A Double Blind, Randomized, Placebo Controlled Study to Evaluate Efficacy and Safety of "VIRACIDE" in the Management of Corona Virus Disease 2019 (COVID-19)
Phase: NA
Conditions: Covid19
Sponsor: The Herb, Inc

21 Aug 2020 
Confidential document 
Final Protocol 
 
 
 
 
 
 
 
CLINICAL STUDY PROTOCOL 
 
 
 
PROTOCOL 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) 
 
 
 
 
 
 
 
Protocol Number: NS-VC-CT01-20 
Clinicaltrial.gov ID: NCT04596085 
 
 
 
 
Protocol No:NS-VC-CT01-20 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
 
 
 
 
 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
 
STUDY SYNOPSIS 
 
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). 
Study Description 
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. 
Investigational 
Product/Study drug 
ViraCide softgels given per orally 
Comparison product 
Matching placebo of ViraCide softgels given per orally 
Study Design 
Double blind, randomized, placebo controlled study. Subjects 
will be randomized to the experimental and control groups in a 1: 
1 ratio. In each group 62 subjects will be recruited, a total of 124 
subjects. Subjects of the experimental arm will receive treatment 
with Study Drug, ViraCide and SOC. The control group will 
receive matching placebo and SOC. The study consists of the 
stages of screening, therapy, observation. There will be no 
switching of subjects between the arms. Participants will receive 
Study drug or matching placebo for 14 days during the study. 
Sample Size 
124, including 10% dropouts 
Study Population 
 
50 years or older 
 
Positive RT- PCR forSars-Co-V2. 
 
Either asymptomatic or have mild symptoms. Onset 
of symptoms within no more than 4days 
 
With chronic stable medical conditions: Diabetes Mellitus, 
or Hypertension, or chronic heart disease. 
Study Duration 
Total study duration approximately 35 days Screening: 04 days 
Treatment duration: 14 days 
Follow-up: 14 days from end of treatment 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
Number of Sites 
02 (two) 
Treatment Duration 
14 days 
Treatment Arms 
Two treatment arms 
 
Arm A: ViraCide softgels: 3 soft gels, two times every 
day after breakfast and dinner for 14 days+ SOC 
Therapy 
 
Arm B: Placebo softgels: 3 soft gels, two times 
everyday after breakfast and dinner for 14 days + SOC 
Therapy 
Purpose of the study 
To study the effectiveness and safety of the Study Drug, 
ViraCide 
softgels by oral administration compared with placebo softgels in 
50 years or older subjects with asymptomatic or mildly 
symptomatic coronovirus infection (COVID-19) and stable 
comorbidities. 
Objectives 
Primary Objectives 
1. To evaluate the efficacy of “ViraCide” in the management of 
mild COVID-19 disease 
Secondary Objectives 
1. To evaluate the safety of “ViraCide” in the management of 
mild COVID-19 disease 
Primary Endpoints 
1. TTCI using NEWS Score [Time Frame: 
First treatment date up to discharge day (PI’s 
discretion as per patients health condition)] 
The median time in days from the start of treatment with the 
study drug / placebo to the persistent achievement of all of the 
following criteria: 
 
 Stopping a fever (which is defined as a decrease in 
axillary temperature below 37 ° C without the use 
of anti pyretic drugs); 
 
Respiratory rate <22 /min; 
 
Oxygen saturation (SPO2) > 95% when breathing 
in atmospheric air. Measured using pulse oximetry 
 
Systolic blood pressure ≤200mmHg 
 
Pulse rate 51-90beats/minute 
 
Is conscious and alert 
[Note: Persistent achievement means the preservation of each of 
the criteria for at least 7days.] 
2. TTIC using 7-point ordinal scale 
3. Rate of progression to severe/critical COVID-19 disease 
based on NEWS score [Time frame: First treatment date 
up to 15days] 
4. Rate of progression to severe/critical COVID-19 disease 
based on 7-point ordinal scale [Time frame: First 
treatment date up to 28days] 
5. Time to COVID-19 nucleic acid testing negativity in 
oropharyngeal/nasal swab) [Time Frame: First 
treatment date up to 28days] 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
Secondary Endpoints 
1. Incidence of ICU admissions [Time Frame: 28days] 
2. Subject survival rate [Time Frame: 28days] 
3. Incidence of mechanical ventilation due to COVID-19 
infection [Time Frame: First treatment date up to 
28days] 
4. Change in clinical or laboratory assessment of comorbid 
condition [Time Frame: First treatment date up to 
28days] 
5. Percent of participants with worsening comorbid condition 
[Time Frame: First treatment date up to 28days] 
6. Proportion of subjects in the treatment arm who 
had AE, SAE 
7. Proportion of subjects in the placebo arm who had 
AE, SAE 
Subject Selection Criteria 
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). 
4. 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. 
5. Chronic stable medical conditions: diabetes mellitus, or 
hypertension, or chronic heart disease. Under treatment 
and controlled by medication 
6. Signed informed consent/or consent given through text 
message, WhatsApp ore-mail. 
7. Ability to understand the requirements of the Research 
Protocol and follow the research procedures. 
8. Subject should be willing to be managed in isolation 
wards 
9. Negative pregnancy test (for female participants) 
10. 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 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
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. 
Stopping the Study Drug 
1. Completing 14 days of treatment 
2. Progression to severe COVID-19: ViraCide will be 
stopped if subjects progresses to severe COVID-19 and 
require ICU admission, mechanical ventilation and any 
such situation where according to the PI the subject 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
cannot continue ViraCide. However, subject will be 
followed-up to capture data on ICU admission, incidence 
and mortality 
3. Progression of comorbid condition requiring admission 
to ICU or inability of the subject to take anything 
orally. However, subject will be followed-up to capture 
data on ICU admission, incidence and mortality 
4. Subject’s participation to the study is terminated 
5. Study is terminated 
Termination of Subject’s 
Participation in the Study 
Any participant can be removed from the study: 
1. By his/her own free will to not continue in the  
study. Subject withdrawal of informed consent. 
2. Loss of contact with the subject during the study. 
3. Does not comply with dosing schedule (75%-125% non- 
compliance) 
4. The development of AE / SAE requiring the withdrawal of 
the study drug. However all AE / SAE will be followed-up 
till the study duration 
5. Pregnancy confirmed anytime during the study duration 
6. Another reason, which, according to the PI, requires the 
termination of the subject's participation in the study. 
Study Termination 
The study can be terminated if 
1. There is a major deviation in Protocol 
2. Another reason, which, according to the PI, 
requires study termination 
Visits of Assessment 
Screening and 3 visits and one telephonic follow-up 
Screening 
Inclusion/Exclusion Criteria, Subject Inform Consent, 
Demography, Medical History, Physical Examination, Vital
Signs, HIV; HBsAg; HCV; Hs-CRP; Pulse oximetry; 
NEWS scoring; 7- point ordinal scoring; Medication list 
review (medications being taken for comorbid conditions), 
Lab assessment; Urine analysis Note: Patients who do not 
meet the study inclusion exclusion criteria during screening 
should not be randomized into the study. 
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 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
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. 
Laboratory Investigations 
Screening: Recording RT-PCR- Sars-Co-V2 result; Urine 
pregnancy test; HIV; HBsAg; HCV;Hs-CRP; Hematology* 
+ Biochemistry +Urine analysis*; ECG 
Day 1: No labs 
Day 7: No labs 
Day 15: Oropharyngeal/nasal swab for PCR- Sars-Co-V2; 
Hematology* + Biochemistry + Urine analysis*; ECG; 
Serological biomarker: Hs-CRP 
Note: 
*Hematology: Complete blood count (CBC); erythrocyte 
sedimentation rate (ESR) 
*Biochemistry: 
 
Random Blood Sugar, 
 
Serum Creatinine 
 
SGOT,SGPT 
 
Alkaline Phosphatase 
 
Bilirubin-Total/Direct/Indirect 
 
Total Proteins/Albumin/Globulin/A:Gratio 
 
Low density lipoprotein (LDL) Cholesterol(Direct) 
 
LDH 
 
Total Cholesterol 
 
Triglycerides 
 
High Sensitive C-reactive protein(HS-CRP) 
 
BUN (Blood Urea Nitrogen) /Urea 
 
Serum Calcium 
 
Serum Sodium 
 
Serum Potassium 
 
Uric Acid 
*X-ray PA view is an optional test at screening. It may be done 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol 
 
 
at any other time during the study if deemed necessary by 
the Investigator 
*Urine pregnancy test (for females only) at screening 
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. 
Standard of Care Therapy 
SOC therapy for coronavirus infection (COVID-19,SARS- 
CoV- 
2) has not been developed yet. Treatment will be given as per 
the discretion of the PI or as per the guidelines issued by 
the GOI. GOI guidelines can be accessed here: 
https://www.mohfw.gov.in/ 
Concomitant Medications 
Allowed by the Protocol 
1. Medications for Diabetes Mellitus 
2. Medications for hypertension 
3. Statins 
4. Blood thinners like aspirin at PI discretion 
5. Any medication deemed necessary by the PI to manage 
the AE/SAE 
6. Any other medication deemed necessary by the PI to 
manage a comorbid condition that is not likely to 
affect the treatment Protocol 
Prohibited Concomitant 
Medications 
Any other herbal medicine or dietary supplement 
Statistical Analysis 
Sample size of total 112(56 cases in each arm) completed cases 
needed to assess the study objective at 80% power and 5% 
level of significance. 
Considering 10 % dropout total 124 (62 cases in each arm) 
cases will be enrolled in this study. 

Protocol No:NS-VC-CT01-20 
21 August 2020 
Confidential document 
Final Protocol Document Version 05