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To study lung fuction and residual lung damage in COVID 19 patients who recover from the infections.

Not yet recruiting
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
Inclusion Criteria
  • 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.
Exclusion Criteria

Patients not willing to consent or unable to come for follow-up.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
4.SGRQ: Respirtory symptoms, problems, treatment & activities4 to 6 weeks, 3 months, 6 months
2.6 Min walk test parameters: 6 min walk distance, Distance Saturation Product, Lowest SPO2, Dyspnea Borg scale4 to 6 weeks, 3 months, 6 months
1.Lung function paramenters: FEV1, FVC, TLC, RV, DLco, DLco/VA4 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
NameTimeMethod

Trial Locations

Locations (1)

Christian Medical College

🇮🇳

Vellore, TAMIL NADU, India

Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Dr DJ Christopher
Principal investigator
09443306573
djchris@cmcvellore.ac.in

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