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

NCT04596085 | Completed Results

• 1 other identifier: NS-VC-CT01-20
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

Coronavirus, (SARS-CoV-2)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• ICU Admissions

  Time frame: 28 days

• Subject Survival

  28 days

• Incidence of Mechanical Ventilation

  28 days

• Change in Clinical or Laboratory Assessment of Comorbid Condition

  28 days

• Percent of Participants With Worsening Comorbid Condition

  28 days

Study Arms (2)

Investigational product

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Investigational Product - ViraCide DIETARY_SUPPLEMENT

Viracide

Also known as: Investigational Product

Investigational product

Placebo - Starch Powder Soft gels OTHER

Starch Powder Soft gels

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 PI"s 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 PI"s 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

Sponsors & Collaborators

• The Herb, Inc: lead
• ProRelix Research: collaborator

Study Sites (2)

Department of General medicine/ clinical research. Government medical college and Government general hospital

Srikakulam, Andhra Pradesh, 532001, India

Location

Gunjkar Multispeciality Hospital

Pune, Maharashtra, 411019, India

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Mahir Abduldaim
• Organization: Natural Supplements LLC

maherdaim@yahoo.com

+966557880299

Study Officials

• Dr.Ninad Naik, MD(Ayurveda)

  Gunjkar Multispeciality Hospital

  PRINCIPAL INVESTIGATOR

• Dr. A Gopal Rao, MD(Med)

  Government medical college and Government general hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, Double - Blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Blind, Randomized, Placebo Controlled

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 22, 2020
• Study Start: September 16, 2020
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: August 12, 2021
• Results First Posted: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)