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  • Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy

    Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy| site |


    NIH trial has begun enrolling participants.


    (Information contained in National Institutes of Health [NIH] press release dated: February 8, 2021) An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). Antibodies are infection-fighting ...
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  • Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released

    Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released | site |



    (Information contained in National Institutes of Health [NIH] press release dated: January 29, 2021) An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months. The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infecte...
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  • FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff

    U.S. Food and Drug Administration Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff | site |


    Impact on molecular tests remains low


    (Information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021) The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taki...
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  • NIH says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19

    National Institutes of Health says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19 | site |



    (Information contained in National Institutes of Health [NIH] press release: January 5, 2021)

    A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol
    ...
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  • NIH says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials

    National Institutes of Health says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials | site |


    NIH trial enrolling people hospitalized with COVID-19


    (Information contained in National Institutes of Health [NIH] press release: December 17, 2020) Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). T...
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  • Monitoring Board says Trial Data suggests Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

    NIH: Monitoring Board says Trial Data suggests Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine| site |


    (November 16, 2020) - - Today the National Institutes of Health (NIH) published the following information: An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. ...
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  • FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




    (November 9, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
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  • NIH begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19

    National Institutes of Health begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19 | site |





    (October 16, 2020) - - Today, October 16, 2020, The National Institutes of Health (NIH) published the following information:

    The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive
    Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Graphic courtesy NIAID
    amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome,...
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  • BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments

    BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments | site |


    ACTT-3 Study Will Continue for Hospitalized Participants with Less Severe Illness


    Editor's note: Please note that this BULLETIN was published on September 29, 2020


    (September 29, 2020) - - On September 29, 2020, the National Institute of Allergy and Infectious Diseases published the following information:

    The Adaptive COVID-19 Treatment Trial 3 (ACTT-3), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will no longer enroll hospitalized participants with severe COVID-19 requiring high-flow oxygen, and will not begin to enroll patients requiring non-invasive or invasive mechanical ventilation. This action is being taken after an interim review of safety data by the study’s Data and Safety Monitoring Board (DSMB)
    ...
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  • Lilly Statement on the National Institute of Allergy and Infectious Diseases Decision to Pause Enrollment in ACTIV-3 Clinical Trial

    Lilly Statement on the National Institute of Allergy and Infectious Diseases Decision to Pause Enrollment in ACTIV-3 Clinical Trial | site |



    (October 14, 2020) - - Lilly (the Eli Lilly Company) has published a statement addressing the National Institute of Allergy and Infectious Diseases (NIAID) decision to Pause Enrollment in ACTIV-3 Clinical Trial.

    The Lilly statement is located at https://www.lilly.com/news/stories/s...use-enrollment or please press HERE
    ...
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  • NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins

    National Institutes of Health Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins | site |


    Editor's note: Please note that this article was published on October 8, 2020

    (October 8, 2020) - - On October 8, 2020, the National Institutes of Health (NIH) published the following information:

    A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National


    Graphic courtesy NIH/NIAID
    Institute of Allergy...
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  • NIH Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials

    National Institutes of Health Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials | site |



    (October 13, 2020) - - Today, the National Institutes of Health published the following information:

    The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show




    This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S.
    Graphic courtesy NIAID

    promise against COVID-19 and merit...
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  • Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials

    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials | site |



    (October 12, 2020) - - Today, October 12, 2020, Johnson & Johnson published the following information:



    Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials


    At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.

    We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines,
    ...
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  • NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19

    National Institutes of Health expands Clinical Trials to Test Convalescent Plasma against COVID-19 | site |


    Rigorous studies to build on earlier efforts to test the experimental treatment


    (September 22, 2020) - - Today the National Institutes of Health published the following information: Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and
    ...
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  • National Institutes of Health Clinical Trial of Investigational Vaccine for COVID-19 begins

    National Institutes of Health Clinical Trial of Investigational Vaccine for COVID-19 begins| site |


    Study enrolling Seattle-based healthy adult volunteers.


    (March 16, 2020) - - Today (March 16, 2020), the National Institutes of Health (NIH) published the following information:

    A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today. The study is evaluating different doses of the experimental vaccine for
    ...
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  • Staff Reporter 1
    Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy
    by Staff Reporter 1
    Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy| site |


    NIH trial has begun enrolling participants.


    (Information contained in National Institutes of Health [NIH] press release dated: February 8, 2021) An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). Antibodies are infection-fighting ...
    02-09-2021, 01:10 AM
  • Staff Reporter 1
    Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released
    by Staff Reporter 1
    Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released | site |



    (Information contained in National Institutes of Health [NIH] press release dated: January 29, 2021) An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months. The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infecte...
    01-31-2021, 04:45 AM
  • Staff Reporter 1
    FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
    by Staff Reporter 1
    U.S. Food and Drug Administration Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff | site |


    Impact on molecular tests remains low


    (Information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021) The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taki...
    01-08-2021, 10:19 PM
  • Staff Reporter 1
    NIH says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19
    by Staff Reporter 1
    National Institutes of Health says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19 | site |



    (Information contained in National Institutes of Health [NIH] press release: January 5, 2021)

    A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol
    ...
    01-06-2021, 01:56 AM
  • Staff Reporter 1
    NIH says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials
    by Staff Reporter 1
    National Institutes of Health says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials | site |


    NIH trial enrolling people hospitalized with COVID-19


    (Information contained in National Institutes of Health [NIH] press release: December 17, 2020) Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). T...
    12-18-2020, 01:51 PM

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