Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)
Condition: Covid19
MeSH terms: COVID-19; Virus Diseases; Coronavirus Infections
Study type: Interventional

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.
    

Intervention name(s): Investigational Product - ViraCide; Placebo - Starch Powder Soft gels
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Viracide; Starch Powder Soft gels
Other intervention name(s): Investigational Product; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind, Randomized, Placebo Controlled
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Coronavirus, (SARS-CoV-2)