Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Vicore Pharma AB
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 subjectââ?¬â?¢s participation in VP-C21-006 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 subjectââ?¬â?¢s participation in VP-C21-006 Up to 24 weeks after completion of VP-C21-006 | — |
Countries
India
Contacts
Public ContactMr Gajendra Chanchu
QED Clinical Services India Private Limited
Outcome results
None listed