A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M - NI

Pharmalectin Inc, USA.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Male or Female subject of = 18 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule.
•2.Subject having a positive diagnosis for presence of SARS-CoV- 2, obtained from a recently performed RT-PCR (= 3 days) with a Ct value = 25.
•3.Subject has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated nasopharyngeal swab collections and follow up till day 14.
•4.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.

•1.Oxygen Saturation levels (SpO2) = 94% on room air.
•2.Female subjects who are pregnant or breastfeeding.
•3.Subjects with any active malignancy or undergoing active chemotherapy.
•4.Subjects who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
•5.Subjects with a history of hypercalcemia or serum calcium concentration >10mg/dl
•6.Subjects currently on concomitant medication that can contains calcium, elevate serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics etc.).
•7.Subjects currently on calcium-binding (chelation) concomitant medication that may result in reduction in absorption (e.g. fluroquinolone, bisphosphonates, antivirals such as integrase strand transfer inhibitors, antibiotics such as quinolones, tetracyclines etc.)
•8.In the opinion of the Investigator, the participation of the subject in the study is not in the subject’s best interest, or the subject has any medical condition that does not allow the study protocol to be followed safely.
•9.Subjects with known allergies to any of the components used in the formulation of the interventions.

发起方

Pharmalectin Inc, USA.