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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C21 | Participants treated with C21 in the VP-C21-006 trial |
| |
| Placebo | Participants treated with placebo in the VP-C21-006 trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C21 | Drug | C21 was administered in the VP-C21-006 trial |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Up to 24 weeks after completion of VP-C21-006 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who were previously hospitalized with COVID-19 and enrolled in the VP-C21-006 trial.
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Batta, MD | Vicore Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Civil Hospital and B J Medical College | Ahmedabad | Gujarat | 380016 | India | ||
| First Floor Clinical Research Department Rhythm Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711730 | compound 21 |
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| Placebo | Drug | Placebo was administered in the VP-C21-006 trial |
|
| Vadodara |
| Gujarat |
| 290022 |
| India |
| Department of Medicine, Government Medical College and Hospital | Nagpur | Maharashtra | 440003 | India |
| Department of Medicine, Noble Hospitals Pvt. Ltd | Pune | Maharashtra | India |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |