COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47174

Dr Kalpesh Shah

kalpesh@clinworld.org

2020-09-16

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1 Adult male and female between 18 to 50 years of age with BMI less than or equal 35 kg/m2. <br/ >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. <br/ >3 Confirmed COVID-19 (SARS-CoV-2) infection by nasopharyngeal swab RT-PCR test within 48hrs. <br/ >4 Uncomplicated symptomatic COVID-19 patients in stable condition with peripheral capillary oxygen saturation (SpO2) >94% on room air at screening. <br/ >5 Subject (both literates and illiterates) willing to give signed informed consent.

1 Asymptomatic COVID-19 positive patients. <br/ >2 Patient with ordinal scale of â?¥4 <br/ >3 On Tube feeding or parenteral nutrition. <br/ >4 Admission to isolation ward or hospitalization >48hrs of confirmed COVID-19 positive test. <br/ >5 Patients on ventilator support. <br/ >6 Patients with uncontrolled, unstable comorbidities <br/ >7 Pre-existing or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease. <br/ >8 History of allergic reactions or anaphylaxis to investigational product components. <br/ >9 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or oral nutrition supplements. <br/ >10 Patients who are Immunocompromised or those on immunosuppressants <br/ >11 Pregnant and lactating females <br/ >12 Any other condition which the principal investigator thinks may jeopardize the safety of subjects.

2

Sami Sabinsa Group Limited

18

50

India

Moderate disease at enrollment

3: Moderate disease at enrollment

100

1 To compare the mean duration (days) for reduction in disease severity ordinal scale by 1 in patients supplemented with ImmuActive and placebo. <br/ >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). <br/ >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).

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 633, "treatment_name": "Immuactive", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]