Covid19NCT04596085
Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)
A study testing Investigational Product - ViraCide in people with Covid19, run by The Herb, Inc at 2 sites in India.
Trial summary
This is a double blind randomized placebo controlled study will be conducted on 124 subjects, 50 years and older with mild or asymptomatic COVID-19. If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Covid19
- What is being tested?
- Investigational Product - ViraCide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesIndia
- Study dates
- 16 Sep 2020to 12 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years or older
- Both male and female subjects will be included
- Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V2. Diagnosed not more than 2 days ago(diagnosis
- ≤2days).
- Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath.
- Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic heart disease. Under treatment and controlled by medication
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- Signed informed consent/or consent given through text message, WhatsApp ore-mail.
- Ability to understand the requirements of the Research Protocol and follow the research procedures.
- Subject should be willing to be managed in isolation wards
- Negative pregnancy test (for female participants)
- Adequate contraception for study duration
Who cannot join
- Less than 50years
- With severe COVID-19 symptoms requiring immediate hospitalization
- Investigator considers the subject unsuitable for ViraCide
- History of symptoms of more than 4days
- COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2
- History of cardiopulmonary resuscitation
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- Subjects having history of organ failure or conditions requiring ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation or any other condition that in the PI"s opinion makes the subject unfit to participate
- Respiratory failure, ARDS or need of mechanical ventilation
- History of acute exacerbation of comorbidity like heart failure, diabetic ketoacidosis, myocardial infection, major cardiac rhythm disorder or any other condition that in the PI"s opinion makes the subject unfit to participate
- History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure
- History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate.
- History of or currently under treatment for asthma [exception: patients with history of asthma, not on medications/inhalers/nebulizers for at least 6 months before study start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that can compromise SpO2 and RR.
- HIV, HBsAg, HCV positive
- Any condition causing immunodeficiency
- Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels
- History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it
- History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ)
- Hypersensitivity reaction to Study drug/placebo
- Any psychiatric issue for which the subject is currently undergoing treatment
- Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence
- Inability to understand the requirements of the Research Protocol and follow the research procedures.
- Pregnant or lactating;
- Not willing to use adequate contraception during study duration
- Participation in any other clinical study less than 3months before the start of the study.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Gunjkar Multispeciality Hospital
Pune, Maharashtra, 411019
Department of General medicine/ clinical research. Government medical college and Government general hospital
Srikakulam, Andhra Pradesh, 532001
About this study
Official title: A Double Blind, Randomized, Placebo Controlled Study to Evaluate Efficacy and Safety of "VIRACIDE" in the Management of Corona Virus Disease 2019 (COVID-19)
This is a double blind randomized placebo controlled study will be conducted on 124 subjects, 50 years and older with mild or asymptomatic COVID-19. If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath.
The study will be conducted at two centers. There will be a screening visit at Day -4 followed by three visits at the center at Days 1, 7 and 15 and a follow-up visit on Day 28. All participants will be randomized to receive either ViraCide (investigational product) or matching placebo. All subjects will receive SOC therapy.
Note: If subject is discharged before Day 15 PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
Read the detailed description
Day 1 Randomization, Vital Signs, Pulse oximetry, AE/SAE, Concomitant Medication, ViraCide/ Placebo treatment start, NEWS scoring; 7-point ordinal scoring Day 7 Physical Examination, Vital Signs, AE/SAE, Concomitant Medication, ViraCide/ Placebo Compliance check, Pulse oximetry; NEWS scoring; 7-point ordinal scoring.
(Note: If the subject is discharged on this day as per PI's discretion and patient's health condition then assessment scheduled for day 15 will be carried out on discharge day).
