ATTRACT-2: Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

Sponsor

Vicore Pharma AB (Industry)

Overall Status

Completed

CT.gov ID

NCT04878913

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

9.8

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

39 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
C21 Subject treated with C21 in the VP-C21-006 trial
Placebo Subject treated with placebo in the VP-C21-006 trial

Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Investigators

Study Director: Rohit Batta, MD, Vicore Pharma

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

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

Responsible Party:

Vicore Pharma AB

ClinicalTrials.gov Identifier:

NCT04878913

Other Study ID Numbers:

VP-C21-007

First Posted:

May 10, 2021

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 25, 2022