声明：我不是托。没有和这个股票的任河关系。我的401k共同基金可能有。
Edit
1. Fauci statements below. and CNBC video here: [url=https://rd2.huaren.us/huaren.php?hrtopic_id=2541213&hrurl=https%3a%2f%2ftwitter.com%2fnbcnews%2fstatus%2f1255541788154224641%3fs%3d21]https://twitter.com/nbcnews/status/1255541788154224641?s=21[/url]
- 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.
Edit
1. Fauci statements below. and CNBC video here: [url=https://rd2.huaren.us/huaren.php?hrtopic_id=2541213&hrurl=https%3a%2f%2ftwitter.com%2fnbcnews%2fstatus%2f1255541788154224641%3fs%3d21]https://twitter.com/nbcnews/status/1255541788154224641?s=21[/url]
- 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.
