Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-08-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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COVID-19 COVID-19 Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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C21

Participants treated with C21 in the VP-C21-006 trial

C21

Intervention Type DRUG

C21 was administered in the VP-C21-006 trial

Placebo

Participants treated with placebo in the VP-C21-006 trial

Placebo

Intervention Type DRUG

Placebo was administered in the VP-C21-006 trial

Interventions

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C21

C21 was administered in the VP-C21-006 trial

Intervention Type DRUG

Placebo

Placebo was administered in the VP-C21-006 trial

Intervention Type DRUG

Other Intervention Names

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Buloxibutid Compound 21

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No