Retrospective Evaluation of Lung Pathology in Subjects With COVID-19
ATTRACT-2
Non-interventional, Retrospective, Multicenter, Follow-up Study Evaluating the Effect of C21 on Lung Pathology in Subjects Previously Hospitalized With COVID-19 and Enrolled in the VP-C21-006 Trial
1 other identifier
observational
35
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2021
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
July 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2021
CompletedSeptember 4, 2024
August 1, 2024
2 months
May 4, 2021
August 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
C21
Participants treated with C21 in the VP-C21-006 trial
Placebo
Participants treated with placebo in the VP-C21-006 trial
Interventions
Eligibility Criteria
Subjects who were previously hospitalized with COVID-19 and enrolled in the VP-C21-006 trial.
You may qualify if:
- 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.
You may not qualify if:
- Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vicore Pharma ABlead
Study Sites (4)
Department of Medicine, Civil Hospital and B J Medical College
Ahmedabad, Gujarat, 380016, India
First Floor Clinical Research Department Rhythm Heart Institute
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
Related Publications (1)
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
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rohit Batta, MD
Vicore Pharma
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 10, 2021
Study Start
July 7, 2021
Primary Completion
August 23, 2021
Study Completion
August 23, 2021
Last Updated
September 4, 2024
Record last verified: 2024-08