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) (
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.
Dietary Supplement: Investigational Product - ViraCide
Viracide
Other Name: Investigational Product
Other: Placebo - Starch Powder Soft gels
Starch Powder Soft gels
Other Name: Placebo
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
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.
Department of General medicine/ clinical research. Government medical college and Government general hospital
Srikakulam, Andhra Pradesh, India
Gunjkar Multispeciality Hospital
Pune, Maharashtra, India