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

NCT04542447 | Unknown Phase 1 DMC

• 1 other identifier: BIAG-CSP-037
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.The duration of mechanical ventilation.
2. 2.The duration of hospitalization in survivors.
3. 3.The time (in days) from treatment initiation to death.
4. 4.Virologic measures included the proportions with viral RNA detection over time and viral RNA titer area under-curve (auc) measurements.

Conditions

Covid19

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Nuvastatic + standard treatment

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Nuvastatic DRUG

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

Also known as: C5OSEW5050ESA

Nuvastatic + standard treatment; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and nonpregnant female patients 18 years of age or older eligible if they had a diagnostic specimen that was positive on RT-PCR. -
• For Mild - Moderate cases: Subjects who show positive for nasal swab test at screening using RT-PCR protocol for Covid 19.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Female subjects who are pregnant or breastfeeding.
• Patients who are allergic to this medicine
• Patients allergic to content of study product
• Patients with diabetes.
• Patients accompanied by serious physical diseases of heart, lung, brain, etc.
• Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
• Patients who are not able to take drugs orally.

Sponsors & Collaborators

• Natureceuticals Sdn Bhd: lead

Study Sites (1)

Navin Hospital

Ghaziabad, Uttar Pradesh, India

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sanjay Vinaik

  Navin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Vinaik

CONTACT

+91 0120-2777504; drsanjayvinaik@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: An open label proof of concept study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Immunomodulator in COVID 19, Intervention - Sequentially numbered IP kits

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 9, 2020
• Study Start: September 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)