ATTRACT-2: Retrospective Evaluation of Lung Pathology in Subjects With COVID-19
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
Subject treated with C21 in the VP-C21-006 trial
Subject treated with placebo in the VP-C21-006 trial
Primary Outcome Measures
- 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]
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.
- Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation
Contacts and Locations
|1||Department of Medicine, Civil Hospital and B J Medical College||Ahmadabad||Gujarat||India||380016|
|2||First Floor Clinical Research Department Rhythm Heart Institute||Vadodara||Gujarat||India||290022|
|3||Department of Medicine, Government Medical College and Hospital||Nagpur||Maharashtra||India||440003|
|4||Department of Medicine, Noble Hospitals Pvt. Ltd||Pune||Maharashtra||India|
Sponsors and Collaborators
- Vicore Pharma AB
- Study Director: Rohit Batta, MD, Vicore Pharma
Study Documents (Full-Text)None provided.
- Tornling G, et al. The angiotensin type 2 receptor agonist C21 restores respiratory function in COVID19 - a double-blind, randomized, placebo-controlled Phase 2 trial, medRxiv, 2021