Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)

• Sponsor: The Herb, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04596085
• Collaborator: ProRelix Services LLP (Other)
• Enrollment: 118
• Locations: 2
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site: 59
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Dietary Supplement: Investigational Product - ViraCide; Other: Placebo - Starch Powder Soft gels	N/A

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

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double Blind, Randomized, Placebo ControlledDouble Blind, Randomized, Placebo Controlled
• Masking: Double (Participant, Investigator)
• Masking Description: Randomized, Double - Blind
• Primary Purpose: Supportive Care
• 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)
• Actual Study Start Date: Sep 16, 2020
• Actual Primary Completion Date: Dec 12, 2020
• Actual Study Completion Date: Dec 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Investigational product 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	Dietary Supplement: Investigational Product - ViraCide; Viracide; Other Names: Investigational Product
Placebo Comparator: Placebo Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy	Other: Placebo - Starch Powder Soft gels; Starch Powder Soft gels; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 [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.

2. Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1 [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.

3. Time to a Negative COVID-19 Nucleic Acid Testing [Time Frame: First treatment date up to 28 days]

   Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)

4. Rate of Progression on National Early Warning Score [First treatment date up tp 28 days (28 days)]

   Rate of progression to the severe/critical COVID-19 disease

5. Rate of Progression on 7- Point Ordinal Scale [First treatment date up to 28 days]

   Rate of progression to the severe/critical COVID-19 disease

Secondary Outcome Measures

1. ICU Admissions [Time frame: 28 days]

   Incidence of ICU admissions

2. Subject Survival [28 days]

   Subject survival in the trial

3. Incidence of Mechanical Ventilation [28 days]

   Number of incidences of mechanical ventilation due to COVID-19 infection

4. Change in Clinical or Laboratory Assessment of Comorbid Condition [28 days]

   To evaluate any decline in health condition due to comorbidity

5. Percent of Participants With Worsening Comorbid Condition [28 days]

   Percent of participants with worsening comorbid condition.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 50 years or older

2. Both male and female subjects will be included

3. Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V2. Diagnosed not more than 2 days ago(diagnosis

≤2days).

1. 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.

2. Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic heart disease. Under treatment and controlled by medication

3. Signed informed consent/or consent given through text message, WhatsApp ore-mail.

4. Ability to understand the requirements of the Research Protocol and follow the research procedures.

5. Subject should be willing to be managed in isolation wards

6. Negative pregnancy test (for female participants)

7. Adequate contraception for study duration

Exclusion Criteria:

1. Less than 50years

2. With severe COVID-19 symptoms requiring immediate hospitalization

3. Investigator considers the subject unsuitable for ViraCide

4. History of symptoms of more than 4days

5. COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2

6. History of cardiopulmonary resuscitation

7. 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

8. Respiratory failure, ARDS or need of mechanical ventilation

9. 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

10. History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure

11. History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate.

12. 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.

13. HIV, HBsAg, HCV positive

14. Any condition causing immunodeficiency

15. Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels

16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it

17. History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ)

18. Hypersensitivity reaction to Study drug/placebo

19. Any psychiatric issue for which the subject is currently undergoing treatment

20. Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence

21. Inability to understand the requirements of the Research Protocol and follow the research procedures.

22. Pregnant or lactating;

23. Not willing to use adequate contraception during study duration

24. Participation in any other clinical study less than 3months before the start of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General medicine/ clinical research. Government medical college and Government general hospital	Srikakulam	Andhra Pradesh	India	532001
2	Gunjkar Multispeciality Hospital	Pune	Maharashtra	India	411019

Sponsors and Collaborators

• The Herb, Inc
• ProRelix Services LLP

Investigators

• Principal Investigator: Dr.Ninad Naik, MD(Ayurveda), Gunjkar Multispeciality Hospital
• Principal Investigator: Dr. A Gopal Rao, MD(Med), Government medical college and Government general hospital

Study Documents (Full-Text)

• Study Protocol - Aug 21, 2020
• Statistical Analysis Plan - Jun 4, 2020

More Information

Publications

None provided.

