PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety Among Asymptomatic to Moderately-severe, Ambulatory Patients.
试验速览
- 阶段
- 3 期
- 入组人数
- 408
- 主要终点
- Change in seropositivity from baseline for-detection of viral shedding
研究概览
简要总结
A galectin antagonist prevents viral entry of Sars-CoV-2 virus by blocking the specific terminal on the surface receptors that enables the virus to enter human cells. This inhibitor - ProLectin M is a novel substance that is given orally to individuals who have an infection with Sars-CoV-2 or its subsequent mutations causing COVID19 disease. The oral tablet is chewed every hour, for 8 hours daily, for 7 days.
We hypothesize that patients receiving the active investigational product (ProLectin M), irrespective of their vaccination status, or underlying medical conditions, will have a faster recovery from COVID19 compared to those receiving its matching placebo. The trial is approved by an Institutional Review Board for safety and all participants will need to provide written informed consent to participate in this trial. The safety of ProLectin M is established as the drug substance is recognised as a safe substance. However, its benefits in relieving patients from the COVID19 infection and providing the patients faster recovery from its clinical symptoms and prevention of delayed sequelae of the infection has not been proven yet.
详细描述
SarsCov2 causes inflammation by releasing cytokines. This is caused by the expressed galectins which are immunogenic.
Binding of the virus to human galectins also give it a very unique property to stealthily avoid the human innate immune system. This is the reason why even present day vaccines are failing to prevent spread of infections.
In this background, our investigational drug has the unique ability to mimic human Galectin 3 and prevent viral entry into host cells. This makes the virus vulnerable to our natural innate immune system to clear it from the oro pharyngeal and GITract.
Randomizing patients into active and placebo groups in a blinded placebo controlled trial can provide us evidence on the ability of ProLectin M to eliminate the virus and prevent even spread of the virus in the community. This also will demonstrate for the first time, how carbohydrates can be used to block significantly infection causing viruses in human beings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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
排除标准
- •Oxygen Saturation levels (SpO2) ≤ 94% on room air.
- •Female patients who are pregnant or breastfeeding.
- •Patients with any active malignancy or undergoing active chemotherapy.
- •Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
- •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.
- •Patients with known allergies to any of the components used in the formulation of the interventions.
研究组 & 干预措施
ProLectin M
Active chewable tablets containing galectin inhibitor complex carbohydrate
干预措施: Galactomannan (Drug)
PLACEBO
Placebo chewable tablets not containing galectin inhibitor complex carbohydrate
干预措施: PLACEBO (Drug)
结局指标
主要结局
Change in seropositivity from baseline for-detection of viral shedding
时间窗: 14 days
detecting quantitative SARS-CoV-2 in nasopharynx at intervals of days 1,2, 3, 5, 7, 9 and 14
Change in clinical status from baseline
时间窗: 14 days
Proportion of patients reporting improvement in their disease on a WHO Clinical Progression Scale measured daily over the course of the study
次要结局
- time to discharge or to a NEWS of ≤ 2(29 days)
- Duration of hospitalisation(29 Days)
- mortality / Serious adverse events(29 Days)
研究者
DR ALBEN SIGAMANI
Consultant MD Physician
Bioxytran Inc.