1. Fauci statements below. and CNBC video here: https://twitter.com/nbcnews/status/1255541788154224641?s=21 - NYT: FDA to announce Emergency Use of remdesivir as early as Wednesday 2. 北京这次怎么这么恶心啊。刚出了好消息，然后就把在中国的“failed" study 结果贴在了lancet上。你们这些人，做事要有点良心。一次次刷底线，要脸么？ 3. 这个帖子一下子看出来需要屏蔽的id是什么。
两个Gilead自己的发布：
1. 第一个。这个是美国政府的双盲。
Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences. Inc. (Nasdaq: GILD) is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.
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. Gilead will share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May from the second SIMPLE study evaluating the 5- and 10-day dosing durations of remdesivir in patients with moderate COVID-19 disease.
Gilead will continue to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19.
2.randomized trial Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences, Inc. (Nasdaq: GILD) 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 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 drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. 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. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. 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 this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. 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 patients in the 10-day treatment group achieved clinical recovery.
Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 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 10 days of symptoms. 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 clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). 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.
Key efficacy and safety results from the study are included in the table below.
5-Day RDV 10-Day RDV Baseline adjusted n=200 n=197 p-value^1 Clinical Efficacy Outcomes at Day 14 ≥ 2-point improvement in ordinal scale 129 (65) 107 (54) 0.16 Clinical recovery 129 (65) 106 (54) 0.17 Discharge 120 (60) 103 (52) 0.44 Death 16 (8) 21 (11) 0.70 Safety Any adverse event (AE) 141 (71) 145 (74) 0.86 Grade ≥3 study drug-related AE 8 (4) 10 (5) 0.65 Study drug-related serious adverse 3 (2) 4 (2) 0.73 event (SAE) AE leading to discontinuation 9 (5) 20 (10) 0.07
^1Adjusted for baseline clinical status
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. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10, administered intravenously, in addition to standard of care. An expansion phase of the study was recently added and will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
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.
quick note from an analyst: "This is earlier than expected Most important study we are aware of. Has a placebo. This is the trial run by the govt – NOT the GILD trial we were expecting results out today or tomorrow. This was NOT just in severe patients. This is MODERATE and severe It hit the primary endpoint which means it hit the efficacy end point which for dummies means it works. "
Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences. Inc. (Nasdaq: GILD) is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.
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. Gilead will share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May from the second SIMPLE study evaluating the 5- and 10-day dosing durations of remdesivir in patients with moderate COVID-19 disease.
Gilead will continue to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19.
2.randomized trial Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences, Inc. (Nasdaq: GILD) 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 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 drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. 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. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. 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 this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. 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 patients in the 10-day treatment group achieved clinical recovery.
Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 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 10 days of symptoms. 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 clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). 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.
Key efficacy and safety results from the study are included in the table below.
5-Day RDV 10-Day RDV Baseline adjusted n=200 n=197 p-value^1 Clinical Efficacy Outcomes at Day 14 ≥ 2-point improvement in ordinal scale 129 (65) 107 (54) 0.16 Clinical recovery 129 (65) 106 (54) 0.17 Discharge 120 (60) 103 (52) 0.44 Death 16 (8) 21 (11) 0.70 Safety Any adverse event (AE) 141 (71) 145 (74) 0.86 Grade ≥3 study drug-related AE 8 (4) 10 (5) 0.65 Study drug-related serious adverse 3 (2) 4 (2) 0.73 event (SAE) AE leading to discontinuation 9 (5) 20 (10) 0.07
^1Adjusted for baseline clinical status
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. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10, administered intravenously, in addition to standard of care. An expansion phase of the study was recently added and will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
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.
Caffeine 发表于 2020-04-29 08:47
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery. 用药10天的治愈率更低？！是否说明药的作用是反的？ 个人仍然持强烈怀疑态度，等NIH实验的结果，从这个实验结果看不出药有用。
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery. 用药10天的治愈率更低？！是否说明药的作用是反的？ 个人仍然持强烈怀疑态度，等NIH实验的结果，从这个实验结果看不出药有用。 nyc15 发表于 4/29/2020 8:58:00 AM
两个巨大的red flag，第一是没有对照组，第二是这一句话：At Day 14, 64.5 percent (n=129/200) of patients in the5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-daytreatment group achieved clinical recovery.用药10天的治愈率更低？！是否说明药的作用是反的？个人仍然持强烈怀疑态度，等NIH实验的结果，从这个实验结果看不出药有用。 nyc15 发表于 4/29/2020 8:58:13 AM
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery.
quick note from an analyst: "This is earlier than expected Most important study we are aware of. Has a placebo. This is the trial run by the govt – NOT the GILD trial we were expecting results out today or tomorrow. This was NOT just in severe patients. This is MODERATE and severe It hit the primary endpoint which means it hit the efficacy end point which for dummies means it works. " Caffeine 发表于 4/29/2020 8:48:37 AM
建议加上今早Dr. Scott Gottlieb 在CNBC的采访，他说话一直非常谨慎。
As we've been saying for some time now, accumulating data on Remdesivir suggests it's active against covid and there's now enough data to support consideration of access under an emergency use authorization by FDA. The data from NIAID study should push this firmly over the line.
