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Completed

NCT Number: NCT04878913

Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

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.

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Key information

Conditions

COVID-19 COVID-19 Pneumonia Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine, Civil Hospital and B J Medical College, Ahmedabad, Gujarat, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C21

Drug

C21 was administered in the VP-C21-006 trial

Other names: Buloxibutid, Compound 21

Placebo

Drug

Placebo was administered in the VP-C21-006 trial

Primary outcomes

  1. 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

  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

    Time frame: Up to 24 weeks after completion of VP-C21-006

Sponsors and collaborators

Lead sponsor

Vicore Pharma AB

Industry

Registry information

Official study 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

Acronym: ATTRACT-2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 10, 2021
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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