LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

• Conditions: Pulmonary Fibrosis

• Registration Number: NCT04409275
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

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).

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Status Verified: 2020-06
• Study First Posted: 2020-06-01
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary fibrotic changes, short and medium term	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	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	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.

Trial Locations

Locations (1)

Pulmonary Department. Hospital Clinico.; 🇪🇸 Valencia, Spain