study of Post-COVID-19 Syndrome and Lung Fibrosis, run by Mansoura University at 1 site in Egypt.
Trial summary
In this study we aim to evaluate the radiological and functional changes in post-acute covid-19 pulmonary fibrosis patients in relation to anti-inflammatory and/or antifibrotic drugs prescribed during and after covid-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Lung Fibrosis
- What is being tested?
- Corticosteroids alone, Corticosteroids + Colchicine and Corticosteroids + Pirfenidone
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to 15 Sep 2022
- Phase
- Observational
- 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
Study population: Retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.
Who may be able to join
- Adult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either: Corticosteroids alone.
- Corticosteroids in combination with Colchicine.
- Corticosteroids in combination with Pirfenidone.
- Corticosteroids in combination with Colchicine and Pirfenidone.
Who cannot join
- None COVID-19 pneumonia.
- Patients with previous parenchymal lung disease.
- Patients receiving anti-fibrotic or anti-inflammatory drugs due to other chronic disease.
- Patients who received anti-fibrotic and or ant inflammatory drugs for duration and or doses less than presumed or those who reported noncompliance to treatment.
- Patients with uncontrolled comorbidities.
- Patients who develop severe intolerable side effects or derangement of liver enzymes more than 5 folds.
- Pregnant ladies with COVID-19 pneumonia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Anti-Inflammatory and Anti-Fibrotic Drugs on Post-acute COVID-19 Pulmonary Fibrosis
In this study we aim to evaluate the radiological and functional changes in post-acute covid-19 pulmonary fibrosis patients in relation to anti-inflammatory and/or antifibrotic drugs prescribed during and after covid-19 pneumonia.
Read the detailed description
This study is a prospective and retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.
Adult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either:
- Corticosteroids alone (≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge) - Group A.
- Corticosteroids in combination with Colchicine (1 mg/day for ≥ 10 days) - Group B.
- Corticosteroids in combination with Pirfenidone (267 mg TID for ≥ 14 days) - Group C.
- Corticosteroids in combination with Colchicine and Pirfenidone (for ≥ 14 days) - Group D.
Pulmonary function test: Spirometry: measurement of lung volumes and capacities (forced expiratory volume in first second FEV1, Forced Vital Capacity FVC, FEV1/FVC and FEF25/75) after 1 month and 3 months of the onset of symptoms.
Radiological scoring: Baseline High resolution CT scan of the chest will be performed at baseline, 1 month and 3 months after onset of symptoms. Chest CT-Severity Scoring (Chest CT-SS) for assessing COVID-19 burden on the initial scan will be calculated. This score uses lung opacification as a surrogate for extension of the disease in the lungs. According to the anatomic structure, the 18 segments of both lungs were divided into 20 regions, in which the posterior apical segment of the left upper lobe was subdivided into apical and posterior segmental regions, whereas the anteromedial basal segment of the left lower lobe was subdivided into anterior and basal segmental regions. The lung opacities in all the 20 lung regions were subjectively evaluated on chest CT images using a system attributing score of 0, 1, and 2 if parenchymal opacification involved 0%, less than 50%, or equal to or more than 50% of each region, respectively. The CT-SS was defined as the sum of the individual scores in the 20 lung segment regions, which may range from 0 to 40 points
- Conditions
- Post-COVID-19 Syndrome, Lung Fibrosis
- Being tested
- Corticosteroids alone, Corticosteroids + Colchicine, Corticosteroids + Pirfenidone, Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids aloneDrug
Also called Solupred, Disperlone, Methabiogen, Epicopred
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge)
Corticosteroids + ColchicineDrug
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days)
Corticosteroids + PirfenidoneDrug
Also called Corticosteroids + Pirfinix
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)
Corticosteroids + Colchicine + Pirfenidone for ≥ 14 daysDrug
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients received Corticosteroids only Receives: Drug: Corticosteroids alone | |
| Group B | Patients received Corticosteroids in combination with Colchicine Receives: Drug: Corticosteroids + Colchicine | |
| Group C | Patients received Corticosteroids in combination with Pirfenidone Receives: Drug: Corticosteroids + Pirfenidone | |
| Group D | Patients received Corticosteroids in combination with Colchicine and Pirfenidone Receives: Drug: Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Functions Test
Change in FVC from 1 month to 3 months follow up after hospital discharge
Measured: 8 weeks
Radiological scoring
Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after hospital discharge compared to baseline CT Chest scan
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start10 Mar 2022
- Primary completion15 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amina Abdel Maksoud, MD, Study director, Mansoura University, Faculty of MedicineDalia Fahmy, MD, Study director, Mansoura University, Faculty of MedicineAida Yousef, MD, Study director, Mansoura University, Faculty of MedicineMohamed Tohlob, MD, Study director, Mansoura University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648734
- Sponsor's protocol ID
- MD.21.09.526 - 2021/09/12
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous'd individual data will be available with the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anti-Inflammatory and Anti-Fibrotic Drugs on Post-acute COVID-19 Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05648734
- Acronym / sponsor ID
- MD.21.09.526 - 2021/09/12
- Conditions
- Post-COVID-19 Syndrome, Lung Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 13 Dec 2022 (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.
