Status:
COMPLETED
Study on the Performance and Safety of Sentinox in COVID-19 Patients
Lead Sponsor:
APR Applied Pharma Research s.a.
Conditions:
COVID-19 (SARS-CoV-2 Infection)
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This is a single-center, randomized, controlled, open-label, pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients. The study will...
Eligibility Criteria
Inclusion
- Patient Informed consent form (ICF) signed;
- M \& F Aged ≥ 18 years and ≤ 64 years at the time of the signature of ICF;
- Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact;
- Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version of 27 May 2020). In the study COVID-19 patient with RT-PCR Ct value ≤ 30 for at least 2 genes out of 4, at the first swab will be enrolled. The enrollment of COVID-19 vaccinated patients will be allowed if they will present a "clinical vaccination failure", defined according to the indications reported in the "Global Manual on Surveillance of AE Following Immunization" (WHO guidelines).
- Onset of symptoms from not more than 2/3 days
Exclusion
- Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases);
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values;
- Immune system illnesses;
- Known drug and/or alcohol abuse;
- Individuals who are cognitively impaired and/or who are unable to give informed consent;
- Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19;
- Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day;
- Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 hours;
- Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV);
- Concurrent or planned treatment with other agents with actual or possible direct antiviral activity;
- Prior hospitalization for COVID-19;
- Positive pregnancy test or breastfeeding woman;\*
- Known hypersensitivity to the study treatment, its metabolites, or formulation excipient;
- History of severe drug and / or food allergies and / or known allergies to the trial product or its components;
- Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04909996
Start Date
May 20 2021
End Date
November 30 2021
Last Update
July 27 2022
Active Locations (1)
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1
Ospedale Policlinico San Martino IRCCS
Genova, Italy, 16132