Covid-19, Hospitalized, PatIents, Nasafytol

Summary

Participation Requirements

Description

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 t...

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 efficacy 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

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