LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

Pulmonary Fibrosis Clinical Trial

— INC-CVD-202001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409275
• Other study ID #: INC-CVD-2020-01
• Status: Recruiting
• Start date: May 21, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2020
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Fibrosis

Locations

Country	Name	City	State
Spain	Pulmonary Department. Hospital Clinico.	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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