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Federal Scientists Finally Publish Remdesivir Data Federal Scientists Finally Publish Remdesivir Data
(2 days later)
Nearly a month after federal scientists claimed that an experimental drug had helped patients severely ill with the coronavirus, the research has been published.Nearly a month after federal scientists claimed that an experimental drug had helped patients severely ill with the coronavirus, the research has been published.
The drug, remdesivir, was quickly authorized by the Food and Drug Administration for treatment of coronavirus patients, and hospitals rushed to obtain supplies.The drug, remdesivir, was quickly authorized by the Food and Drug Administration for treatment of coronavirus patients, and hospitals rushed to obtain supplies.
But until now, researchers and physicians had not seen the actual data. And remdesivir, made by Gilead Sciences, has a spotty history. It was originally intended to treat hepatitis, but it failed to. It was tested against Ebola, but results were lackluster.But until now, researchers and physicians had not seen the actual data. And remdesivir, made by Gilead Sciences, has a spotty history. It was originally intended to treat hepatitis, but it failed to. It was tested against Ebola, but results were lackluster.
So far, remdesivir has not been officially approved for any purpose. The F.D.A.’s emergency use authorization was not a formal approval.So far, remdesivir has not been officially approved for any purpose. The F.D.A.’s emergency use authorization was not a formal approval.
The long-awaited study, sponsored by the National Institute of Allergy and Infectious Diseases, appeared on The New England Journal of Medicine website on Friday evening. It confirms the essence of the government’s assertions: Remdesivir shortened recovery time from 15 days to 11 days in hospitalized patients. The study defined recovery as “either discharge from the hospital or hospitalization.”The long-awaited study, sponsored by the National Institute of Allergy and Infectious Diseases, appeared on The New England Journal of Medicine website on Friday evening. It confirms the essence of the government’s assertions: Remdesivir shortened recovery time from 15 days to 11 days in hospitalized patients. The study defined recovery as “either discharge from the hospital or hospitalization.”
The trial was rigorous, randomly assigning 1,063 seriously ill patients to receive either remdesivir or a placebo. Those who received the drug not only recovered faster but also did not have serious adverse events more often than those who were given the placebo.The trial was rigorous, randomly assigning 1,063 seriously ill patients to receive either remdesivir or a placebo. Those who received the drug not only recovered faster but also did not have serious adverse events more often than those who were given the placebo.
It was an international trial, although most sites were in the United States. Patients were assessed daily, and those administering the evaluations did not know whether a patient had been given remdesivir or the placebo.It was an international trial, although most sites were in the United States. Patients were assessed daily, and those administering the evaluations did not know whether a patient had been given remdesivir or the placebo.
A monitoring board reviewed the data at specified intervals and called for a halt to the study when there was clear evidence that the drug was effective.A monitoring board reviewed the data at specified intervals and called for a halt to the study when there was clear evidence that the drug was effective.
On April 29, N.I.A.I.D. issued a news release stating as much. But infectious disease doctors were frustrated, because they did not have access to the findings, which might have affected how patients were treated.On April 29, N.I.A.I.D. issued a news release stating as much. But infectious disease doctors were frustrated, because they did not have access to the findings, which might have affected how patients were treated.
“For God’s sake, this is a pandemic — we need some data,” said Dr. Judith Feinberg, vice chair of research at West Virginia University School of Medicine.“For God’s sake, this is a pandemic — we need some data,” said Dr. Judith Feinberg, vice chair of research at West Virginia University School of Medicine.
Publication of the paper has brought some relief. Doctors had been wondering, for instance, whether they should give remdesivir to patients with the most serious Covid-19 cases or to those who weren’t as sick, especially if there were not enough to go around.Publication of the paper has brought some relief. Doctors had been wondering, for instance, whether they should give remdesivir to patients with the most serious Covid-19 cases or to those who weren’t as sick, especially if there were not enough to go around.
Dr. Andre Kalil of the University of Nebraska, a principal investigator of the study, noted that not only do sicker patients fare as well on remdesivir, but their average time to recovery is also slightly faster.Dr. Andre Kalil of the University of Nebraska, a principal investigator of the study, noted that not only do sicker patients fare as well on remdesivir, but their average time to recovery is also slightly faster.
He added that Hispanics, black people and white patients all derived equal benefit from the drug, as did men and women as well as adults in every age group.He added that Hispanics, black people and white patients all derived equal benefit from the drug, as did men and women as well as adults in every age group.
Updated June 30, 2020
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
The results were the same for patients regardless of whether they had received the drug treatment before or after 10 days of symptoms, said Dr. Helen Chu, of the University of Washington, who was also an investigator of the study.The results were the same for patients regardless of whether they had received the drug treatment before or after 10 days of symptoms, said Dr. Helen Chu, of the University of Washington, who was also an investigator of the study.
The study’s designers changed the outcome measures after the study had began, but they did not have access to the current data. Some critics questioned whether the change had altered the study’s conclusions, but a subsequent analysis determined that it did not.The study’s designers changed the outcome measures after the study had began, but they did not have access to the current data. Some critics questioned whether the change had altered the study’s conclusions, but a subsequent analysis determined that it did not.
The disease had a more protracted course than the investigators had realized, federal officials said, and the original endpoints — the measures of success — were unworkable.The disease had a more protracted course than the investigators had realized, federal officials said, and the original endpoints — the measures of success — were unworkable.
The best outcome would have been a decline in the death rate among patients given remdesivir, but there were only hints that this had occurred.The best outcome would have been a decline in the death rate among patients given remdesivir, but there were only hints that this had occurred.
Despite generally positive results, the researchers caution that the drug is far from ideal.Despite generally positive results, the researchers caution that the drug is far from ideal.
“Given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” they concluded.“Given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” they concluded.