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.
This study will propose Nuvastiatic™ as a new lead therapeutic agent for SARS-CoV-2, and new
insights for currently ongoing clinical trials to treat SARS-CoV-2 infections. Nuvastatic™
could be used as potential anti-coronavirus therapy that acts on the human immune system or
human cells as an immune modulator, and the other on coronavirus itself as an antiviral
agent. In terms of the human immune system, the innate immune system response plays an
important role in controlling the replication and infection of coronavirus, and interferon
gamma, interleukins, Th cells, granulocyte macrophage are expected to enhance the immune
response.
Drug: Nuvastatic
Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy
Other Name: C5OSEW5050ESA
Inclusion Criteria:
1. Male and nonpregnant female patients 18 years of age or older eligible if they had a
diagnostic specimen that was positive on RT-PCR. -
2. For Mild - Moderate cases: Subjects who show positive for nasal swab test at screening
using RT-PCR protocol for Covid 19.
3. For Severe cases - Has an 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.
4. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Female subjects who are pregnant or breastfeeding.
2. Patients who are allergic to this medicine
3. Patients allergic to content of study product
4. Patients with diabetes.
5. Patients accompanied by serious physical diseases of heart, lung, brain, etc.
6. Patients have any condition that in the judgement of the Investigators would make the
subject inappropriate for entry into this study.
7. Patients who are not able to take drugs orally.
Navin Hospital
Ghaziabad, Uttar Pradesh, India
Investigator: Dr Shruti Saini
Contact: +919911757070
Sanjay Vinaik
+91 0120-2777504
drsanjayvinaik@gmail.com
Sanjay Vinaik, Principal Investigator
Navin Hospital