LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

NCT ID: NCT04409275

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Pulmonary Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients with a previous diagnosis of interstitial lung disease.
* Inability to attend review visits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pulmonary Department. Hospital Clinico.

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Jaime Signes-Costa, MD, PhD

Role: primary

34 961973500 ext. 973904

References

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Botello-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.

Reference Type DERIVED
PMID: 40088077 (View on PubMed)

Tarraso 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.

Reference Type DERIVED
PMID: 36096801 (View on PubMed)

Safont 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.

Reference Type DERIVED
PMID: 34497426 (View on PubMed)

Other Identifiers

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INC-CVD-2020-01

Identifier Type: -

Identifier Source: org_study_id

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