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

V

Vicore Pharma

Status

Completed

Conditions

COVID-19
COVID-19 Pneumonia

Treatments

Drug: Placebo
Drug: C21

Study type

Observational

Funder types

Industry

Identifiers

NCT04878913
VP-C21-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

C21
Description:
Participants treated with C21 in the VP-C21-006 trial
Treatment:
Drug: C21
Placebo
Description:
Participants treated with placebo in the VP-C21-006 trial
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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