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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
118
Viracide
Starch Powder Soft gels
Department of General medicine/ clinical research. Government medical college and Government general hospital
Srikakulam, Andhra Pradesh, India
Gunjkar Multispeciality Hospital
Pune, Maharashtra, India
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: First treatment date up to 28 days
ICU Admissions
Incidence of ICU admissions
Time frame: Time frame: 28 days
Subject Survival
Subject survival in the trial
Time frame: 28 days
Incidence of Mechanical Ventilation
Number of incidences of mechanical ventilation due to COVID-19 infection
Time frame: 28 days
Change in Clinical or Laboratory Assessment of Comorbid Condition
To evaluate any decline in health condition due to comorbidity
Time frame: 28 days
Percent of Participants With Worsening Comorbid Condition
Percent of participants with worsening comorbid condition.
Time frame: 28 days
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