- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409275
LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION (INC-CVD-202001)
June 10, 2020 updated by: Fundación para la Investigación del Hospital Clínico de Valencia
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Valencia, Spain, 46010
- Recruiting
- Pulmonary Department. Hospital Clinico.
-
Contact:
- Jaime Signes-Costa, MD, PhD
- Phone Number: 973904 34 961973500
- Email: jaimesignescosta@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted with pneumonia caused by SARS-CoV-2
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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.
|
6 and 12 months
|
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.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2020
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
July 31, 2021
Study Registration Dates
First Submitted
May 28, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 10, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INC-CVD-2020-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Fibrosis
-
St. Antonius HospitalZonMw: The Netherlands Organisation for Health Research and Development; Boeringer...RecruitingPulmonary Fibrosis Idiopathic FamilialNetherlands
-
Wake Forest University Health SciencesMayo Clinic; The University of Texas Health Science Center at San AntonioCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceRecruitingIdiopathic Pulmonary Fibrosis | Pulmonary Disease | Pulmonary MedicineFrance
-
Sheba Medical CenterUnknownIDIOPATHIC PULMONARY FIBROSISIsrael
-
Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
-
University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
-
Centre Hospitalier Universitaire de NiceRecruitingPulmonary Disease, Chronic Obstructive | Interstitial Pulmonary FibrosisFrance
-
Boehringer IngelheimNot yet recruitingIdiopathic Pulmonary Fibrosis | Progressive Pulmonary Fibrosis