Covid19
Conditions
Keywords
Coronavirus, (SARS-CoV-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.
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.
Interventions
DIETARY_SUPPLEMENTInvestigational Product - ViraCide
Viracide
OTHERPlacebo - Starch Powder Soft gels
Starch Powder Soft gels
Sponsors
ProRelix Research
The Herb, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomized, Double - Blind
Intervention model description
Double Blind, Randomized, Placebo Controlled
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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 PIs 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 PIs 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 | First treatment date up to discharge day, an average of 1 week | 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 | First treatment date up to day 7, i.e. up to 1 week | 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 Frame: First treatment date up to 28 days | Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab) |
| Rate of Progression on National Early Warning Score | First treatment date up tp 28 days (28 days) | Rate of progression to the severe/critical COVID-19 disease |
| Rate of Progression on 7- Point Ordinal Scale | First treatment date up to 28 days | Rate of progression to the severe/critical COVID-19 disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Admissions | Time frame: 28 days | Incidence of ICU admissions |
| Subject Survival | 28 days | Subject survival in the trial |
| Incidence of Mechanical Ventilation | 28 days | Number of incidences of mechanical ventilation due to COVID-19 infection |
| Change in Clinical or Laboratory Assessment of Comorbid Condition | 28 days | To evaluate any decline in health condition due to comorbidity |
| Percent of Participants With Worsening Comorbid Condition | 28 days | Percent of participants with worsening comorbid condition. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Investigational Product - ViraCide: Viracide | 59 |
| Placebo Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy
Placebo - Starch Powder Soft gels: Starch Powder Soft gels | 59 |
| Total | 118 |
Baseline characteristics
| Characteristic | Placebo | Total | Investigational Product |
|---|---|---|---|
| Age, Continuous | 60.44 years STANDARD_DEVIATION 7.01 | 59.48 years STANDARD_DEVIATION 6.41 | 58.53 years STANDARD_DEVIATION 5.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 59 Participants | 118 Participants | 59 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 44 Participants | 21 Participants |
| Sex: Female, Male Male | 36 Participants | 74 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 3 / 59 | 4 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
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 frame: First treatment date up to day 7, i.e. up to 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1 | 45 Participants |
| Placebo | Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1 | 28 Participants |
Primary
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.
Time frame: First treatment date up to discharge day, an average of 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 | 44 Participants |
| Placebo | Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0 | 29 Participants |
Primary
Rate of Progression on 7- Point Ordinal Scale
Rate of progression to the severe/critical COVID-19 disease
Time frame: First treatment date up to 28 days
Population: The Rate of progression to the severity of the disease was not identifiable as most of the subjects were discharged on Day 7 or 8
Primary
Rate of Progression on National Early Warning Score
Rate of progression to the severe/critical COVID-19 disease
Time frame: First treatment date up tp 28 days (28 days)
Population: The Rate of progression to the severity of the disease was not identifiable as most of the subjects were discharged on Day 7 or 8
Primary
Time to a Negative COVID-19 Nucleic Acid Testing
Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Time frame: Time Frame: First treatment date up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Product | Time to a Negative COVID-19 Nucleic Acid Testing | 5.47 days | Standard Deviation 0.49 |
| Placebo | Time to a Negative COVID-19 Nucleic Acid Testing | 6.97 days | Standard Deviation 0.61 |
Secondary
Change in Clinical or Laboratory Assessment of Comorbid Condition
To evaluate any decline in health condition due to comorbidity
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Change in Clinical or Laboratory Assessment of Comorbid Condition | 0 Participants |
| Placebo | Change in Clinical or Laboratory Assessment of Comorbid Condition | 0 Participants |
Secondary
ICU Admissions
Incidence of ICU admissions
Time frame: Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | ICU Admissions | 0 Participants |
| Placebo | ICU Admissions | 0 Participants |
Secondary
Incidence of Mechanical Ventilation
Number of incidences of mechanical ventilation due to COVID-19 infection
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Incidence of Mechanical Ventilation | 0 Participants |
| Placebo | Incidence of Mechanical Ventilation | 0 Participants |
Secondary
Percent of Participants With Worsening Comorbid Condition
Percent of participants with worsening comorbid condition.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Product | Percent of Participants With Worsening Comorbid Condition | 0 percentage | Standard Deviation 0 |
| Placebo | Percent of Participants With Worsening Comorbid Condition | 0 percentage | Standard Deviation 0 |
Secondary
Subject Survival
Subject survival in the trial
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Subject Survival | 59 Participants |
| Placebo | Subject Survival | 59 Participants |