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LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04409275
Acronym
INC-CVD-202001
Enrollment
500
Registered
2020-06-01
Start date
2020-05-21
Completion date
2021-07-31
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

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).

Interventions

None listed

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary fibrotic changes, short and medium term12 monthsTo 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 impairment6 and 12 monthsTo study the degree of lung function impairment, specifically the restrictive changes in functional capacity and diffusion alterations and its relationship with clinical variables.
Biological markers1 monthExamine the biological markers in the patients who will present this dysregulation of the curative response that will give rise to pulmonary fibrosing phenomena.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026