In this study we aim to evaluate the radiological and functional changes in post-acute covid-19 pulmonary fibrosis patients in relation to anti-inflammatory and/or antifibrotic drugs prescribed during and after covid-19 pneumonia.
Detailed description
This study is a prospective and retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.
Adult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either:
- Corticosteroids alone (≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge) - Group A.
- Corticosteroids in combination with Colchicine (1 mg/day for ≥ 10 days) - Group B.
- Corticosteroids in combination with Pirfenidone (267 mg TID for ≥ 14 days) - Group C.
- Corticosteroids in combination with Colchicine and Pirfenidone (for ≥ 14 days) - Group D.
Pulmonary function test: Spirometry: measurement of lung volumes and capacities (forced expiratory volume in first second FEV1, Forced Vital Capacity FVC, FEV1/FVC and FEF25/75) after 1 month and 3 months of the onset of symptoms.
Radiological scoring: Baseline High resolution CT scan of the chest will be performed at baseline, 1 month and 3 months after onset of symptoms. Chest CT-Severity Scoring (Chest CT-SS) for assessing COVID-19 burden on the initial scan will be calculated. This score uses lung opacification as a surrogate for extension of the disease in the lungs. According to the anatomic structure, the 18 segments of both lungs were divided into 20 regions, in which the posterior apical segment of the left upper lobe was subdivided into apical and posterior segmental regions, whereas the anteromedial basal segment of the left lower lobe was subdivided into anterior and basal segmental regions. The lung opacities in all the 20 lung regions were subjectively evaluated on chest CT images using a system attributing score of 0, 1, and 2 if parenchymal opacification involved 0%, less than 50%, or equal to or more than 50% of each region, respectively. The CT-SS was defined as the sum of the individual scores in the 20 lung segment regions, which may range from 0 to 40 points
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Corticosteroids alonePatients received Corticosteroids only |
| Group B | – | Drug: Corticosteroids + ColchicinePatients received Corticosteroids in combination with Colchicine |
| Group C | – | Drug: Corticosteroids + PirfenidonePatients received Corticosteroids in combination with Pirfenidone |
| Group D | – | Drug: Corticosteroids + Colchicine + Pirfenidone for ≥ 14 daysPatients received Corticosteroids in combination with Colchicine and Pirfenidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.
Key inclusion criteria (4 listed)
- Adult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either: Corticosteroids alone.
- Corticosteroids in combination with Colchicine.
- Corticosteroids in combination with Pirfenidone.
- Corticosteroids in combination with Colchicine and Pirfenidone.
Key exclusion criteria (7 listed)
- None COVID-19 pneumonia.
- Patients with previous parenchymal lung disease.
- Patients receiving anti-fibrotic or anti-inflammatory drugs due to other chronic disease.
- Patients who received anti-fibrotic and or ant inflammatory drugs for duration and or doses less than presumed or those who reported noncompliance to treatment.
- Patients with uncontrolled comorbidities.
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 |
|---|---|---|
| Corticosteroids aloneAlso: Solupred, Disperlone, Methabiogen, Epicopred(≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge) | Drug | Group A |
| Corticosteroids + Colchicine(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) | Drug | Group B |
| Corticosteroids + PirfenidoneAlso: Corticosteroids + Pirfinix(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days) | Drug | Group C |
| Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days) | Drug | Group D |
Primary outcome
Pulmonary Functions Test
Time frame: 8 weeks
Change in FVC from 1 month to 3 months follow up after hospital discharge
Radiological scoring
Time frame: 8 weeks
Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after hospital discharge compared to baseline CT Chest scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Yes. Anonymous'd individual data will be available with the corresponding author on reasonable request
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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.
Amina Abdel Maksoud, MD study director
Mansoura University, Faculty of Medicine
Dalia Fahmy, MD study director
Mansoura University, Faculty of Medicine
Aida Yousef, MD study director
Mansoura University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-COVID-19 Syndrome and Lung Fibrosis, run by Mansoura University 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 13 Dec 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulmonary Functions Test (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022.