Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

Covid19 Clinical Trial

— ATTRACT-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878913
• Other study ID #: VP-C21-007
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: Vicore Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
India	Department of Medicine, Civil Hospital and B J Medical College	Ahmadabad	Gujarat
India	Department of Medicine, Government Medical College and Hospital	Nagpur	Maharashtra
India	Department of Medicine, Noble Hospitals Pvt. Ltd	Pune	Maharashtra
India	First Floor Clinical Research Department Rhythm Heart Institute	Vadodara	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Vicore Pharma AB

Country where clinical trial is conducted

India, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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