50 patients (25 per arm) infected with COVID-19 and hospitalized (depending on the progress of the pandemic and therefore the presence of COVID-19 patients, this number could reach 100 (50 per arm)). The first ten sentinel patients will be monitored at the safety level before enrolling the rest of the participants.~The effect and safety of NASAFYTOL® will be evaluated using the following outcome measures:~Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is no clinical or virological evidence of infection, 1 is no limitation of activities, 2 is limitation of activities, 3 is hospitalized, no oxygen therapy, 4 is oxygen by mask or nasal prongs, 5 is non-invasive ventilation or high-flow oxygen, 6 is intubation and mechanical ventilation, 7 is ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation), and 8 is death.~Time to a 1-point decrease~Score at 14 days (or at hospital leave if <14 days) post randomization~Duration (days) of hospitalization~In-hospital mortality~Temperature (fever):~Time to resolution of fever for at least 48 hours without antipyretics for 48 hours - Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)~Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)~Need of oxygen therapy~Tolerance as defined by the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)~Compliance using the pill count~Blood test:~C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial~Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization~Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.~Optional outcome measures will be perform if data is available from routine practice:~Blood tests between inclusion and end of trial~Radiological response - Thoracic CT scan or Chest XR~Oxygenation PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) :~Time to improvement (TBD) in oxygenation for at least 48 hours~Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)~Time until negative RT-PCR
The objective of this study is to evaluate the effect and safety of NASAFYTOL® on COVID-19 positive hospitalized patients as a supportive supplementation to standard-of-care in improving clinical parameters safely during hospital admission (maximum 14 days).~The study is a standard-of-care comparative, open, parallel two-arms and randomized trial in 50 adult patients positive to COVID-19 infection and hospitalized. It will be monocentric but may be extended to several investigation sites (multicentric) depending on the evolution of the epidemic within the hospitals.