COVID-19, COVID-19 Pneumonia
Conditions
Brief summary
Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.
Detailed description
The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion. HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.
Interventions
DRUGC21
C21 was administered in the VP-C21-006 trial
DRUGPlacebo
Placebo was administered in the VP-C21-006 trial
Sponsors
Vicore Pharma AB
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP) * Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.
Exclusion criteria
* 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 | Description |
|---|---|---|
| Averaged total lung score for both lungs percent measured by per lung percent scores | Up to 24 weeks after completion of VP-C21-006 | Based on ground glass opacity, reticulation, band opacity, fibrosis, and consolidation, on HRCT |
| Change from baseline in percent lung involvement measured totally (averaged total lung score for both lungs percent) and by each of ground glass opacity, reticulation, band opacity, fibrosis, and consolidation on follow-up HRCT | Up to 24 weeks after completion of VP-C21-006 | — |
Countries
India
Outcome results
None listed