Logical Analysis Report

Key Focus

  • Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
    About the SIMPLE Trials
    Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
    The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19
  • Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19.
  • The results from the first 600 patients of this study are expected at the end of May.
    About Remdesivir
    Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
    About Gilead Sciences
    Gilead Sciences, Inc is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need
  • This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care."
    Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.

To understand how to read this report, please click here

Knowledge Graph(Read more)

Complex Event Analysis(Read more)

High Level Topics

  • REMDESIVIR
  • COVID-19
  • HOSPITAL
  • SAFETY

    • High Level Abstractions

  • REMDESIVIR(7, 0 Order)
  • ( REMDESIVIR )(7, 0 Order)  top
  • ( REMDESIVIR, COVID-19 )(4, 1st Order)  top
  • ( REMDESIVIR, SAFETY )(2, 1st Order)  top
  • ( REMDESIVIR, INVESTIGATIONAL )(1, 1st Order)  top
  • ( REMDESIVIR, HOSPITAL )(2, 1st Order)  top
  • ( REMDESIVIR, COUNTRIES )(1, 1st Order)  top
  • ( REMDESIVIR, VIRUS )(1, 1st Order)  top
  • ( REMDESIVIR, STANFORD_UNIVERSITY_SCHOOL )(1, 1st Order)  top
  • ( REMDESIVIR, SIMPLE_TRIALS )(1, 1st Order)  top
  • ( REMDESIVIR, RISKS )(1, 1st Order)  top
  • ( REMDESIVIR, OPEN-LABEL )(1, 1st Order)  top
  • ( REMDESIVIR, MULTI-CENTER )(1, 1st Order)  top
  • ( REMDESIVIR, MANIFESTATIONS )(1, 1st Order)  top
  • COVID-19(5, 0 Order)
  • ( COVID-19 )(5, 0 Order)  top
  • ( COVID-19, SAFETY )(1, 1st Order)  top
  • ( COVID-19, MANIFESTATIONS )(3, 1st Order)  top
  • ( COVID-19, INVESTIGATIONAL )(1, 1st Order)  top
  • ( COVID-19, SIMPLE_TRIALS )(1, 1st Order)  top
  • ( COVID-19, OPEN-LABEL )(1, 1st Order)  top
  • ( COVID-19, MULTI-CENTER )(1, 1st Order)  top
  • ( COVID-19, INTRAVENOUSLY )(1, 1st Order)  top
  • ( COVID-19, INFECTION )(1, 1st Order)  top
  • ( COVID-19, ENZYME )(1, 1st Order)  top
  • ( COVID-19, ELEVATIONS )(1, 1st Order)  top
  • ( COVID-19, DISCONTINUING )(1, 1st Order)  top
  • HOSPITAL(4, 0 Order)
  • ( HOSPITAL )(4, 0 Order)  top
  • SAFETY(3, 0 Order)
  • ( SAFETY )(3, 0 Order)  top

    • References

    • ( REMDESIVIR )  top
    • ( REMDESIVIR, COVID-19 )  top
    • (Read more)   top
      Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.
    • (Read more)   top
      Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
      The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19
    • (Read more)   top... models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
      About Gilead Sciences
      Gilead Sciences, Inc is a research-based...
    • (Read more)   top Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19.
    • ( REMDESIVIR, SAFETY )  top
    • (Read more)   top
      The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19
    • (Read more)   top... multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
      About Gilead Sciences
      Gilead Sciences, Inc is a research-based...
    • ( REMDESIVIR, INVESTIGATIONAL )  top
    • (Read more)   top ... press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19
    • ( REMDESIVIR, HOSPITAL )  top
    • (Read more)   top ... 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.
      Impact       of Earlier Treatment
      In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than...
    • (Read more)   top Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
      "These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar...
    • ( REMDESIVIR, COUNTRIES )  top
    • (Read more)   top
      Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
      The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe...
    • ( REMDESIVIR, VIRUS )  top
    • (Read more)   top... vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
      About Gilead Sciences
      Gilead Sciences, Inc...
    • ( REMDESIVIR, STANFORD_UNIVERSITY_SCHOOL )  top
    • (Read more)   top ... patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course," said Aruna Subramanian, MD, Clinical Professor of Stanford University School of Medicine, and one of the lead investigators of the study.
    • ( REMDESIVIR, SIMPLE_TRIALS )  top
    • (Read more)   top
      About the SIMPLE Trials
      Gilead       initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
      The first SIMPLE trial is...
    • ( REMDESIVIR, RISKS )  top
    • (Read more)   top
      This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use,...
    • ( REMDESIVIR, OPEN-LABEL )  top
    • (Read more)   top
      Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
      The first SIMPLE trial is evaluating the safety and efficacy of...
    • ( REMDESIVIR, MULTI-CENTER )  top
    • (Read more)   top
      Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
      The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day...
    • ( REMDESIVIR, MANIFESTATIONS )  top
    • (Read more)   top
      The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19.
    • ( COVID-19 )  top
    • ( COVID-19, SAFETY )  top
    • (Read more)   topSee ( REMDESIVIR , SAFETY )
    • ( COVID-19, MANIFESTATIONS )  top
    • (Read more)   top... today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment...
    • (Read more)   topSee ( REMDESIVIR , MANIFESTATIONS )
    • (Read more)   top
      A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.
      About Remdesivir
      Remdesivir is an investigational nucleotide...
    • ( COVID-19, INVESTIGATIONAL )  top
    • (Read more)   top Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19
    • ( COVID-19, SIMPLE_TRIALS )  top
    • (Read more)   topSee ( REMDESIVIR , SIMPLE_TRIALS )
    • ( COVID-19, OPEN-LABEL )  top
    • (Read more)   topSee ( REMDESIVIR , OPEN-LABEL )
    • ( COVID-19, MULTI-CENTER )  top
    • (Read more)   topSee ( REMDESIVIR , MULTI-CENTER )
    • ( COVID-19, INTRAVENOUSLY )  top
    • (Read more)   top
      A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.
      About Remdesivir
      Remdesivir...
    • ( COVID-19, INFECTION )  top
    • (Read more)   top
      Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
      The       first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19
    • ( COVID-19, ENZYME )  top
    • (Read more)   top Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
      About the SIMPLE Trials
      Gilead...
    • ( COVID-19, ELEVATIONS )  top
    • (Read more)   top Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
      About the SIMPLE Trials
      Gilead...
    • ( COVID-19, DISCONTINUING )  top
    • (Read more)   top Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
      About the SIMPLE Trials
      Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies,...
    • ( HOSPITAL )  top
    • (Read more)   top Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital. In...
    • (Read more)   top More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of...
    • (Read more)   top ... 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital. Impact of Earlier Treatment In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than...
    • (Read more)   top Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late. "These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar...
    • ( SAFETY )  top
    • (Read more)   top... treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 - 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks. "Unlike traditional...
    • (Read more)   top ... randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection. The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19
    • (Read more)   top... multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials. About Gilead Sciences Gilead Sciences, Inc is a research-based...