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

Study Overview
=================
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.

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.

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)

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Dietary Supplement: Investigational Product - ViraCide
* Other: Placebo - Starch Powder Soft gels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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 PIs 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 PIs 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blind, Randomized, Placebo Controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational product<br>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<br>* Viracide<br>* Other names: Investigational Product;|
| Placebo Comparator: Placebo<br>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<br>* Starch Powder Soft gels<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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: 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 | 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 | First treatment date up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Admissions | Incidence of ICU admissions | Time frame: 28 days | 
| Subject Survival | Subject survival in the trial | 28 days | 
| Incidence of Mechanical Ventilation | Number of incidences of mechanical ventilation due to COVID-19 infection | 28 days | 
| Change in Clinical or Laboratory Assessment of Comorbid Condition | To evaluate any decline in health condition due to comorbidity | 28 days | 
| Percent of Participants With Worsening Comorbid Condition | Percent of participants with worsening comorbid condition. | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus, (SARS-CoV-2)