Covid19 Clinical Trial
Official title:
Phase Ib Controlled Exploratory Trial for Treatment of Fibrosing Interstitial Lung Disease Patients Secondary to SARS-CoV-2 Infection With IN01 Vaccine (COVINVAC)
Methodology:
This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial
in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection.
Patients who give informed consent will be screened for enrolment in the study. Patients that
meet the eligibility criteria will be enrolled and randomly allocated in the control arm
(best standard of care) or the experimental arm (best standard of care plus IN01
vaccination).
The patients enrolled in the control arm of the study will receive standard of care.
The primary endpoint is safety, measured by the Frequency and severity of AEs graded
according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria.
Biochemical and blood count alterations will be also monitored. Safety will be defined based
on the frequency and severity of adverse events (AEs) throughout the patient's participation
in the study comparing between control and experimental arms.
Efficacy will be measured as function of the annual rate of decline in the Forced Vital
Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation
levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52.
High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12,
24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease.
A translational substudy will be included.
Objectives:
Primary Objective
● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients
that develop fibrotic lung syndrome after infection.
Secondary Objectives
- To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality
of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung
disease after infection.
- To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of
action.
n/a
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