COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05096052

ALBEN SIGAMANI, MD

dralbens@myrescon.com

2021-10-27

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: male or female patient of ≥ 18 years of age, regardless of vaccine status or viral variant or underlying medical conditions, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule. patient having a positive diagnosis for the presence of sars-cov-2, obtained from a recently performed rrt-pcr (≤ 3 days) with any 1 of the following: i. ct value ≤ 25 ii. hospitalized for having classical (cdc defined) symptoms of covid-19 (onset ≤ 5 days) iii. high risk category of covid-19: blood group type a-positive type 2 diabetes, or other chronic disease known to have higher morbidity risk with sars-cov-2 infection. patient has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated swab collections and frequent follow up for 29 days. females of child bearing potential who has been using a highly effective contraception for at least 1 month prior to screening and agrees to continue using it during the study participation/enrolment, confirmed through negative pregnancy test

- 5. oxygen saturation levels (spo2) ≤ 94% on room air. 6. female patients who are pregnant or breastfeeding. 7. patients with any active malignancy or undergoing active chemotherapy. 8. patients who are currently receiving or have received any investigational treatment for covid-19 within 30 days prior to screening. 9. in the opinion of the investigator, the participation of the patient in the study is not in the patient's best interest, or the patient has any medical condition that does not allow the study protocol to be followed safely. 10. patients with known allergies to any of the components used in the formulation of the interventions.

2

Bioxytran Inc.

18

100

None

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

408

Change in clinical status from baseline;Change in seropositivity from baseline for-detection of viral shedding

None

Phase 3

[{"arm_notes": "", "treatment_id": 2025, "treatment_name": "Galactomannan", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]