To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients.
Status:
Recruiting
Trial end date:
2020-09-30
Target enrollment:
Participant gender:
Summary
A two arm open label multi-centered randomized interventional trial is proposed to assess
aspects of safety and efficacy of Nuvastatic™ (Serial No: C5OSEW5050ESA) . Two parallel
groups of (1:1) ratio comparing Nuvastatic™ versus standard care will be conducted on
patients on oxygen saturation (SaO2) of 94% or less while they are breathing ambient air or a
ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2)
(PaO2:FiO2) at or below 300 mg Hg.
Primary Outcome Measures: time to clinical improvement, defined as the time from
randomization to an improvement of two points (from the status at randomization) on a
seven-category ordinal scale or live discharge from the hospital, whichever comes first.
Secondary Outcome Measures: Clinical status as assessed with the seven-category ordinal scale
on days 7 and 14, mortality at day 28.
1. The duration of mechanical ventilation.
2. The duration of hospitalization in survivors.
3. The time (in days) from treatment initiation to death.
4. Virologic measures included the proportions with viral RNA detection over time and viral
RNA titer area under-curve (auc) measurements.