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Clinical Trials/NCT04409275
NCT04409275
Unknown
Not Applicable

STUDY OF THE APPEARANCE OF LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

Fundación para la Investigación del Hospital Clínico de Valencia1 site in 1 country500 target enrollmentMay 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Fibrosis
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Enrollment
500
Locations
1
Primary Endpoint
Pulmonary fibrotic changes, short and medium term
Last Updated
5 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
May 21, 2020
End Date
July 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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