A Double Blind, Randomized, Placebo Controlled Study to Evaluate Efficacy and Safety of "VIRACIDE" in the Management of Corona Virus Disease 2019 (COVID-19)

Detailed 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.

Study Details

Timeline

Interventions