Gilead’s remdesivir, along with therapeutic antibodies and improved testing, is part of “a robust toolbox,” Dr. Scott Gottlieb says. “All of this is going to put us in a much different posture for the fall.” https://cnb.cx/2SgbRfu
两个巨大的red flag，第一是没有对照组，第二是这一句话：At Day 14, 64.5 percent (n=129/200) of patients in the5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-daytreatment group achieved clinical recovery.用药10天的治愈率更低？！是否说明药的作用是反的？个人仍然持强烈怀疑态度，等NIH实验的结果，从这个实验结果看不出药有用。 nyc15 发表于 4/29/2020 8:58:13 AM
划重点: 没有control group。 看得懂英文的好好读读 The main concern, they say, stems from the fact that the Gilead trial expected to read out this week, which was conducted among patients with severe disease, lacks a control group — that is, patients who are randomly assigned to receive the best treatment available, but not remdesivir. As designed, the only randomization is the duration of treatment: either five days or 10 days of drug. Without a true control group of patients, many experts say, it will be difficult to determine whether remdesivir is effective. “The overall study itself has little or no scientific value since all patients are receiving the drug,” said Steven Nissen, the chief academic officer at the Cleveland Clinic and lead investigator of many trials for heart drugs that have been approved by the Food and Drug Administration. “The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.” “For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach said.
The main concern, they say, stems from the fact that the Gilead trial expected to read out this week, which was conducted among patients with severe disease, lacks a control group — that is, patients who are randomly assigned to receive the best treatment available, but not remdesivir. As designed, the only randomization is the duration of treatment: either five days or 10 days of drug. Without a true control group of patients, many experts say, it will be difficult to determine whether remdesivir is effective.
“The overall study itself has little or no scientific value since all patients are receiving the drug,” said Steven Nissen, the chief academic officer at the Cleveland Clinic and lead investigator of many trials for heart drugs that have been approved by the Food and Drug Administration.
“The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said.
Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.”
“For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach said. cannie 发表于 4/29/2020 9:34:27 AM
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery.
quick note from an analyst: "This is earlier than expected Most important study we are aware of. Has a placebo. This is the trial run by the govt – NOT the GILD trial we were expecting results out today or tomorrow. This was NOT just in severe patients. This is MODERATE and severe It hit the primary endpoint which means it hit the efficacy end point which for dummies means it works. " Caffeine 发表于 4/29/2020 8:48:37 AM
"The overall mortality rates in the five-day and 10-day groups were 8.0% (n=16/200) and 10.7% (n=21/197), respectively." 这个? atomicmass 发表于 2020-04-29 10:12
"The overall mortality rates in the five-day and 10-day groups were 8.0% (n=16/200) and 10.7% (n=21/197), respectively." 这个? atomicmass 发表于 4/29/2020 10:12:51 AM
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery.
The main concern, they say, stems from the fact that the Gilead trial expected to read out this week, which was conducted among patients with severe disease, lacks a control group — that is, patients who are randomly assigned to receive the best treatment available, but not remdesivir. As designed, the only randomization is the duration of treatment: either five days or 10 days of drug. Without a true control group of patients, many experts say, it will be difficult to determine whether remdesivir is effective.
“The overall study itself has little or no scientific value since all patients are receiving the drug,” said Steven Nissen, the chief academic officer at the Cleveland Clinic and lead investigator of many trials for heart drugs that have been approved by the Food and Drug Administration.
“The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said.
Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.”
“For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach said. cannie 发表于 4/29/2020 9:34:27 AM
建议加上今早Dr. Scott Gottlieb 在CNBC的采访，他说话一直非常谨慎。 As we've been saying for some time now, accumulating data on Remdesivir suggests it's active against covid and there's now enough data to support consideration of access under an emergency use authorization by FDA. The data from NIAID study should push this firmly over the line. Gilead’s remdesivir, along with therapeutic antibodies and improved testing, is part of “a robust toolbox,” Dr. Scott Gottlieb says. “All of this is going to put us in a much different posture for the fall.” https://cnb.cx/2SgbRfuhttps://twitter.com/ScottGottliebMD/status/1255484418745151495?s=20 fufusix 发表于 4/29/2020 9:19:00 AM
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery.
