Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: XAR-XAP: 4 capsules of XAR-XAP thrice a day along with standard of care for 30 days
Route of administration: oral
Control Intervention1: Maltodextrin (placebo): 4 capsules of Maltodextr
Sponsors
Epigeneres Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature >= 38 â?? (100.4 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate >=24 breaths per minute or Saturation of Oxygen (SpO2) 2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. 3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either: 3a. Time of the first increase in body temperature to >= 38 â?? (100.4 °F); or 3b. Time when the subject experiences at least one general or respiratory symptom. 4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). 5. Subjects who are able to understand and willing to sign the informed consent form (ICF). 6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. 7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.
Exclusion criteria
Exclusion criteria: 1. Severe COVID-19 infection. 2. History of Chronic Exposure to Smoking 3. other concurrent infections requiring systemic antiviral therapy prior to screening. 4. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, and antiviral drugs during the previous 4 weeks before the first dose. Use of corticosteroids as part of the current standard of care is permitted. 6. Allergy or known allergy to components of study medication (Peanuts and Mushroom). 7. Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the clinical efficacy of XAR-XAP treatment in reducing the duration and severity of illness compared to placeboTimepoint: Day 0, Day 15, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of XAR-XAP treatment on the anti SARS-CoV-2 antibody levels in COVID-19 subjects on Day 0, Day 30, day 60 and day 90 To monitor long term protection (until 90 days) of COVID-19 patients with or without controlled diabetes and hypertension.Timepoint: Day 0, Day 15, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Nripen Sharma
Epigeneres Biotech Pvt. Ltd.
Outcome results
None listed