N/A
N=118
Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04596085 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 — 44; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Product - ViraCide (Dietary_supplement); Placebo - Starch Powder Soft gels (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- The Herb, Inc
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 |
44; 29 | — |
| PRIMARY Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1 |
45; 28 | — |
| PRIMARY Time to a Negative COVID-19 Nucleic Acid Testing |
5.47; 6.97 | — |
| PRIMARY Rate of Progression on National Early Warning Score |
— | — |
| PRIMARY Rate of Progression on 7- Point Ordinal Scale |
— | — |
| SECONDARY ICU Admissions |
0; 0 | — |
| SECONDARY Subject Survival |
59; 59 | — |
| SECONDARY Incidence of Mechanical Ventilation |
0; 0 | — |
| SECONDARY Change in Clinical or Laboratory Assessment of Comorbid Condition |
0; 0 | — |
| SECONDARY Percent of Participants With Worsening Comorbid Condition |
0; 0 | — |
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.
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) ( 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.
Data sourced from ClinicalTrials.gov (NCT04596085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.