In this study selenium levels would be determined in both normal volunteers as well as patients suffering from COVID-19.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026747
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
A) APPLICABLE FOR NORMAL SUBJECTS
1 Adult male and female between 18 to 45 years of age.
2 For normal subjects who currently have no signs and symptoms of any viral/bacterial infection; Body temperature between 97º to 99º F and SpO2 > 90%.
3 Literate subject willing to give signed informed consent.
B) APPLICABLE FOR COVIDâ??19 SUBJECTS
1 Adult male and female between 18 to 45 years of age.
2 Confirmed COVID-19 (SARS-CoV-2 ) infection by nasopharyngeal swab RT-PCR test on the same day.
3 COVID-19 patients in stable condition with fever, dyspnea without hypoxemia.
4 Literate subject willing to give signed informed consent.
A) APPLICABLE FOR NORMAL SUBJECTS
1 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or disease specific oral nutrition supplements.
2 Any other condition which the principal investigator thinks may jeopardize the safety of subjects.
B) APPLICABLE FOR COVID -19 PATIENTS
1 Asymptomatic COVID-19 positive patients.
2 On Tube feeding or parenteral nutrition.
3 Admission to isolation ward > 24hrs of confirmed COVID-19 positive test.
4 Patients on ventilator support.
5 Patients whose condition is unstable.
6 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or disease specific oral nutrition supplements.
7 Any other condition which the principal investigator thinks may jeopardize the safety of subjects.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 To analyze the selenium levels in blood and urine of symptomatic COVID-19 positive patients and normal adult subjects. <br/ ><br> <br/ ><br>2 To compare the mean selenium levels in blood and urine of COVID-19 positive patients and normal adult subjects.Timepoint: 1 Selenium levels in blood and urine of symptomatic COVID-19 positive and normal adult subjects (Post enrolment). <br/ ><br> <br/ ><br>2 Mean selenium level comparison in blood and urine of COVID-19 positive and normal adult subjects (Post enrolment).
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI