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

NCT04596085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-08-12

Study results available
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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.

Conditions

  • Covid19

Interventions

DIETARY_SUPPLEMENT

Investigational Product - ViraCide

Viracide

OTHER

Placebo - Starch Powder Soft gels

Starch Powder Soft gels

Sponsors & Collaborators

  • ProRelix Research

    collaborator INDUSTRY

  • The Herb, Inc

    lead INDUSTRY

Principal Investigators

  • Dr.Ninad Naik, MD(Ayurveda) · Gunjkar Multispeciality Hospital

  • Dr. A Gopal Rao, MD(Med) · Government medical college and Government general hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2020-12-12
Completion
2020-12-12

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596085 on ClinicalTrials.gov