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

NCT ID: NCT04542447

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2020-09-30

Brief 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.

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nuvastatic

Intervention Type: DRUG

Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy

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.

Group Type: PLACEBO_COMPARATOR

Nuvastatic

Intervention Type: DRUG

Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy

Interventions

Nuvastatic

Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy

Intervention Type: DRUG

Other Intervention Names

C5OSEW5050ESA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Natureceuticals Sdn Bhd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Vinaik

Role: PRINCIPAL_INVESTIGATOR

Navin Hospital

Locations

Navin Hospital

Ghaziabad, Uttar Pradesh, India

Site Status: RECRUITING

Countries

India

Central Contacts

Sanjay Vinaik

Role: CONTACT

drsanjayvinaik@gmail.com

+91 0120-2777504

Facility Contacts

Dr Shruti Saini

Role: primary

+919911757070

Other Identifiers

BIAG-CSP-037

Identifier Type: -

Identifier Source: org_study_id