search
Back to results

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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Investigational Product - ViraCide
Placebo - Starch Powder Soft gels
Sponsored by
The Herb, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring Coronavirus, (SARS-CoV-2)

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 50 years or older
  2. Both male and female subjects will be included
  3. Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V2. Diagnosed not more than 2 days ago(diagnosis

    ≤2days).

  4. 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.
  5. Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic heart disease. Under treatment and controlled by medication
  6. Signed informed consent/or consent given through text message, WhatsApp ore-mail.
  7. Ability to understand the requirements of the Research Protocol and follow the research procedures.
  8. Subject should be willing to be managed in isolation wards
  9. Negative pregnancy test (for female participants)
  10. Adequate contraception for study duration

Exclusion Criteria:

  1. Less than 50years
  2. With severe COVID-19 symptoms requiring immediate hospitalization
  3. Investigator considers the subject unsuitable for ViraCide
  4. History of symptoms of more than 4days
  5. COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2
  6. History of cardiopulmonary resuscitation
  7. 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
  8. Respiratory failure, ARDS or need of mechanical ventilation
  9. 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
  10. History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure
  11. History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate.
  12. 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.
  13. HIV, HBsAg, HCV positive
  14. Any condition causing immunodeficiency
  15. Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels
  16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it
  17. History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ)
  18. Hypersensitivity reaction to Study drug/placebo
  19. Any psychiatric issue for which the subject is currently undergoing treatment
  20. Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence
  21. Inability to understand the requirements of the Research Protocol and follow the research procedures.
  22. Pregnant or lactating;
  23. Not willing to use adequate contraception during study duration
  24. Participation in any other clinical study less than 3months before the start of the study.

Sites / Locations

  • Department of General medicine/ clinical research. Government medical college and Government general hospital
  • Gunjkar Multispeciality Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Investigational product

Placebo

Arm Description

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

Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy

Outcomes

Primary Outcome Measures

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.
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.
Time to a Negative COVID-19 Nucleic Acid Testing
Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Rate of Progression on National Early Warning Score
Rate of progression to the severe/critical COVID-19 disease
Rate of Progression on 7- Point Ordinal Scale
Rate of progression to the severe/critical COVID-19 disease

Secondary Outcome Measures

ICU Admissions
Incidence of ICU admissions
Subject Survival
Subject survival in the trial
Incidence of Mechanical Ventilation
Number of incidences of mechanical ventilation due to COVID-19 infection
Change in Clinical or Laboratory Assessment of Comorbid Condition
To evaluate any decline in health condition due to comorbidity
Percent of Participants With Worsening Comorbid Condition
Percent of participants with worsening comorbid condition.

Full Information

First Posted
October 19, 2020
Last Updated
August 11, 2021
Sponsor
The Herb, Inc
Collaborators
ProRelix Services LLP
search

1. Study Identification

Unique Protocol Identification Number
NCT04596085
Brief Title
Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
December 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Herb, Inc
Collaborators
ProRelix Services LLP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Coronavirus, (SARS-CoV-2)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double Blind, Randomized, Placebo Controlled
Masking
ParticipantInvestigator
Masking Description
Randomized, Double - Blind
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational product
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Investigational Product - ViraCide
Other Intervention Name(s)
Investigational Product
Intervention Description
Viracide
Intervention Type
Other
Intervention Name(s)
Placebo - Starch Powder Soft gels
Other Intervention Name(s)
Placebo
Intervention Description
Starch Powder Soft gels
Primary Outcome Measure Information:
Title
Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0
Description
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.
Time Frame
First treatment date up to discharge day, an average of 1 week
Title
Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1
Description
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.
Time Frame
First treatment date up to day 7, i.e. up to 1 week
Title
Time to a Negative COVID-19 Nucleic Acid Testing
Description
Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Time Frame
Time Frame: First treatment date up to 28 days
Title
Rate of Progression on National Early Warning Score
Description
Rate of progression to the severe/critical COVID-19 disease
Time Frame
First treatment date up tp 28 days (28 days)
Title
Rate of Progression on 7- Point Ordinal Scale
Description
Rate of progression to the severe/critical COVID-19 disease
Time Frame
First treatment date up to 28 days
Secondary Outcome Measure Information:
Title
ICU Admissions
Description
Incidence of ICU admissions
Time Frame
Time frame: 28 days
Title
Subject Survival
Description
Subject survival in the trial
Time Frame
28 days
Title
Incidence of Mechanical Ventilation
Description
Number of incidences of mechanical ventilation due to COVID-19 infection
Time Frame
28 days
Title
Change in Clinical or Laboratory Assessment of Comorbid Condition
Description
To evaluate any decline in health condition due to comorbidity
Time Frame
28 days
Title
Percent of Participants With Worsening Comorbid Condition
Description
Percent of participants with worsening comorbid condition.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 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 Exclusion Criteria: 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 History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ) Hypersensitivity reaction to Study drug/placebo Any psychiatric issue for which the subject is currently undergoing treatment Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence Inability to understand the requirements of the Research Protocol and follow the research procedures. Pregnant or lactating; Not willing to use adequate contraception during study duration Participation in any other clinical study less than 3months before the start of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Ninad Naik, MD(Ayurveda)
Organizational Affiliation
Gunjkar Multispeciality Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. A Gopal Rao, MD(Med)
Organizational Affiliation
Government medical college and Government general hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General medicine/ clinical research. Government medical college and Government general hospital
City
Srikakulam
State/Province
Andhra Pradesh
ZIP/Postal Code
532001
Country
India
Facility Name
Gunjkar Multispeciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411019
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs