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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change In Clinical Status
研究概览
简要总结
ProLectin M is an orally administered polysaccharide. Polysaccharides competitively bind to the N-terminal tail of human galectin-3 through a proline isomerization [10]. Galetin-3 (Gal-3) is 1 among the 15 galectins described in humans and also a ubiquitous human galectin expressed in various disease pathogenesis pathways [11].
The objective of this clinical study is to evaluate the safety and efficacy of a galectin antagonist, ProLectin M (a Guar Gum Galactomannan), in the treatment of subjects with asymptomatic to moderately-severe, ambulatory COVID-19 patients.
详细描述
This trial will test the efficacy of ProLectin M in lowering viral load among those infected with SARS-CoV-2. Viral load will be measured using nucleic acid amplification-based diagnostics, RT-PCR. The RT-PCR will measure an absolute increase in cycle threshold values from baseline.
ProLectin M (a guar gum galactomannan), an oral form of galectin antagonist could treat COVID-19 patients. When given early in the disease pathogenesis and the viral replication is stopped, it can prevent further spread of SARS-CoV-2 among the household contacts and their community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinding will be maintained throughout the trial until database is locked after last patient last visit. Emergency unblinding will be allowed through a 24/7 helpline set up for any investigator / ethics committee member or others authorized to request for unblinding. Given
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria to be included in this study.
- •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.
- •Subject having a positive diagnosis for presence of SARS-CoV- 2, obtained from a recently performed RT-PCR (≤ 3 days) with a Ct value ≤
- •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
- •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.
排除标准
- •Patients who meet any of the following criteria will be excluded from this study.
- •Oxygen Saturation levels (SpO2) ≤ 94% on room air.
- •Female subjects who are pregnant or breastfeeding.
- •Subjects with any active malignancy or undergoing active chemotherapy.
- •Subjects who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
- •Subjects with a history of hypercalcemia or serum calcium concentration >10mg/dl
- •Subjects currently on concomitant medication that can contains calcium, elevate serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics etc.).
- •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.)
- •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.
- •Subjects with known allergies to any of the components used in the formulation of the interventions.
研究组 & 干预措施
Arm 1
ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg
干预措施: Prolectin-M (Drug)
Arm 2
ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg
干预措施: Prolectin-M (Drug)
Arm 3
ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800
干预措施: Prolectin-M (Drug)
结局指标
主要结局
Change In Clinical Status
时间窗: Day 7
Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
次要结局
- Time to discharge of viral load(from time of signing informed consent till day 14)
- Mortality(from time of signing informed consent till day 14)
- Plasma Concentration of PL-M(Day 7)
- Change in Clinical Status(Day 3 and Day 5)
- Change in Clinical Status from Baseline to End of the study(from time of signing informed consent till day 14)
- Safety Outcome(from time of signing informed consent till day 14)