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 OrallyAdministered ProLectin-M - PROTECT

Pharmalectin Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•1. Male or Female patient of >=â??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. 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.
•3. 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 10 days.
•4. Females of childbearing potential who has been using highly effective contraception for at least 1 month prior to screening and agree continue using it during the study participation/enrolment,
•confirmed through negative pregnancy test

•1. Oxygen Saturation levels (SpO2) <= 94% on room air.
•2. Female patients who are pregnant or breastfeeding.
•3. Patients with any active malignancy or undergoing active chemotherapy.
•4. Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
•5. In the opinion of the Investigator, the participation of the patient in the study is not in the patientâ??s best interest, or the patient has
•any medical condition that does not allow the study protocol to be followed safely.
•6. Patients with known allergies to any of the components used in the formulation of the interventions.

发起方

Pharmalectin Inc