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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
    ...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020) Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collec...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
    See more | Go to post

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  • 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, 02:56 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020) Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collec...
    12-05-2020, 08:02 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
    11-20-2020, 09:08 AM

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