In this study IMMUACTIVE would be compared with an inert substance, as a supplement in treatment of COVID-19 patients.

Not Applicable

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/09/027841
• Lead Sponsor: Sami Sabinsa Group Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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