Pulmonary FibrosisINC-CVD-202001NCT04409275
LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION
An observational study of Pulmonary Fibrosis, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with SARS-CoV-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 21 May 2020to 31 Jul 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with pneumonia caused by SARS-CoV-2
Who may be able to join
- Patients admitted for bilateral pneumonia caused by SARS-CoV-2 (confirmed by PCR).
- Age over 18 years.
- Acceptance of informed consent.
- Life expectancy over 1 year.
Who cannot join
- Patients with a previous diagnosis of interstitial lung disease.
- Inability to attend review visits.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pulmonary Department. Hospital Clinico.
Valencia, 46010
Jaime Signes-Costa, MD, PhD, 34 961973500 ext. 973904, jaimesignescosta@gmail.com
About this study
Official title: STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION
Prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with SARS-CoV-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge.
Read the detailed description
The project consists of a prospective, observational, multicenter study that will evaluate changes in lung function (forced spirometry, measurement of static lung volumes using plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with pneumonia will present. caused by SARS-CoV-2 according to the level of severity at 4, 12, 26 and 52 weeks after discharge from hospital. Restrictive pulmonary abnormalities will be confirmed by imaging tests (high resolution chest CT).
- Conditions
- Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary fibrotic changes, short and medium term
To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2
Measured: 12 months
Degree of lung function impairment
To study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.
Measured: 6 and 12 months
Biological markers
Examine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start21 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409275
- Sponsor's protocol ID
- INC-CVD-2020-01
- Acronym
- INC-CVD-202001
- Status last verified
- Jun 2020
- First submitted
- 28 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Villaescusa C, Tarraso Castillo J, Martinez-Pitarch D, Riesco Miranda JA, Garcia-Castillo E, Gotera Rivera C, Carrasco Hernandez L, Sobradillo Ecenarro P, Signes-Costa J, Naval Sendra E, Callejas Gonzalez FJ, Yordi Leon A, Vigil Gimenez L, Nunez Fernandez M, Palop Cervera M, Carbonell-Asins JA, Agusti A; Field Investigators. Predictors of Progression in Pre-COPD: The 3P Study Rationale and Design. Open Respir Arch. 2025 Nov 17;8(1):100519. doi: 10.1016/j.opresp.2025.100519. eCollection 2026 Jan-Mar.
PubMed 41438363Botello-Marabotto M, Tarraso J, Mulet A, Presa-Fernandez L, Fernandez-Fabrellas E, Portal JAR, Ros JA, Lozano-Vicente D, Bernardos A, Martinez-Bisbal MC, Martinez-Manez R, Signes-Costa J. Metabolomic Biomarkers of Pulmonary Fibrosis in COVID-19 Patients One Year After Hospital Discharge. J Med Virol. 2025 Mar;97(3):e70289. doi: 10.1002/jmv.70289.
PubMed 40088077Tarraso J, Safont B, Carbonell-Asins JA, Fernandez-Fabrellas E, Sancho-Chust JN, Naval E, Amat B, Herrera S, Ros JA, Soler-Cataluna JJ, Rodriguez-Portal JA, Andreu AL, Marin M, Rodriguez-Hermosa JL, Gonzalez-Villaescusa C, Soriano JB, Signes-Costa J; COVID-FIBROTIC study team. Lung function and radiological findings 1 year after COVID-19: a prospective follow-up. Respir Res. 2022 Sep 12;23(1):242. doi: 10.1186/s12931-022-02166-8.
PubMed 36096801Safont B, Tarraso J, Rodriguez-Borja E, Fernandez-Fabrellas E, Sancho-Chust JN, Molina V, Lopez-Ramirez C, Lope-Martinez A, Cabanes L, Andreu AL, Herrera S, Lahosa C, Ros JA, Rodriguez-Hermosa JL, Soriano JB, Moret-Tatay I, Carbonell-Asins JA, Mulet A, Signes-Costa J. Lung Function, Radiological Findings and Biomarkers of Fibrogenesis in a Cohort of COVID-19 Patients Six Months After Hospital Discharge. Arch Bronconeumol. 2022 Feb;58(2):142-149. doi: 10.1016/j.arbres.2021.08.014. Epub 2021 Sep 3.
