Covid19Phase 1NCT04542447
To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients.
A Phase 1 study testing Nuvastatic in people with Covid19, run by Natureceuticals Sdn Bhd at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Nuvastatic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2020to 30 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Navin Hospital
Ghaziabad, Uttar Pradesh
Dr Shruti Saini, +919911757070
About this study
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.
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.
Read more
Secondary Outcome Measures: Clinical status as assessed with the seven-category ordinal scale on days 7 and 14, mortality at day 28.
- The duration of mechanical ventilation.
- The duration of hospitalization in survivors.
- The time (in days) from treatment initiation to death.
- Virologic measures included the proportions with viral RNA detection over time and viral RNA titer area under-curve (auc) measurements.
Read the 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
- Being tested
- Nuvastatic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvastaticDrug
Also called C5OSEW5050ESA
Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nuvastatic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 Days
IL-6 reduction
Improvement of Biomarkers: IL-6 reduction
Measured: 14 Days
Serum c-reactive protein (CRP)
Improvement of Biomarkers:key inflammatory markers Serum c-reactive protein (CRP)
Measured: 14 Days
IgG
Improvement of Biomarkers:key inflammatory markers IgG
Measured: 14 Days
Hb
Improvement of Biomarkers:key inflammatory markers Hb
Measured: 14 Days
Total leucocyte count
Improvement of Biomarkers:key inflammatory markers Total leucocyte count
Measured: 14 Days
F2-Isoprostane
Improvement of Biomarkers:key inflammatory markers urinary F2-Isoprostane.
Measured: 14 Days
Improvement in ARDS associated clinical symptoms cause
Role of VEGF as potential therapeutic target in acute respiratory distress syndrome (ARDS)
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Sep 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Immunomodulator in COVID 19, Intervention - Sequentially numbered IP kits
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natureceuticals Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Vinaik, Principal investigator, Navin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542447
- Sponsor's protocol ID
- BIAG-CSP-037
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Institutional sharing
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04542447
- Acronym / sponsor ID
- BIAG-CSP-037
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Natureceuticals Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The duration of mechanical ventilation.
- The duration of hospitalization in survivors.
- The time (in days) from treatment initiation to death.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Immunomodulator in COVID 19, Intervention - Sequentially numbered IP kits
| Arm | Type | Receives |
|---|---|---|
| Nuvastatic + standard treatment | Active comparator | Drug: Nuvastatic5 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. |
| Placebo | Placebo comparator | Drug: Nuvastatic5 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuvastaticAlso: C5OSEW5050ESAPolymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy | Drug | Nuvastatic + standard treatment, Placebo |
Primary outcome
To evaluate safety and efficacy Nuvastatic™ (C5OSEW5050ESA)
Time frame: 14 Days
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.
IL-6 reduction
Time frame: 14 Days
Improvement of Biomarkers: IL-6 reduction
Serum c-reactive protein (CRP)
Time frame: 14 Days
Improvement of Biomarkers:key inflammatory markers Serum c-reactive protein (CRP)
IgG
Time frame: 14 Days
Improvement of Biomarkers:key inflammatory markers IgG
Hb
Time frame: 14 Days
Improvement of Biomarkers:key inflammatory markers Hb
Total leucocyte count
Time frame: 14 Days
Improvement of Biomarkers:key inflammatory markers Total leucocyte count
F2-Isoprostane
Time frame: 14 Days
Improvement of Biomarkers:key inflammatory markers urinary F2-Isoprostane.
Improvement in ARDS associated clinical symptoms cause
Time frame: 14 Days
Role of VEGF as potential therapeutic target in acute respiratory distress syndrome (ARDS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No. Institutional sharing
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Vinaik principal investigator
Navin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nuvastatic in people with Covid19, run by Natureceuticals Sdn Bhd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Vinaik (+91 0120-2777504, drsanjayvinaik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety and efficacy Nuvastatic™ (C5OSEW5050ESA) (time frame: 14 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.