Day 15 Physical Examination, Vital Signs, AE/SAE, Concomitant Medication, ViraCide/ Placebo treatment end, RT-PCR for Sars- Co-V2, Hs-CRP, Safety Lab Tests, Pulse oximetry; NEWS scoring; 7-point ordinal scoring, ViraCide/ Placebo Compliance check, Lab assessment including urine analysis Day 28
Phone call follow up for time :
- until negative RT-PCR for Sars-Co- V2, COVID-19 related mortality,
- development of any COVID-19 symptom,
- development of any worsening of comorbid condition;
- Development of new AE/SAE; Resolution status of previous AE/SAEs
Note: If subject is discharged before Day 15on PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
- Conditions
- Covid19
- Being tested
- Investigational Product - ViraCide, Placebo - Starch Powder Soft gels
- Keywords
- Coronavirus, (SARS-CoV-2)
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product - ViraCideDietary supplement
Also called Investigational Product
Viracide
Placebo - Starch Powder Soft gelsOther
Also called Placebo
Starch Powder Soft gels
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Active comparator | Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels . Fequency: 3 soft gels, two times every day after breakfast and dinner . Duration: 14 days+ SOC Therapy Receives: Dietary Supplement: Investigational Product - ViraCide |
| Placebo | Placebo comparator | Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy Receives: Other: Placebo - Starch Powder Soft gels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0
The proportion of cases with National Early Warning Score reduction from 3 to 0 till discharge day between two groups.
This score is associated with clinical risk and a decrease in score indicates a decrease in the risk to the patient and improvement in clinical condition.
Measured: First treatment date up to discharge day, an average of 1 week
Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1
Proportion of cases with 7-point ordinal scale score reduction from 3 to 1 till day 7.
This score is associated with clinical improvement and a decrease in score indicates improvement in patient's clinical condition.
Measured: First treatment date up to day 7, i.e. up to 1 week
Time to a Negative COVID-19 Nucleic Acid Testing
Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Measured: Time Frame: First treatment date up to 28 days
Rate of Progression on National Early Warning Score
Rate of progression to the severe/critical COVID-19 disease
Measured: First treatment date up tp 28 days (28 days)
Rate of Progression on 7- Point Ordinal Scale
Rate of progression to the severe/critical COVID-19 disease
Measured: First treatment date up to 28 days
Secondary outcomes (5)
ICU Admissions
Incidence of ICU admissions
Measured: Time frame: 28 days
Subject Survival
Subject survival in the trial
Measured: 28 days
Incidence of Mechanical Ventilation
Number of incidences of mechanical ventilation due to COVID-19 infection
Measured: 28 days
Change in Clinical or Laboratory Assessment of Comorbid Condition
To evaluate any decline in health condition due to comorbidity
Measured: 28 days
Percent of Participants With Worsening Comorbid Condition
Percent of participants with worsening comorbid condition.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Sep 2020
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind, Randomized, Placebo Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Herb, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProRelix Research
- Responsible party
- Sponsor
- Investigators
- Dr.Ninad Naik, MD(Ayurveda), Principal investigator, Gunjkar Multispeciality HospitalDr. A Gopal Rao, MD(Med), Principal investigator, Government medical college and Government general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596085
- Sponsor's protocol ID
- NS-VC-CT01-20
- Status last verified
- Aug 2021
- First submitted
- 19 Oct 2020
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled Study to Evaluate Efficacy and Safety of "VIRACIDE" in the Management of Corona Virus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04596085
- Acronym / sponsor ID
- NS-VC-CT01-20
- Conditions
- Covid19
- Keywords
- Coronavirus, (SARS-CoV-2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- The Herb, IncIndustry (pharma, biotech, devices)
- Collaborators
- ProRelix Research
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind randomized placebo controlled study will be conducted on 124 subjects, 50 years and older with mild or asymptomatic COVID-19. If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath.
The study will be conducted at two centers. There will be a screening visit at Day -4 followed by three visits at the center at Days 1, 7 and 15 and a follow-up visit on Day 28. All participants will be randomized to receive either ViraCide (investigational product) or matching placebo. All subjects will receive SOC therapy.