两个巨大的red flag，第一是没有对照组，第二是这一句话：At Day 14, 64.5 percent (n=129/200) of patients in the5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-daytreatment group achieved clinical recovery.用药10天的治愈率更低？！是否说明药的作用是反的？个人仍然持强烈怀疑态度，等NIH实验的结果，从这个实验结果看不出药有用。 nyc15 发表于 4/29/2020 8:58:13 AM
Edit
1. Fauci statements below. and CNBC video here: https://twitter.com/nbcnews/status/1255541788154224641?s=21
- NYT: FDA to announce Emergency Use of remdesivir as early as Wednesday
2. 北京这次怎么这么恶心啊。刚出了好消息，然后就把在中国的“failed" study 结果贴在了lancet上。你们这些人，做事要有点良心。一次次刷底线，要脸么？
3. 这个帖子一下子看出来需要屏蔽的id是什么。
两个Gilead自己的发布：
1. 第一个。这个是美国政府的双盲。
Gilead Sciences Statement on Positive Data Emerging From National Institute
of Allergy and Infectious Diseases’ Study of Investigational Antiviral
Remdesivir for COVID-19
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences. Inc. (Nasdaq: GILD) is aware of positive data emerging from
the National Institute of Allergy and Infectious Diseases’ (NIAID) study of
the investigational antiviral remdesivir for the treatment of COVID-19. We
understand that the trial has met its primary endpoint and that NIAID will
provide detailed information at an upcoming briefing.
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.
Gilead will share additional remdesivir data from the company’s open-label
Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. This
study will provide information on whether a shorter, 5-day duration of therapy
may have similar efficacy and safety as the 10-day treatment course evaluated
in the NIAID trial and other ongoing trials. Gilead expects data at the end of
May from the second SIMPLE study evaluating the 5- and 10-day dosing durations
of remdesivir in patients with moderate COVID-19 disease.
Gilead will continue to discuss with regulatory authorities the growing data
set regarding remdesivir as a potential treatment for COVID-19.
2.randomized trial
Gilead Announces Results From Phase 3 Trial of Investigational Antiviral
Remdesivir in Patients With Severe COVID-19
-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of
Remdesivir --
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences, Inc. (Nasdaq: GILD) 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
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 drug development, we are attempting to evaluate an
investigational agent alongside an evolving global pandemic. Multiple
concurrent studies are helping inform whether remdesivir is a safe and
effective treatment for COVID-19 and how to best utilize the drug,” said
Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study
results complement data from the placebo-controlled study of remdesivir
conducted by the National Institute for Allergy and Infectious Diseases and
help to determine the optimal duration of treatment with remdesivir. The study
demonstrates the potential for some patients to be treated with a 5-day
regimen, which could significantly expand the number of patients who could be
treated with our current supply of remdesivir. 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. This
study sought to determine whether a shorter, 5-day course of remdesivir would
achieve similar efficacy results as the 10-day treatment regimen used in
multiple ongoing studies of remdesivir. Secondary objectives included rates of
adverse events and additional measures of clinical response in both treatment
groups. Patients were required to have evidence of pneumonia and reduced
oxygen levels that did not require mechanical ventilation at the time of study
entry. 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 this study, the time to clinical improvement for 50 percent of patients was
10 days in the 5-day treatment group and 11 days in the 10-day treatment
group. 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 patients in the 10-day
treatment group achieved clinical recovery.
Clinical outcomes varied by geography. Outside of Italy, the overall mortality
rate at Day 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 10 days of symptoms. 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 clinical improvement
as patients who received a 10-day treatment course,” said Aruna Subramanian,
MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious
Diseases, Stanford University School of Medicine, and one of the lead
investigators of the study. “While additional data are still needed, these
results help to bring a clearer understanding of how treatment with remdesivir
may be optimized, if proven safe and effective.”
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment
groups. The most common adverse events occurring in more than 10 percent of
patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%,
n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day:
10.7%, n= 21/197). 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.
Key efficacy and safety results from the study are included in the table
below.
