Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection

Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.
Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.
Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.
Phase 2
Primary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Phase 3
Primary Objective:
To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Long COVID [Follow-up Phase- Objectives- (Phase 2 & 3)]
To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC

开始日期2022-11-10

申办/合作机构

Kare Biosciences Inc.

[+4]

CTRI/2022/11/047189 / Recruiting临床2/3期

A Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Multi-Centre, Adaptive Phase II/Phase III Study to Evaluate the Efficacy and Safety of Ramatroban along with the standard of care in Hospitalized Subjects with SARS-CoV-2 Infection. - RAMBAN-1

开始日期2022-11-10

申办/合作机构-

CTR20191475 / RecruitingN/A

雷马曲班片在中国健康志愿者中进行的人体生物等效性预试验

主要目的：观察中国健康志愿者在空腹/餐后服用受试制剂雷马曲班片（规格：75mg；生产企业：瑞阳制药有限公司）和参比制剂雷马曲班片（规格：75mg；生产企业：日本拜耳药品株式会社）后的药代动力学特征，评价空腹/餐后两种制剂的生物等效性。次要目的：观察受试制剂雷马曲班片和参比制剂雷马曲班片在中国健康志愿者中的安全性

开始日期2020-05-30

申办/合作机构

北京润德康医药技术有限公司

100 项与雷马曲班相关的临床结果

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100 项与雷马曲班相关的转化医学

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100 项与雷马曲班相关的专利（医药）

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155

项与雷马曲班相关的文献（医药）

2023-02-01·Inflammopharmacology

The effect of ramatroban on cytokine and thrombotic storms in Covid-19

Article

作者: Al-Kuraishy, Hayder M ; Saad, Hebatallah M ; Al-Gareeb, Ali I ; Batiha, Gaber El-Saber

A review.In severe Covid-19 with exaggeration of immune response and release of pro-inflammatory cytokines like interleukin-6, tumor necrosis factor-α, IL-1β and chemokines, cytokine storm is developed leading to acute lung injury, acute respiratory distress syndrome and multi-organ failure.Ramatroban through inhibition of TXA2/PGD2-induced release of pro-inflammatory cytokine and development of immunothrombosis might be effective in damping the development of a cytokine storm in Covid-19.Preclin. and clin. studies are necessary in this regard.

2023-02-01·Infectious disorders drug targets

Molecular Docking Analysis of Adhatoda vasica with Thromboxane A2 Receptor (TXA2R) (6IIU) and Antiviral Molecules for Possible Dengue Complications

Article

作者: thangaraju, Eswaran ; Ramamurthy, Vijayakumar Arumugam ; Gurunthalingam, Meenalochini Prakash ; Narasimhan, Gopinathan ; Venkatesan, Sajitha ; Yella, Sree Sudha Tanguturi ; Thangaraju, Pugazhenthan

Objective::

The present study is an in silico model of platelet amplification potential of Adhatoda vasica, which can be used to treat thrombocytopenia in dengue complications.

Methods::

Docking studies have proved to be an essential tool that facilitates the structural diversity of natural products to be harnessed in an organized manner. In the present study, vasicine containing natural anti-dengue potential was subjected to docking studies using Schrodinger glides software (ver.11.1). The docking study was carried out to find out the potential molecular targets for selected protein. The docking was carried out on different ligands, like vasicine, ramatroban, chloroquine, celgosivir, and standard eltrombopag downloaded from PubChem and retrieved to glide software and ligands prepared using lig prep wizard. Docking was performed using the ligand docking wizard of Glide-maestro 2018.

Results::

The docking score of vasicine (-5.27) is nearly identical to the standard eltrombopag (-6.08), and both ligands bind with one hydrogen bond. The validation score of ramatroban is -12.39, binding with five hydrogen bonds, Celgosivir exhibited a docking score of -7.3 with three hydrogen bonds, and chloroquine displayed no hydrogen bond but had a docking score of -4.6.

Conclusion::

Vasicine was found to be the most suitable target of platelet amplification potential from Adhatoda vasica. However, the molecular docking results are preliminary, and it has been indicated that vasicine could be one of the potential ligands to treat the thrombocytopenia of dengue; experimental evaluation will be carried out in the near future.

2022-01-01·Current opinion in nephrology and hypertension

Kidney in the net of acute and long-haul coronavirus disease 2019: a potential role for lipid mediators in causing renal injury and fibrosis

Review

作者: Gupta, Ajay ; Kalantar-Zadeh, Kamyar ; Chiang, Kate C. ; Imig, John D.

Purpose of review:

Severe COVID-19 disease is often complicated by acute kidney injury (AKI), which may transition to chronic kidney disease (CKD). Better understanding of underlying mechanisms is important in advancing therapeutic approaches.

Recent findings:

SARS-CoV-2-induced endothelial injury initiates platelet activation, platelet–neutrophil partnership and release of neutrophil extracellular traps. The resulting thromboinflammation causes ischemia–reperfusion (I/R) injury to end organs. Severe COVID-19 induces a lipid-mediator storm with massive increases in thromboxane A2 (TxA2) and PGD2, which promote thromboinflammation and apoptosis of renal tubular cells, respectively, and thereby enhance renal fibrosis. COVID-19-associated AKI improves rapidly in the majority. However, 15–30% have protracted renal injury, raising the specter of transition from AKI to CKD.

Summary:

In COVID-19, the lipid-mediator storm promotes thromboinflammation, ischemia–reperfusion injury and cytotoxicity. The thromboxane A2 and PGD2 signaling presents a therapeutic target with potential to mitigate AKI and transition to CKD. Ramatroban, the only dual antagonist of the thromboxane A2/TPr and PGD2/DPr2 signaling could potentially mitigate renal injury in acute and long-haul COVID. Urgent studies targeting the lipid-mediator storm are needed to potentially reduce the heavy burden of kidney disease emerging in the wake of the current pandemic.

项与雷马曲班相关的新闻（医药）

2022-10-05

·PRNewswire

BioLink Life Sciences, Charak Foundation and KARE Biosciences Announce contract for developing a novel treatment of COVID pneumonia and prevention of long COVID

CARY, N.C., Oct. 5, 2022 /PRNewswire/ -- BioLink Life Sciences of Cary, North Carolina, today announced receiving a contract from BARDA (the Biomedical Advanced Research and Development Authority) to fund the development of Ramatroban for treatment of patients hospitalized with COVID-19 pneumonia (the RAMBAN-1 Study). BioLink's $750,000 contract from BARDA complements a multimillion dollar grant from Open Philanthropy to the Charak Foundation. RAMBAN-1 is a Phase 2/3 randomized, placebo-controlled clinical trial to evaluate Ramatroban's safety and efficacy in speeding recovery in hospitalized patients with COVID-19 pneumonia with a 28-day course of treatment. RAMBAN-1 will also explore if the 28-day treatment of acute disease with Ramatroban reduces the risks of subsequent development of post-acute sequelae of COVID-19 ("long COVID") over the ensuing 11 months. This study, which will be carried out at multiple clinical sites in India, is expected to support an emergency use authorization by regulatory authorities in India for acute COVID-19 while laying the groundwork for future clinical trials treating both acute and long COVID in the United States. Ramatroban has been approved and used in Japan for over 20 years for treatment of allergic rhinitis by twice daily oral administration. In COVID-19 ramatroban targets pathways activated by massive increases in lipid mediators including thromboxane A2 and prostaglandin D2. Clinical investigators believe that thromboxane A2 slows the blood circulation through the lungs, reduces oxygenation of blood, and promotes blood clotting while prostaglandin D2 leads to misfiring of the immune system. In a ground-breaking case series, ramatroban use led to rapid and sustained relief of both acute respiratory distress and hypoxemia in outpatients with COVID-19 pneumonia, thereby avoiding hospitalization (Ogletree et al. 2022). The potential mechanism of action of ramatroban in COVID-19 has been reviewed recently (Chiang et al, 2022). Ajay Gupta MD, Chief Medical Officer of KARE Biosciences and head of the Charak Foundation stated, "We welcome the initiative by Open Philanthropy and BARDA to support development of therapeutic agents for the COVID-19 pandemic, agents that target disease development both for COVID-19 and perpetrators of future pandemics. Lipid mediators have been ignored as therapeutic targets in COVID-19 and many other diseases. Ramatroban is the only known dual receptor antagonist of both thromboxane A2 and PGD2 action. We hope to exploit the great potential of this drug for treatment of respiratory, neurological, cardiovascular, immunologic and other manifestations of SARS-CoV-2 and other infectious pathogens." Deanna Nelson PhD, President of BioLink stated, "We are very excited to repurpose a drug that has an established safety record over 20 years of use, is conveniently given twice daily by mouth to both inpatients and outpatients and is highly cost effective. If therapeutic benefits of Ramatroban are demonstrated successfully, the RAMBAN-1 study will serve as a springboard for application of this unique drug to treat both COVID-19 and many similar disease conditions that are characterized by a thromboxane-prostaglandin "storm" and platelet activation leading to thrombo-inflammation in conjunction with a dysregulated immune response." About Ramatroban: Ramatroban, a dual blocker of thromboxane and prostanoid receptors, has demonstrated efficacy in animal models of respiratory dysfunction, atherosclerosis, thrombosis, and sepsis, and preliminary evidence for rapid relief of dyspnea and hypoxemia in COVID-19 pneumonia. Ramatroban merits investigation as a promising antithrombotic and immunomodulatory agent for prophylaxis and treatment. About BioLink Life Sciences: BioLink Life Sciences is a North Carolina based clinical research company that develops novel, proprietary pharmaceutical products via multiple regulatory pathways. Its portfolio of patented products includes a line of supplements for general wellbeing and bone health, as well as late-stage drugs targeting large, unmet medical needs in renal and skeletal health. About Charak Foundation: Charak Foundation is a Southern California-based, privately operating, nonprofit foundation of Dr. Ajay Gupta. The foundation is dedicated to promoting health and education for the underprivileged and conducting medical research, with a focus on diseases that disproportionately affect the populations of developing or low-income countries. About KARE Biosciences: KARE Biosciences is an Orange County, California-based biotechnology company dedicated to repurposing drugs and discovering new small molecules to address unmet needs in a variety of medical areas, including rare diseases. The company is currently developing Ramatroban as a treatment for acute and long COVID-19, thrombotic disorders, silicosis, sickle cell disease, pulmonary hypertension, and other disorders. KARE Biosciences is also developing a novel, antihypertensive combination of indapamide, the best-in-class thiazide-like diuretic, in combination with a mineralocorticoid receptor antagonist (spironolactone or eplerenone). These combinations were patented by the Company in 2010. About Open Philanthropy and BARDA funding: Open Philanthropy has funded this project as one of a portfolio of grants in support of causes that are prioritized based on three criteria: importance, neglectedness, and tractability. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00068. SOURCE BioLink Life Sciences

合作小分子药物紧急使用授权

100 项与雷马曲班相关的药物交易

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