Clinical trial NCT04542447: To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Natureceuticals Sdn Bhd
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Immunomodulator in COVID 19, Intervention - Sequentially numbered IP kits
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate safety and efficacy Nuvastatic™ (C5OSEW5050ESA)
timeFrame: 14 Days
measure: IL-6 reduction
timeFrame: 14 Days
measure: Serum c-reactive protein (CRP)
timeFrame: 14 Days
measure: IgG
timeFrame: 14 Days
measure: Hb
timeFrame: 14 Days
measure: Total leucocyte count
timeFrame: 14 Days
measure: F2-Isoprostane
timeFrame: 14 Days
measure: Improvement in ARDS associated clinical symptoms cause
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Ghaziabad
country: India
facility: Navin Hospital
state: Uttar Pradesh
Study officials:
affiliation: Navin Hospital
name: Sanjay Vinaik
role: PRINCIPAL_INVESTIGATOR
References: