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

Covid19 Clinical Trial

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)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• Virus Diseases

• NCT number: NCT04596085
• Study type: Interventional
• Source: The Herb, Inc
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Completion date: December 12, 2020