A study to assess the safety and efficacy of a nutraceutical formulation in addition to standard of care in COVID-19 positive patients.

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 28

Inclusion Criteria

Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â‰¥ 38 â„ƒ (100.4 Â°F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â‰¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats).
If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
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.
The onset of symptoms is defined as either: 3a.
Time of the first increase in body temperature to â‰¥ 38 â„ƒ (100.4 Â°F); or 3b.
Time when the subject experiences at least one general or respiratory symptom.
Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses).
Subjects who are able to understand and willing to sign the informed consent form (ICF).
Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures.
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

Severe COVID-19 infection.
History of Chronic Exposure to Smoking 3.
other concurrent infections requiring systemic antiviral therapy prior to screening.
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.
Allergy or known allergy to components of study medication (Peanuts and Mushroom).
Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the clinical efficacy of XAR-XAP treatment in reducing the duration and severity of illness compared to placebo	Day 0, Day 15, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Joshi Hospital
🇮🇳
Pune, MAHARASHTRA, India
Joshi Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Abhijeet Joshi
Principal investigator
9421217976
joshabhijeet@gmail.com