5-Day RDV 10-Day RDV Baseline adjusted
n=200 n=197 p-value^1
Clinical Efficacy Outcomes at Day 14
≥ 2-point improvement in ordinal scale 129 (65) 107 (54) 0.16
Clinical recovery 129 (65) 106 (54) 0.17
Discharge 120 (60) 103 (52) 0.44
Death 16 (8) 21 (11) 0.70
Safety
Any adverse event (AE) 141 (71) 145 (74) 0.86
Grade ≥3 study drug-related AE 8 (4) 10 (5) 0.65
Study drug-related serious adverse 3 (2) 4 (2) 0.73
event (SAE)
AE leading to discontinuation 9 (5) 20 (10) 0.07
^1Adjusted for baseline clinical status
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. The initial phase of the study randomized 397
patients in a 1:1 ratio to receive remdesivir 200 mg on the first day,
followed by remdesivir 100 mg each day until day 5 or 10, administered
intravenously, in addition to standard of care. An expansion phase of the
study was recently added and will enroll an additional 5,600 patients,
including patients on mechanical ventilation. The study is being conducted at
180 trial sites around the world, including sites in the United States, China,
France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore,
Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
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.
🔥 最新回帖
大青椒怎么跟你们说的，看看GILD股价，错了吗？今天CODX可是涨了16%！
川粉义和团们估计也买不起什么股票吧？不必操这份闲心。
讲真，如果副作用只是心律不齐那不要太好了。。。
目前除了这个双盲其他基本都只有同情用药，大家之所以盼着这个临床数据就是想早点知道这个药到底能不能批。两个月1000多的临床实验这个速度已经很快了。说到没有任何一个国家肯定效果，不知道中国援助意大利的时候带的山寨版算不算肯定效果，到底是想拿意大利弟兄当小白鼠呢还是真心想提供帮助。。。。
這像是聽曹彬說的，一個人身高 1.75，一個人1.749。。。
到底事實是這樣嗎，人們要知道真相。
上網看一看就知道，曹彬一人中國一國在用一個被他們中止的實驗和全世界的專家們爭辯中，除了 Stupid 真不知說他們什麼好了。
🛋️ 沙发板凳
两个巨大的red flag，第一是没有对照组，第二是这一句话：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 patients in the 10-day treatment group achieved clinical recovery.
用药10天的治愈率更低？！是否说明药的作用是反的？
个人仍然持强烈怀疑态度，等NIH实验的结果，从这个实验结果看不出药有用。
这种带节奏的屏蔽就好了：）
奇了怪了，是药三分毒没听过？能吃5天治好干嘛非要吃10天，完全没毛病。抗生素不也是有规定用药周期么
因为我对药和疫苗都很不看好，RNA病毒、ADE效应、大量二次感染和常阳患者的报告，这个冠状病毒哪那么容易被克服。不知道你们这些人的乐观态度都是哪里来的。。。
别装了，你是对美国所有东西不看好
没有对照组，研究个屁啊？！
这是有机构在炒作这只股票而已。
一针见血
我对厉害国在试验的三个疫苗更不看好，谢谢。不知道为什么总有人给我扣五毛的帽子。
厉害国的实验疫苗两个是灭活病毒，对免疫系统的刺激不够，说不定引发ADE死的更快；另一个腺病毒载体用的病毒在人群中太常见，大多数人对那个载体病毒已经有抗体，疫苗一打进去就被人体自己的免疫系统灭了。
因为你就是五毛。
建议加上今早Dr. Scott Gottlieb 在CNBC的采访，他说话一直非常谨慎。
As we've been saying for some time now, accumulating data on Remdesivir suggests it's active against covid and there's now enough data to support consideration of access under an emergency use authorization by FDA. The data from NIAID study should push this firmly over the line.
Gilead’s remdesivir, along with therapeutic antibodies and improved testing, is part of “a robust toolbox,” Dr. Scott Gottlieb says. “All of this is going to put us in a much different posture for the fall.” https://cnb.cx/2SgbRfu
https://twitter.com/ScottGottliebMD/status/1255484418745151495?s=20
当然有对照。你没看试验设计吗？对照是“standard of care"
还有那个无底线维护WHO的盖子。今早看到他的一个采访，当记者问到疫情对美国经济和社会的灾难性影响，他都抑制不住得意的笑出声，起鸡皮疙瘩。
人类研究药本来就不是指哪儿打哪儿
伟哥一开始好像是准备治心脏病啥的
没有 Control group ，研究个屁啊。华尔街有人要拉垫背的。
抬头看ID系列
一针见黑血
无毛一只，早屏蔽了
咋屏蔽呢？能教一下吗？谢谢！
看着几个五毛发疯的样子，偷偷乐一下。 谢谢咖啡因，一大早带来这么好的消息。 顺便鄙视一下ccp对gilead各种使坏，太没人性。
这些五毛，要么看不懂英文，要么装瞎。非蠢即坏。 看他们跳，一边觉得他们真是可悲，一边又觉得好好笑。
线性外推的话就是说不用药的死亡率是5.4%
这是重症的。这个出了数据的trial是只收重症的。 用20%重症率来算， 那么人民的希望推广后死亡率是20%*8%=1.6%。 这还是假设轻症不用药的情况。 轻症目前看药效其实更好。那么如果轻症用药可以降低重症率，死亡率还会更低。弄不好降到1%以下都有可能。 嘻嘻。
This is for those hospitalized (住院的, 不一定插管的). I still feel this fatality rate is kind of high for those hospitalized.
