To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients.

An Open Label Proof of Concept Study to Assess Aspects of Safety and Efficacy of Nuvastatic™ (C5OSEW5050ESA) as an Immunomodulator Adjuvant Therapy to the Standard Care of Treatment in Covid 19 Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Drug: Nuvastatic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sanjay Vinaik; Phone Number: +91 0120-2777504; Email: drsanjayvinaik@gmail.com

Study Locations

• India
  • Uttar Pradesh
    • Ghaziabad, Uttar Pradesh, India
      • Recruiting
      • Navin Hospital
      • Contact: Dr Shruti Saini; Phone Number: +919911757070

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nuvastatic + standard treatment; 5 patients, dosage: 3000 mg of Nuvastatic™ (C5OSEW5050ESA) each day plus standard of care thrice daily (morning, afternoon and evening (one sachet each) to be taken for 14 days in Covid-19 patients.	Drug: Nuvastatic; Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy; Other Names: C5OSEW5050ESA
PLACEBO_COMPARATOR: Placebo; 5 patients, dosage: 3000 mg of placebo each day plus standard of care thrice daily (morning, afternoon and evening (one sachet each) to be taken for 14 days in Covid-19 patients.	Drug: Nuvastatic; Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy; Other Names: C5OSEW5050ESA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate safety and efficacy Nuvastatic™ (C5OSEW5050ESA)	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.	14 Days
IL-6 reduction	Improvement of Biomarkers: IL-6 reduction	14 Days
Serum c-reactive protein (CRP)	Improvement of Biomarkers:key inflammatory markers Serum c-reactive protein (CRP)	14 Days
IgG	Improvement of Biomarkers:key inflammatory markers IgG	14 Days
Hb	Improvement of Biomarkers:key inflammatory markers Hb	14 Days
Total leucocyte count	Improvement of Biomarkers:key inflammatory markers Total leucocyte count	14 Days
F2-Isoprostane	Improvement of Biomarkers:key inflammatory markers urinary F2-Isoprostane.	14 Days
Improvement in ARDS associated clinical symptoms cause	Role of VEGF as potential therapeutic target in acute respiratory distress syndrome (ARDS)	14 Days

Collaborators and Investigators

• Sponsor: Natureceuticals Sdn Bhd
• Investigators: Principal Investigator: Sanjay Vinaik, Navin Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: September 6, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BIAG-CSP-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Institutional sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No