To study lung fuction and residual lung damage in COVID 19 patients who recover from the infections.
- Conditions
- Certain infectious and parasitic diseases, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/10/037090
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Since the initial reports of the recent new COVID-19 virus infection (SARS-CoV2) in December 2019, the outbreak has rapidly spread and escalated resulting in this disease being formally declared a pandemic on 11 March 2020 by the World Health Organization.
Transmission dynamics are currently evolving and high person-to-person spread has been confirmed in community and healthcare settings in China and other countries.
Pneumonia appears to be the most frequent serious manifestation of infection and Acute respiratory distress syndrome (ARDS) is the major complication in patients, with high fatality rate. These are likely to heal with fibrosis and result in residual lung damage and lung function impairment. This has not been well studied. When the study was conceived, only one study in China has tested lung function in a small number of subjects, subsequently few others had published their findings. There are no studies from India. We propose to evaluate these patients with lung function testing, exercise capacity, lung scarring as seen by imaging and health related quality of life
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 400
- Adult inpatients (more than 18 years and older) with positive SARS-CoV-2 RNA detection (throat swab) results and diagnosed with COVID-19 2.
- Willing to sign informed consent.
Patients not willing to consent or unable to come for follow-up.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 4.SGRQ: Respirtory symptoms, problems, treatment & activities 4 to 6 weeks, 3 months, 6 months 2.6 Min walk test parameters: 6 min walk distance, Distance Saturation Product, Lowest SPO2, Dyspnea Borg scale 4 to 6 weeks, 3 months, 6 months 1.Lung function paramenters: FEV1, FVC, TLC, RV, DLco, DLco/VA 4 to 6 weeks, 3 months, 6 months 3.CXR/HRCT: Fibrosis, Consolidation, bronchiectasis etc. 4 to 6 weeks, 3 months, 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaDr DJ ChristopherPrincipal investigator09443306573djchris@cmcvellore.ac.in