Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: IMMUACTIVE: One capsule daily after breakfast in the morning from Day1 to anytime during the study till 28Days.
Control Intervention1: Placebo - Microcrystalline cellulose: One capsule
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult male and female between 18 to 50 years of age with BMI less than or equal 35 kg/m2. 2 COVID-19 positive patients with or without co-morbid conditions (including comorbidity conditions viz diabetes mellitus, hypertension, if any) with ordinal scale score of less than or equal to 3 who requires hospitalization or admission to isolation ward. 3 Confirmed COVID-19 (SARS-CoV-2) infection by nasopharyngeal swab RT-PCR test within 48hrs. 4 Uncomplicated symptomatic COVID-19 patients in stable condition with peripheral capillary oxygen saturation (SpO2) >94% on room air at screening. 5 Subject (both literates and illiterates) willing to give signed informed consent.
Exclusion criteria
Exclusion criteria: 1 Asymptomatic COVID-19 positive patients. 2 Patient with ordinal scale of >=4 3 On Tube feeding or parenteral nutrition. 4 Admission to isolation ward or hospitalization >48hrs of confirmed COVID-19 positive test. 5 Patients on ventilator support. 6 Patients with uncontrolled, unstable comorbidities 7 Pre-existing or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease. 8 History of allergic reactions or anaphylaxis to investigational product components. 9 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or oral nutrition supplements. 10 Patients who are Immunocompromised or those on immunosuppressants 11 Pregnant and lactating females 12 Any other condition which the principal investigator thinks may jeopardize the safety of subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To compare the mean duration (days) for reduction in disease severity ordinal scale by 1 in patients supplemented with ImmuActive and placebo. 2 To compare the mean number of patients with reduction in disease severity by 1 ordinal scale in ImmuActive and placebo.Timepoint: 1 To compare the mean duration (days) for reduction in disease severity ordinal scale by 1 in patients supplemented with ImmuActive and placebo (Day1 to anytime during the study till 28Days). 2 To compare the mean number of patients with reduction in disease severity by 1 ordinal scale in ImmuActive and placebo (Day1 to anytime during the study till 28Days). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate no. of days taken to test negative for COVID-19 by RT-PCR in ImmuActive arm in comparison with Placebo. 2 To evaluate the safety of ImmuActive by the incidence of adverse events. 3 Compare mean days of hospitalisation/CCC between patients supplemented with ImmuActive and Placebo arms. 4 Compare change in modified Jackson symptom severity score between ImmuActive and Placebo arms. 5 Compare improvement in COVID-19 QOL between ImmuActive and Placebo arms.Timepoint: 1 No. of days taken to test negative by RT-PCR in both the arms (Anytime when the subjects tests negative or till 28Days). 2 Adverse event Monitoring (Throughout the study). 3 Compare mean days of hospitalisation(Anytime when the subjects tests negative or till 28Days). 4 Jackson symptom severity score(Day1,Day6 and apart from this whenever, RT-PCR test is conducted till 28Days). 5 QOL (Day1,Day6 and apart from this whenever, RT-PCR test is conducted till 28Days). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld (P) Limited
Outcome results
None listed