NCT04409275

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

May 28, 2020

Last Update Submit

June 10, 2020

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    1 month

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted with pneumonia caused by SARS-CoV-2

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a previous diagnosis of interstitial lung disease.
  • Inability to attend review visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Department. Hospital Clinico.

Valencia, 46010, Spain

RECRUITING

Related Publications (4)

  • 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.

    PMID: 41438363DERIVED

  • 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.

    PMID: 40088077DERIVED

  • 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.

    PMID: 36096801DERIVED

  • 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.

    PMID: 34497426DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 1, 2020

Study Start

May 21, 2020

Primary Completion

December 31, 2020

Study Completion

July 31, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

ES(1)