原话："in hospitalized patients with severe manifestations of COVID-19 disease"
这个死亡率真心不高。一般重症死亡率在15%以上。 就以中国那个被人质疑粉饰太平的overall 3.5%的死亡率来算， 如果以重症率20%估计，那么重症死亡率是3.5%/20%=17.5%，是这个数据的一倍。
合理的质疑问值得鼓励。但是你从来没有详细说明你一贯怀疑的理由，对不对？
我是从Gilead半路上扩大实验规模和改变评价标准的时候开始怀疑的，内行都知道这意味着什么。。。在这以前我也错误地认为瑞德西韦是特效药。
你要仔细看报告，进入试验的一个要求是开始给药的时候还没有上呼吸机！所以这根本不是最严重病人的数据，真正严重的病人还没来得及进医院就爆发性呼吸衰竭憋死在家里了。
上呼吸机的，80%的死亡率。。。。你要干啥？？ 不把80%的死亡率降到1%以下，就算没用？
我说你看了药有用这么伤心，到底是有任务，还是short gilead股票亏钱了?
这个逻辑很奇特，哪一种药是专治垂死的病人？如果有就是起死回生的仙丹。你的思维非常出格，也许细节上有点道理，却在整体上没有常识。
是啊，我印象深刻的也是美国疫情刚开始爆发时，他上CNN，和AC以及Gupta 医生聊这次的新冠。其他两人都是表情严肃，只有他全程笑眯眯的。也许他的表情历来如此？ 反正看着非常不舒服……
NIN的是双盲的吧。这个randomized的实验感觉只是不想浪费数据，既然有患者在用药，那就统计统计，起码得出用药5天和10天治疗效果无差别的结果，也没打算用这个试验的结果去跟FDA申请吧
我觉得出数据的那个没有对照组的trial，主要目的是为了找出最优的用药方法。NIH那个才是真的要用来批准药的。虽然NIH具体数据还没有公布，但基本有效的结论已经出来了。估计FDA批准也快了。
跟华尔街联合了？ 生物统计，如果不严谨，什么结论都能造出来的。
这名字又不是美国人起的。
就因为是国内人取的，所以七毛更紧张啊，哪能让外国药成为人民的希望，人民的希望只能是习大大
“人民的希望” 是中國疫情最嚴重時，國人給起的名字。疫情過去了，不用了，又被五毛煽動的反對起來了？中國的疫情是否真過去了還不好說吧？
還是大家一起支持這藥，瑞德西韋搞成功了，世界的哪個國家都受惠。
我现在怀疑这药只对很少的一部分人有用，而我们不知道是哪一部分。
还在trial中。FDA还没批准。再等几周。我记得是五月中？
第一个新闻就是关于这个的。今天大家激动，就是因为这个提前有了efficacy reading.
5天和10天的病人不是随机分布的啊， 10天的病人本来就更重。 NIH随机双盲的详细结果说了NIH稍后会公布。
重症trial招不到placebo对照组的，不 ethical, 让人家等死吗？，轻症trial有对照组。
tg一直不都这样吗，过河拆桥，忘恩负义
新药上市前7年最好不要吃
是这样的。这个药有效是无疑问的，虽然特效药算不上，但是目前备选里面表现最robust的。
早就不抱希望了，但是药厂投入巨大，需要拉盘把股票逃出来，弥补损失。小散慎入！
啥时候说的，今天吗？
Just now. His statements are updated on 1fl.
通过点踩的数量大概知道驻版大伍毛数，再加几个新注册的小无毛，大约10个左右驻版伍毛吧
Remdesivir 的奇幻之旅，可能只因被 naive 的群众起名为 “人民的希望”
难道五毛良心都被狗吃了吗？药能救人不好吗？
毒就是他们放的，有解药的话他们这几个月不就白忙活了
这两个单抗最近都有trial结果发表了啊，regeneron的结果不是很理想，托珠单抗的结果还不错
啦啦啦啦啦啦啦啦啦。 哈哈哈哈。 看五毛如丧考妣，简直太开心了。