Note: If subject is discharged before Day 15 PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
Detailed description
Day 1 Randomization, Vital Signs, Pulse oximetry, AE/SAE, Concomitant Medication, ViraCide/ Placebo treatment start, NEWS scoring; 7-point ordinal scoring Day 7 Physical Examination, Vital Signs, AE/SAE, Concomitant Medication, ViraCide/ Placebo Compliance check, Pulse oximetry; NEWS scoring; 7-point ordinal scoring.
(Note: If the subject is discharged on this day as per PI's discretion and patient's health condition then assessment scheduled for day 15 will be carried out on discharge day).
Day 15 Physical Examination, Vital Signs, AE/SAE, Concomitant Medication, ViraCide/ Placebo treatment end, RT-PCR for Sars- Co-V2, Hs-CRP, Safety Lab Tests, Pulse oximetry; NEWS scoring; 7-point ordinal scoring, ViraCide/ Placebo Compliance check, Lab assessment including urine analysis Day 28
Phone call follow up for time :
- until negative RT-PCR for Sars-Co- V2, COVID-19 related mortality,
- development of any COVID-19 symptom,
- development of any worsening of comorbid condition;
- Development of new AE/SAE; Resolution status of previous AE/SAEs
Note: If subject is discharged before Day 15on PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double Blind, Randomized, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Active comparator | Dietary Supplement: Investigational Product - ViraCideExperimental, Investigational Product Ingredient : ViraCide Dosage form softgels . Fequency: 3 soft gels, two times every day after breakfast and dinner . Duration: 14 days+ SOC Therapy |
| Placebo | Placebo comparator | Other: Placebo - Starch Powder Soft gelsIngredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 50 years or older
- Both male and female subjects will be included
- Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V2. Diagnosed not more than 2 days ago(diagnosis
- ≤2days).
- Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath.
Key exclusion criteria (24 listed)
- Less than 50years
- With severe COVID-19 symptoms requiring immediate hospitalization
- Investigator considers the subject unsuitable for ViraCide
- History of symptoms of more than 4days
- COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2
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 |
|---|---|---|
| Investigational Product - ViraCideAlso: Investigational ProductViracide | Dietary supplement | Investigational product |
| Placebo - Starch Powder Soft gelsAlso: PlaceboStarch Powder Soft gels | Other | Placebo |
Primary outcome
Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0
Time frame: First treatment date up to discharge day, an average of 1 week
The proportion of cases with National Early Warning Score reduction from 3 to 0 till discharge day between two groups. This score is associated with clinical risk and a decrease in score indicates a decrease in the risk to the patient and improvement in clinical condition.
Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1
Time frame: First treatment date up to day 7, i.e. up to 1 week
Proportion of cases with 7-point ordinal scale score reduction from 3 to 1 till day 7. This score is associated with clinical improvement and a decrease in score indicates improvement in patient's clinical condition.
Time to a Negative COVID-19 Nucleic Acid Testing
Time frame: Time Frame: First treatment date up to 28 days
Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Rate of Progression on National Early Warning Score
Time frame: First treatment date up tp 28 days (28 days)
Rate of progression to the severe/critical COVID-19 disease
Rate of Progression on 7- Point Ordinal Scale
Time frame: First treatment date up to 28 days
Rate of progression to the severe/critical COVID-19 disease
5 secondary outcomes
ICU Admissions
Time frame: Time frame: 28 days
Subject Survival
Time frame: 28 days
Incidence of Mechanical Ventilation
Time frame: 28 days
Change in Clinical or Laboratory Assessment of Comorbid Condition
Time frame: 28 days
Percent of Participants With Worsening Comorbid Condition
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dr.Ninad Naik, MD(Ayurveda) principal investigator
Gunjkar Multispeciality Hospital
Dr. A Gopal Rao, MD(Med) principal investigator
Government medical college and Government general hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Product - ViraCide in people with Covid19, run by The Herb, Inc at 2 sites 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 11 inclusion and 24 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: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 (time frame: First treatment date up to discharge day, an average of 1 week). The study lists 5 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 12 Aug 2021.