NCT04542447

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Natureceuticals Sdn Bhd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Nuvastatic	Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-09-09
• Last updated: 2020-09-10

Locations

1 site across 1 country: India