• Responsible Party: The Herb, Inc
• ClinicalTrials.gov Identifier: NCT04596085
• Other Study ID Numbers: NS-VC-CT01-20
• First Posted: Oct 22, 2020
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Herb, Inc: Coronavirus, (SARS-CoV-2)
• Additional relevant MeSH terms: COVID-19; Virus Diseases; Coronavirus Infections

Study Results

Participant Flow

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	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 Investigational Product - ViraCide: Viracide	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy Placebo - Starch Powder Soft gels: Starch Powder Soft gels
Period Title: Overall Study
STARTED	59	59
COMPLETED	59	59
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Investigational Product	Placebo	Total
Arm/Group Description	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 Investigational Product - ViraCide: Viracide	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy Placebo - Starch Powder Soft gels: Starch Powder Soft gels	Total of all reporting groups
Overall Participants	59	59	118
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.53 (5.81)	60.44 (7.01)	59.48 (6.41)
Sex: Female, Male (Count of Participants)
Female	21 35.6%	23 39%	44 37.3%
Male	38 64.4%	36 61%	74 62.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	59 100%	59 100%	118 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0
Description	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.
Time Frame	First treatment date up to discharge day, an average of 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Ingredient, Placebo Ingredient Starch softgels.
Measure Participants	59	59
Count of Participants [Participants]	44 74.6%	29 49.2%

2. Primary Outcome

Title	Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1
Description	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 Frame	First treatment date up to day 7, i.e. up to 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Ingredient, Placebo Ingredient Starch softgels.
Measure Participants	59	59
Count of Participants [Participants]	45 76.3%	28 47.5%

3. Primary Outcome

Title	Time to a Negative COVID-19 Nucleic Acid Testing
Description	Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Time Frame	Time Frame: First treatment date up to 28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Ingredient, Placebo Ingredient Starch softgels.
Measure Participants	59	59
Mean (Standard Deviation) [days]	5.47 (0.49)	6.97 (0.61)

4. Primary Outcome

Title	Rate of Progression on National Early Warning Score
Description	Rate of progression to the severe/critical COVID-19 disease
Time Frame	First treatment date up tp 28 days (28 days)

Outcome Measure Data

Analysis Population Description

The Rate of progression to the severity of the disease was not identifiable as most of the subjects were discharged on Day 7 or 8

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	0	0

5. Primary Outcome

Title	Rate of Progression on 7- Point Ordinal Scale
Description	Rate of progression to the severe/critical COVID-19 disease
Time Frame	First treatment date up to 28 days

Outcome Measure Data

Analysis Population Description

The Rate of progression to the severity of the disease was not identifiable as most of the subjects were discharged on Day 7 or 8

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	0	0

6. Secondary Outcome

Title	ICU Admissions
Description	Incidence of ICU admissions
Time Frame	Time frame: 28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	59	59
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Subject Survival
Description	Subject survival in the trial
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	59	59
Count of Participants [Participants]	59 100%	59 100%

8. Secondary Outcome

Title	Incidence of Mechanical Ventilation
Description	Number of incidences of mechanical ventilation due to COVID-19 infection
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	59	59
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

Title	Change in Clinical or Laboratory Assessment of Comorbid Condition
Description	To evaluate any decline in health condition due to comorbidity
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	59	59
Count of Participants [Participants]	0 0%	0 0%

10. Secondary Outcome

Title	Percent of Participants With Worsening Comorbid Condition
Description	Percent of participants with worsening comorbid condition.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Product	Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.	Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
Measure Participants	59	59
Mean (Standard Deviation) [percentage]	0 (0)	0 (0)

Adverse Events

Time Frame	28 days
Arm/Group Title	Investigational Product		Placebo
Arm/Group Description	Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .		Ingredient, Placebo Ingredient Starch softgels.
All Cause Mortality
	Investigational Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)
Serious Adverse Events
	Investigational Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Investigational Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/59 (5.1%)		4/59 (6.8%)
Ear and labyrinth disorders
vertigo	1/59 (1.7%)	1	0/59 (0%)	0
General disorders
nausea	1/59 (1.7%)	1	2/59 (3.4%)	2
mouth ulcer	1/59 (1.7%)	1	2/59 (3.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Confidential information during the course of the study and clinical development plan, except the information already existing in the public domain, and all results and reports obtained, collected, conceived, processed and developed pursuant to this Agreement, The INSTITUTION shall use confidential information for the sole purpose of providing services under this Agreement and shall not use confidential information for the INSTITUTION's own benefit at any time.