COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56607

Dr Nripen Sharma

sagar@epigeneres.com

2021-07-06

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °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. <br/ >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. <br/ >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: <br/ >3a. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F), or <br/ >3b. Time when the subject experiences at least one general or respiratory symptom. <br/ >4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). <br/ >5. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ >6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ >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. <br/ >

1. Severe COVID-19 infection. <br/ >2. History of Chronic Exposure to Smoking <br/ >3. other concurrent infections requiring systemic antiviral therapy prior to screening. <br/ >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. <br/ >6. Allergy or known allergy to components of study medication (Peanuts and Mushroom). <br/ >7. Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.

2

Epigeneres Biotech Pvt Ltd

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

28

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

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1887, "treatment_name": "Xar-xap", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]