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

NCT ID: NCT04596085

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2020-12-12

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Investigational product

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

Group Type: ACTIVE_COMPARATOR

Investigational Product - ViraCide

Intervention Type: DIETARY_SUPPLEMENT

Viracide

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo - Starch Powder Soft gels

Intervention Type: OTHER

Starch Powder Soft gels

Interventions

Investigational Product - ViraCide

Viracide

Intervention Type: DIETARY_SUPPLEMENT

Placebo - Starch Powder Soft gels

Starch Powder Soft gels

Intervention Type: OTHER

Other Intervention Names

Investigational Product; Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ProRelix Research

INDUSTRY

Sponsor Role: collaborator

The Herb, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Ninad Naik, MD(Ayurveda)

Role: PRINCIPAL_INVESTIGATOR

Gunjkar Multispeciality Hospital

Dr. A Gopal Rao, MD(Med)

Role: PRINCIPAL_INVESTIGATOR

Government medical college and Government general hospital

Locations

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

Srikakulam, Andhra Pradesh, India

Gunjkar Multispeciality Hospital

Pune, Maharashtra, India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NS-VC-CT01-20

Identifier Type: -

Identifier Source: org_study_id