Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female between 20 to 65 years (both inclusive) of age at the time of enrolment. 2. Subject or LAR providing written informed consent and agrees to follow study procedure. 3. Woman with child bearing potential confirming use of primary contraception. 4. Mild to moderate freshly confirmed COVID 19 positive report within 24-48 hours not requiring emergency or ICU care at the time of enrolment and are required to be admitted to the hospital (Dedicated Covid Health Centre) for treatment.
Exclusion criteria
Exclusion criteria: 1. Severe COVID 19 positive subjects requiring ventilation or oxygen support when diagnosed. 2. Females who are planning to conceive during the study duration or are pregnant already or are breastfeeding. 3. Subjects having serious or unstable respiratory disorders (selfreported). 4. Subject already on immune therapy (self-reported). 5. History of Immunodeficiency or organ transplant (self-reported). 6. Presence of Autoimmune disease (self-reported). 7. Current acute infection or exacerbation of a chronic illness (selfreported). 8. Cancer within last 5 years (self-reported). 9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported) 10. Drug abuse/alcohol abuse (self-reported). 11. Patients with severe cardiac pathologies or any chronic illness or comorbid illness (self-reported). 12. Patients on treatment for Diabetes Mellitus. 13. Patients with the history of neurological or psychiatric illness (selfreported). 14. Receiving blood or immunoglobulins within 3 months (selfreported).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Faster Recovery: clinical symptoms and subjectâ??s critical state defined on 7-point ordinal scale. 2. Stress: measured by DASS scale 3. Mental Health: measured through a self-perception Hamilton Anxiety Scale 4. General Well-being/Systemic Health: measured through a self perception WHO 5 wellbeing scale 5. Happy Hormones (Dopamine and Serotonin 6. IgG 7. T-Lymphocyte Counts: CD4 T cells and CD8 T cells 8. Anti-viral property: RT-PCR 9. Antiallergic activity: IgE and CRP Timepoint: Enrollment -Discharge - plus 14 days of Follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SGOT and SGPT level measured at baseline and discharge. 2. Occurrence of any AE or SAE. 3. HRQOL.Timepoint: Enrollment -Discharge - plus 14 days of Follow up | — |
Countries
India
Contacts
Jagdale Industries Pvt Ltd