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

August 29, 2024 updated by: Vicore Pharma AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmadabad, Gujarat, India, 380016
        • Department of Medicine, Civil Hospital and B J Medical College
      • Vadodara, Gujarat, India, 290022
        • First Floor Clinical Research Department Rhythm Heart Institute
    • Maharashtra
      • Nagpur, Maharashtra, India, 440003
        • Department of Medicine, Government Medical College and Hospital
      • Pune, Maharashtra, India
        • Department of Medicine, Noble Hospitals Pvt. Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who were previously hospitalized with COVID-19 and enrolled in the VP-C21-006 trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
C21
Participants treated with C21 in the VP-C21-006 trial
Drug: C21
C21 was administered in the VP-C21-006 trial
Other Names:
  • Buloxibutid
  • Compound 21
Placebo
Participants treated with placebo in the VP-C21-006 trial
Drug: Placebo
Placebo was administered in the VP-C21-006 trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Averaged total lung score for both lungs percent measured by per lung percent scores
Time Frame: Up to 24 weeks after completion of VP-C21-006
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
Time Frame: Up to 24 weeks after completion of VP-C21-006
Up to 24 weeks after completion of VP-C21-006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vicore Pharma AB

Investigators

  • Study Director: Rohit Batta, MD, Vicore Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

August 23, 2021

Study Completion (Actual)

August 23, 2021

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-C21-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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