COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
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.
2. Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy)
3. Group C: no Sentinox treatment
only the standard therapy will be performed.
The allocation of the patient in one of the three study arms will be performed sequentially by the principal investigator or delegates in
Sponsors
Applied Pharma Research (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/07/2021: 1. Patient informed consent form (ICF) signed 2. Aged =18 and =64 years at the time of the signature of ICF 3. 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 4. Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version as of 27/05/2020). In the study will be enrolled COVID-19 patient with RT-PCR Ct value =30 for =2 genes out of 4, at the first swab. 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) 5. Onset of symptoms from not more than 2/3 days Previous inclusion criteria: 1. Patient informed consent form (ICF) signed 2. Aged =18 and <64 years at the time of the signature of ICF 3. 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 4. Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version as of 27/05/2020). In the study will be enrolled COVID-19 patient with RT-PCR Ct value <30 for =2 genes out of 4, at the first swab. 5. Onset of symptoms from not more than 2/3 days
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 29/07/2021: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. 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 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 7. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 8. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 9. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 10. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 11. Prior hospitalization for COVID-19 12. Positive pregnancy test or breastfeeding woman 13. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 14. History of severe drug and/or food allergies and/or known allergies to the trial product or its components 15. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient Previous exclusion criteria: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. 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 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine) 7. Vaccination with COVID-19 vaccine 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 12. Prior hospitalization for COVID-19 13. Positive pregnancy test or breastfeeding woman 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 15. History of severe dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Viral load in COVID-19 patients measured using quantitative swab test with RT-PCR at baseline, 1, 2, 3, 4, 5, 6, 10, and 21 days (three swabs daily on day 1 and 2, and one swab daily on other days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/03/2022: 1. Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load in nasal fluids in mild COVID-19 patients stratifying the results according to the initial at day 1, 2, 3, 4, 5, 6, 10, and 21 2. Time profile of Sentinox to affect the profile of viral load analysing the subjects’ negativization (expressed as number of negativized patients) at day 1, 2, 3, 4, 5, 6, 10, and 21 3. Time profile of Sentinox to affect the profile of viral load analysing the infectiousness of the patients (expressed as number of infective patients) at day 1, 2, 3, 4, 5, 6, 10, and 21 4. Evaluating the time profile of Sentinox by the profile of COVID-19 viral load measured using quantitative swab test with RT-PCR at baseline, 1, 2, 3, 4, 5, 6, 10, and 21 days (three swabs daily on day 1 and 2, and one swab daily on other days) 5. Evaluating time profile of Sentinox in terms of the duration of clinical features of COVID-19 measured using an ad hoc questionnaire between baseline and 21 days 6. Tolerability of Sentinox measured using a visual analogue scale (VAS) for overall patient treatment tolerance at 6 days 7. Patient satisfaction of Sentinox measured using a 5-point Likert Scale for patient satisfaction at 6 days 8. Safety of Sentinox measured using adverse events recorded in the patient diary between 1 and 5 days and clinical examination at baseline, 1, 2, 3, 4, 5, 6, 10, and 21 days _____ Previous secondary outcome measures: 1. Evaluating the time profile of Sentinox by the profile of COVID-19 viral load measured using quantitative swab test with RT-PCR at baseline, 1, 2, 3, 4, 5, 6, 10, and 21 days (three swabs daily on day 1 and 2, and one swab daily on other days) 2. Evaluating the time profile of Sentinox by the duration | — |
Countries
Italy
Outcome results
None listed