PubMed 34497426
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION
- ClinicalTrials.gov ID
- NCT04409275
- Acronym / sponsor ID
- INC-CVD-202001 / INC-CVD-2020-01
- Conditions
- Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 1 Jun 2020 (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.
Prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with SARS-CoV-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge.
Detailed description
The project consists of a prospective, observational, multicenter study that will evaluate changes in lung function (forced spirometry, measurement of static lung volumes using plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with pneumonia will present. caused by SARS-CoV-2 according to the level of severity at 4, 12, 26 and 52 weeks after discharge from hospital. Restrictive pulmonary abnormalities will be confirmed by imaging tests (high resolution chest CT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with pneumonia caused by SARS-CoV-2
Key inclusion criteria (4 listed)
- Patients admitted for bilateral pneumonia caused by SARS-CoV-2 (confirmed by PCR).
- Age over 18 years.
- Acceptance of informed consent.
- Life expectancy over 1 year.
Key exclusion criteria (2 listed)
- Patients with a previous diagnosis of interstitial lung disease.
- Inability to attend review visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary fibrotic changes, short and medium term
Time frame: 12 months
To analyze the number of patients who will develop pulmonary fibrotic changes, in the short and medium term, after surviving a bilateral pulmonary infection by SARS-CoV-2
Degree of lung function impairment
Time frame: 6 and 12 months
To study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.
Biological markers
Time frame: 1 month
Examine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 41438363Gonzalez-Villaescusa C, Tarraso Castillo J, Martinez-Pitarch D, Riesco Miranda JA, Garcia-Castillo E, Gotera Rivera C, Carrasco Hernandez L, Sobradillo Ecenarro P, Signes-Costa J, Naval Sendra E, Callejas Gonzalez FJ, Yordi Leon A, Vigil Gimenez L, Nunez Fernandez M, Palop Cervera M, Carbonell-Asins JA, Agusti A; Field Investigators. Predictors of Progression in Pre-COPD: The 3P Study Rationale and Design. Open Respir Arch. 2025 Nov 17;8(1):100519. doi: 10.1016/j.opresp.2025.100519. eCollection 2026 Jan-Mar.
- Derived from this study: PubMed 40088077Botello-Marabotto M, Tarraso J, Mulet A, Presa-Fernandez L, Fernandez-Fabrellas E, Portal JAR, Ros JA, Lozano-Vicente D, Bernardos A, Martinez-Bisbal MC, Martinez-Manez R, Signes-Costa J. Metabolomic Biomarkers of Pulmonary Fibrosis in COVID-19 Patients One Year After Hospital Discharge. J Med Virol. 2025 Mar;97(3):e70289. doi: 10.1002/jmv.70289.
- Derived from this study: PubMed 36096801Tarraso J, Safont B, Carbonell-Asins JA, Fernandez-Fabrellas E, Sancho-Chust JN, Naval E, Amat B, Herrera S, Ros JA, Soler-Cataluna JJ, Rodriguez-Portal JA, Andreu AL, Marin M, Rodriguez-Hermosa JL, Gonzalez-Villaescusa C, Soriano JB, Signes-Costa J; COVID-FIBROTIC study team. Lung function and radiological findings 1 year after COVID-19: a prospective follow-up. Respir Res. 2022 Sep 12;23(1):242. doi: 10.1186/s12931-022-02166-8.
- Derived from this study: PubMed 34497426Safont B, Tarraso J, Rodriguez-Borja E, Fernandez-Fabrellas E, Sancho-Chust JN, Molina V, Lopez-Ramirez C, Lope-Martinez A, Cabanes L, Andreu AL, Herrera S, Lahosa C, Ros JA, Rodriguez-Hermosa JL, Soriano JB, Moret-Tatay I, Carbonell-Asins JA, Mulet A, Signes-Costa J. Lung Function, Radiological Findings and Biomarkers of Fibrogenesis in a Cohort of COVID-19 Patients Six Months After Hospital Discharge. Arch Bronconeumol. 2022 Feb;58(2):142-149. doi: 10.1016/j.arbres.2021.08.014. Epub 2021 Sep 3.
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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.
Pulmonary Department. Hospital Clinico.
Valencia, Spain
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 Pulmonary Fibrosis, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 2 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 11 Jun 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary fibrotic changes, short and medium term (time frame: 12 months). 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 NCT04409275, which also lists 4 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 11 Jun 2020.