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.
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.
Study Type
OBSERVATIONAL
Enrollment
35
Department of Medicine, Civil Hospital and B J Medical College
Ahmedabad, Gujarat, India
First Floor Clinical Research Department Rhythm Heart Institute
Vadodara, Gujarat, India
Department of Medicine, Government Medical College and Hospital
Nagpur, Maharashtra, India
Department of Medicine, Noble Hospitals Pvt. Ltd
Pune, Maharashtra, India
Averaged total lung score for both lungs percent measured by per lung percent scores
Based on ground glass opacity, reticulation, band opacity, fibrosis, and consolidation, on HRCT
Time frame: Up to 24 weeks after completion of VP-C21-006
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
Time frame: Up to 24 weeks after completion of VP-C21-006
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