The Non-interventional, retrospective, review to know effect of C21 on lung pathology.
Not Applicable
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/033948
- Lead Sponsor
- Vicore Pharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Written informed consent
2) Previously included in the VP-C21-006 trial and received at least one dose of IMP
3) Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.
Exclusion Criteria
1) Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Averaged total lung score for both lungs (%) measured by per lung % scores based on ground glass opacity, reticulation, band opacity, fibrosis and consolidation, on HRCT performed up to 24 weeks after completion of VP-C21-006Timepoint: Baseline <br/ ><br>24 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in % lung involvement measured totally (averaged total lung score for both lungs %) and by each of ground glass opacity, reticulation, band opacity, fibrosis and consolidation on follow-up HRCT performed up to 24 weeks after completion of VP-C21-006.Timepoint: Within 28 days prior to subject�s participation in VP-C21-006 <br/ ><br> <br/ ><br>Up to 24 weeks after completion of VP-C21-006;Further categorisation and evaluation of lung involvement as assessed by HRCT reflecting predominant patterns, distribution, severity of disease and time courseTimepoint: Within 28 days prior to subject�s participation in VP-C21-006 <br/ ><br> <br/ ><br>Up to 24 weeks after completion of VP-C21-006