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

Sponsor
Vicore Pharma AB (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04878913
Collaborator
(none)
39
Enrollment
4
Locations
4
Anticipated Duration (Months)
9.8
Patients Per Site
2.5
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 DiseaseIntervention/TreatmentPhase

    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
    Anticipated Study Completion Date :
    Sep 30, 2021

    Arms and Interventions

    ArmIntervention/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

    1. 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

    2. 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

    SiteCityStateCountryPostal Code
    1Department of Medicine, Civil Hospital and B J Medical CollegeAhmadabadGujaratIndia380016
    2First Floor Clinical Research Department Rhythm Heart InstituteVadodaraGujaratIndia290022
    3Department of Medicine, Government Medical College and HospitalNagpurMaharashtraIndia440003
    4Department of Medicine, Noble Hospitals Pvt. LtdPuneMaharashtraIndia

    Sponsors and Collaborators

    • Vicore Pharma AB

    Investigators

    • Study Director: Rohit Batta, MD, Vicore Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Vicore Pharma AB
    ClinicalTrials.gov Identifier:
    NCT04878913
    Other Study ID Numbers:
    • VP-C21-007
    First Posted:
    May 10, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021