Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J708- Respiratory conditions due to other specified external agents
Conditions
Interventions
Intervention1: Nuvastaticâ?¢ (C5OSEW5050ESA): Nuvastaticâ?¢ (C5OSEW5050ESA) in the form of powder to be reconstituted in water to be consumed thrice daily (morning, afternoon and evening (one sachet e
Sponsors
NatureCeuticals Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: Subject will be included in the study if all the below criteria are â??yesâ?? 1. Male and nonpregnant female patients 18 years of age or older eligible if they had a diagnostic specimen that was positive on RT-PCR. 2. For Mild â?? Moderate cases: Positive nasal swab test for Covid 19 at screening. 3. For Severe cases - Has an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg. 4. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Female subjects who are pregnant or breastfeeding. 2. Patients who are allergic to this medicine 3. Patients allergic to content of study product 4. Patients with diabetes. 5. Patients accompanied by serious physical diseases of heart, lung, brain, etc. 6. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study. 7. Patients who are not able to take drugs orally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first. 3. Change in standard diagnosis: Serum c-reactive protein (CRP), IgG, Hb, Total leucocyte count and differential leucocyte count. 4. Change in urinary F2-Isoprostane from baseline to remission Timepoint: Screening and Day14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical status as assessed with the seven-category ordinal scale on days 7 and 14, mortality at day 28. 2. The duration of mechanical ventilation. 3. The duration of hospitalization in survivors. 4. The time (in days) from treatment initiation to death. 5. Rate of recovery from positive to negative swabs Percentage of patients turned from positive to negative swabs at day 14. Timepoint: Screening and Day14 | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed