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Researchers: Submit Pilot Study Concepts to Columbia Clinical Trials Network

Deadline Aug. 1   The Lyme Disease Association Inc. is notifying researchers that the Clinical Trials Network established with a grant from the Steven & Alexandra Cohen Foundation to Columbia University announces that the website is now accepting Pilot Study Concept submissions (July 1 to Aug 1).  

The Clinical Trials Network welcomes research clinicians and investigators from academic institutions and foundations to submit proposals. The CTN Study Review Committee will review submissions for consideration for further development into a pilot study; each pilot study will be conducted at one of the CTN investigation sites.  The CTN has funding to support 1-2 small pilot studies each year.  Current CTN network affiliates include investigators from Columbia University Irving Medical Center in New York City, Johns Hopkins University Medical Center in Baltimore Maryland, and Children’s National Hospital in Washington D.C.  The CTN Study Review Committee includes the core CTN members, clinical research experts, and academic and community clinicians. Results of the CTN pilot studies – if favorable – will lead to consideration for larger Randomized Controlled Trials.    

The deadline for the first round of submissions for treatment research ideas from the research scientists and clinicians is August 1, 2021.  The submission period opens July 1.   

We thank all clinicians and investigators in advance for participation in this process, as your proposal may lead to a transformative study. 

To submit a Pilot Study Proposal:  


 

To find out more information about the Network, go to the Lyme Disease Association link below.

Read about the establishment of the Network

 




Columbia Clinical Trials Network Seeks Treatment Approaches From Public, Clinicians, & Others

From Columbia Clinical Trials Network: In recognition of a severe unmet need, the Steven and Alexandra Cohen Foundation’s grant to Columbia University has established the first national Columbia Clinical Trials Network for Lyme and other Tick-borne Diseases [www.lymectn.org]. The Research Network starts with a team of leading investigators, including Dr. Brian Fallon at Columbia University Irving Medical Center in New York City, Dr. John Aucott at Johns Hopkins University Medical Center in Baltimore Maryland, and Dr. Roberta DeBiasi at Children’s National Hospital in Washington D.C.

Providing oversight to ensure that the highest-quality clinical trials are undertaken, the Clinical Trials Network will provide internal funding support for small pilot studies, assist investigators in protocol design and statistical research planning, establish and manage a national case registry, and create a data management system for multi-site clinical trials. The clinical trials network will be a powerful engine to drive large-scale clinical trials and potentially transformational early-stage research.

To generate as many ideas as possible and to hear directly from the front lines of clinical experience, Columbia CTNCC invites public, community clinicians, and other stakeholders to submit their ideas on treatment approaches. These ideas may spark off development of a pilot study and be included in clinical trials conducted at one of the CTN nodes.

You may contribute to a groundbreaking research project in the field of Lyme and the tick-borne diseases.

The deadline for the first round of submissions for treatment research ideas from the general public is July 1, 2021. The submission period opened June 1.

To submit your suggestions for treatments, please go to www.lymectn.org and submit on the “Treatment Research Idea Hub”.

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From the LDA:  The Lyme Disease Association Inc (LDA) President Pat Smith, had this to say about the release, “This is a great opportunity for individuals to provide suggestions which might lead to research on a treatment which could lead to a cure or to a better life for many of our sickest Lyme/TBD patients. I hope those who have promising ideas will submit them to the Columbia CTNCC for consideration.”

 

 

 




U of Maine Seeks Citizen Scientists

As a follow-up to its 2020 report from its 2020 citizen science project, the Maine Forest Tick Survey at the University of Maine is recruiting forest landowners in nine southern and coastal Maine counties to begin sampling for ticks in July 2021 when tick nymphs become active. The 2020 project collected 1643 ticks, and 445 of those blacklegged nymphs were tested for pathogens. 25+% were carrying Borrelia burgdorferi, 7% anaplasma phagocytophilum, and 5% Babesia microti.  Information on the Survey and how to volunteer can be found https://umaine.edu/forestticksurvey/  or by contacting citizen science coordinator elissa.ballman@maine.edu

For more information

Read full article here 

Forest Tick Survey Here 




Missouri Tick Study: Citizen Tick Submissions Requested

Photo by J. Occi, PhD (cand.), Rutgers Univ.

The Missouri Department of Conservation (MDC) and A.T. Still University are partnering on a Missouri tick study. This two-year research study is designed to better understand the distribution and species of ticks as well as the pathogens that they carry throughout Missouri. The study will run from April 2021 through September 2022.

During that time, MDC and the University are asking for citizens of Missouri to collect, save, and mail ticks that they encounter to A.T. Still University. To learn more about the research, submission directions, or to submit questions online visit atsu.edu/ticks.

Read full MDC news release here.

For additional LDA articles on tick and tick-borne disease studies/clinical trials visit here.

NOTE: The Lyme Disease Association, Inc.(LDA) thanks Lyme Association of Greater Kansas City (LAGKC) for this information. LAGKC is an affiliate partner of the LDA.  




Patients Win! Columbia Gets $16M to Establish Treatment Center/Trials Network

Dr. Brian Fallon
Brian Fallon, MD

A new center at Columbia University will open this summer to patients. The Cohen Center for Health & Recovery from Tick-Borne Diseases has been established through a $16M grant from the Steven & Alexandra Cohen Foundation to Columbia. Brian Fallon, MD, will be Center Director, Shannon Delaney, MD, co-director. Patients at the Center will be invited to enroll in clinical trials, brain imaging and neuropsychiatric studies. Physicians will be invited to annually submit treatment study ideas to the trials network for consideration.

Lyme Disease Association Pat Smith had this to say:  “This is the best possible news for patients who have been neglected for decades by much of the medical community. Often unable to get a timely diagnosis and appropriate treatment, many patients have gone on to develop chronic Lyme disease, facing debilitating manifestations, which have prevented them from working or going to school and even causing death.  Having a Treatment Center, a Clinical Trials Network, and a Research Center in one institution will certainly provide a three prong attack on a disease causing 476,000 people annually to be diagnosed and treated in the U.S.–Lyme disease–and allows for other tick-borne diseases to be addressed at the same time. ”

Dr. Fallon is also Director of the Columbia Lyme & Tick-Borne Diseases Research center, which was established in 2008 by the Lyme Disease Association Inc. and Time for Lyme (now GLA).

Thanks to the Cohen Foundation!   Congratulations to Drs. Fallon and Delaney!
 
 
 



Research Trial Seeks Participants: Fluvoxamine for Early COVID Treatment

A randomized research study sponsored by Washington University School of Medicine seeks participants age 30 and older, who have tested positive for COVID-19, and are currently experiencing mild symptoms. 

The purpose of the study is to determine if the drug fluvoxamine can be used during the early onset of COVID-19 infections to prevent more severe symptoms such as shortness of breath. Fluvoxamine is an anti-depressant drug approved by the US Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder. The FDA has not approved fluvoxamine for COVID-19 treatment and therefore its use for the treatment of COVID-19 is considered investigational.

The study will be entirely remote, meaning that there will be no face-to-face contact. Materials, including the study drug, will be shipped to participants’ houses. All communication and interactions will be done via videoconferencing, email, or phone. People living in the United States and Canada can participate.

Visit Clinicaltrials.gov for more information, including participation criteria.

Study Contact: Contact: Angela Stevens (314) 362-6291, stevens.a@wustl.edu

Learn the risks and potential benefits of participating in clinical studies.




New Dapsone Study: Breaking Biofilm

Dr. Richard Horrowitz co-author of the published case study on Lyme disease and COVID-19
Dr. Richard Horowitz, lead-author: Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi

New in vitro study on dapsone (diaminodiphenyl sulfone), and dapsone combination therapy (DDS CT) was just published by Dr. Richard Horowitz et al. and provides hope of effective treatment for patients with persistent Lyme disease.

The study is suggestive that dapsone combination therapy may well characterize both a novel and successful option to treat Borrelia burgdorferi persister cells in the form of biofilm.  There are several hypotheses causing great controversy regarding the persistent symptoms that greater than 10-20% of patients are experiencing after infection with B. burgdorferi. The study evaluated the effectiveness of dapsone against B. burdorferi biofilm forms of the bacteria by testing in individual as well as in combination therapy with several drugs including cefuroxime, doxycycline, rifampin, and azithromycin in vitro.

The results were robust, showing that using dapsone alone or in various combinations with the above stated drugs significantly reduced the mass and protective glycosaminoglycan layer affecting the capability of the biofilm form of B. burdorferi. DDS CT efficacy on the B. burgdorferi biofilms was also determined by ascertaining the biofilm polysaccharide matrix content, glycosaminoglycans (GAG).

Study results showed the most efficient single use antibiotic at reducing biofilm was dapsone at both 10 µM and 50 µM concentrations,  showing 69% and 58% residual viability respectively. Used individually, other antibiotic treatments (doxycycline, cefuroxime, and azithromycin) proved to be less efficient and, in some cases, even caused an increase biofilm mass. In contrast, triple and quadruple combination antibiotic therapies showed greater efficacy. The most significant finding was that dapsone used individually or in combination therapy with rifampin, and a tetracycline and/or a macrolide and/or a cephalosporin showed great promise in the treatment of persistent Lyme patients, with prior clinical studies demonstrating improvement in many of the debilitating symptoms that patients suffer including fatigue, pain, neuropathy, sleep disturbances, cognitive dysfunction, sweats and flushing. It is urgent that randomized trials are launched to evaluate the clinical effectiveness of DDS CT as the spread of Lyme disease continues to increase on a global scale.

Read the full journal article: Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi

Read the 2016 article: The Use of Dapsone as a Novel “Persister” Drug in the Treatment of ChronicLyme Disease/Post Treatment Lyme Disease Syndrome




Lyme & Pregnancy Research Study

Click here for detailed information on the Lyme & pregnancy research questionnaire/survey and to participateThe issue of Lyme disease and pregnancy is a serious one, and much more research and education is needed to understand the extent and scope of the problems related to pregnancy and Lyme. The Lyme Disease Association (LDA) is providing information on a study on Lyme and Pregnancy which is led by researchers from the McMasters Midwifery Research Centre in Canada.

The LDA does not recommend or endorse the study but provides the information as a service to those who may want to participate.

Click here for detailed information on the research questionnaire/survey and to participate

Click here for LymeHope update




Hydroxychloroquine for Early COVID Studies: Participants Needed

The following is a list of studies using Hydroxychloroquine for early COVID disease compiled from ClinicalTrials.gov on April 24, 2020.

Studies using Hydroxy + Azithromycin:

  • Rutgers, The State University of New Jersey
    Hydroxy + Zith vs Hydroxy alone vs. no treatment
    PCR + with T 100.6 or more
    Inpatient or outpatient
    Recruiting
  • LCMC Health (New Orleans)
    Hydroxy + azith vs. hydroxy alone vs supportive
    Early disease (<7 days of symptoms, PCR +) in 2 groups-
    Early moderate (O2 sat 94+) to severe disease (O2 sat<94)
    Viral load and clinical
    Recruiting

Hydroxy only studies (without azithro):

  • ProgenaBiome (CA-based PCR lab)
    Pre-exposure in health care workers
    Hydroxy + vite C + vite D = Zinc vs. no treatment- no doses listed
  • Baylor
    Hydroxy only
    Pre-exposure professional healthcare workers
    PCR q wk X 7; weeks, enroll by invitation
  • Elizabeth Oelsner, Columbia University
    Hydroxy only; placebo-controlled
    Post-exposure professional to housemates
    Not yet recruiting
  • Hackensack Meridian Health
    Hydroxy only, open-label, no placebo
    Pre-exposure professional health care workers
  • Washington University School of Medicine
    Hydroxy only- testing 3 different doses
    Pre-exposure; healthcare workers
    Not yet recruiting
  • University of Minnesota
    McGill University Health Centre/Research Institute of the McGill University Health Centre
    University of Manitoba
    University of Alberta
    Exposure or early disease <4 days of symptoms
    Hydroxy only vs. Placebo
    Recruiting
  • Montefiore Medical Center
    Early disease, confirmed + or suspect
    Hydroxy only
    Not yet recruiting
  • Providence Health & Services
    Hydroxy vs. Vitamin C
    Early disease- outpatients, PCR + By invitation
  • GeoSentinel Foundation
    Pre-exposure professional health care workers
    Hydroxy vs. placebo
    Not yet recruiting

Thank You Joseph Burrascano, MD for compiling this reference list.

Disclaimer: The Lyme Disease Association Inc. (LDA) provides this information as a public service. LDA does not necessarily endorse any of the studies or recommend participation in any studies. Participants need to review the information on the studies and make their own decisions regarding participation.




Lyme Campaign Seeks Participants ‘Resilient’ to Lyme & TBD

Lab Technician working with petri dishesMount Sinai researchers have launched a new app in conjunction with the Lyme and Tick-borne Disease Campaign, a project to identify people who seem to be resistant or resilient to ticks and tick-borne diseases including Lyme disease. The Lyme Campaign is seeking thousands of participants, in an effort to find new prevention or treatment strategies for Lyme and tick-borne diseases.

Below are examples of people the Lyme Campaign is interested in:

    • Individuals with laboratory test results that indicate an exposure to the bacteria that cause Lyme disease (positive Lyme disease blood test), but who have never been treated with antibiotics and lack typical signs and symptoms of the disease.
    • Individuals with high exposure to ticks—such as forestry workers, gardeners, or landscapers—who either experience bite reactions including pain, swelling, and itching, or those who become immune to ticks and are no longer bitten by bugs.

The campaign will be collaborating with Ben Luft, MD, at the Stony Brook University School of Medicine; Uri Laserson, PhD, Assistant Professor of Genetics and Genomics Sciences at the Icahn School of Medicine at Mount Sinai; and George Church, PhD, and Ting Wu, PhD, Professors of Genetics at Harvard Medical School.

The Lyme Campaign is the first effort of The Resilience Project, which studies individuals who believe they are resilient to a specific disease or health condition. These are people who seem protected against illness or more able than most to recover. These individuals may have been exposed to a germ or have genetic predisposition for a disease—but lack typical signs or symptoms.

Read the Mount Sinai Press Release

Disclaimer: The Lyme Disease Association Inc. (LDA) provides this information as a public service. LDA does not necessarily endorse any of the studies or recommend participation in any studies. Participants need to review the information on the studies and make their own decisions regarding participation.