Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

Completed

• Conditions: COVID-19; COVID-19 Pneumonia
• Interventions: Drug: C21; Drug: Placebo

• Registration Number: NCT04878913
• Lead Sponsor: Vicore Pharma AB

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.

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 Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Study Start: 2021-06-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C21	C21	Participants treated with C21 in the VP-C21-006 trial
Placebo	Placebo	Participants treated with placebo in the VP-C21-006 trial

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

First Floor Clinical Research Department Rhythm Heart Institute; 🇮🇳 Vadodara, Gujarat, India

Department of Medicine, Government Medical College and Hospital; 🇮🇳 Nagpur, Maharashtra, India

Department of Medicine, Civil Hospital and B J Medical College; 🇮🇳 Ahmadabad, Gujarat, India

Department of Medicine, Noble Hospitals Pvt. Ltd; 🇮🇳 Pune, Maharashtra, India