The American biopharmaceutical company Gilead Sciences will soon start trials of an inhalable version of remdesivir, an antiviral drug that has shown promise as a therapeutic against the coronavirus in early trials, according to a statement released Monday.
Remdesivir is currently given intravenously, which restricts its use to hospital settings. “That’s been the limitation” with this drug, said Dr. Mangala Narasimhan, a pulmonologist and regional director of critical care medicine at Northwell Health.
Gilead’s inhalable version of the treatment would be administered through a nebulizer, a device that sends a mist of therapeutic liquid into the airway and is often used by asthma patients. Some nebulizers are portable; Gilead scientists hope that a more convenient treatment would be used by patients at various stages of infection.
Nebulizers “are commonly available” compared with IV equipment, said Angela Rasmussen, a virologist at Columbia University. “Pretty much every outpatient urgent care clinic has them. You could potentially treat somebody on the spot who has a positive test” for the coronavirus “but may or may not have symptoms.”
Remdesivir, which interferes with virus replication, is the first antiviral drug to show effectiveness against the coronavirus in human trials. It was given Emergency Use Authorization by the United States Food and Drug Administration on May 1, allowing physicians to deploy the drug intravenously in hospitalized patients with confirmed diagnoses of Covid-19, the disease caused by the coronavirus. However, this designation does not constitute formal drug approval, and remdesivir’s safety and efficacy are still being investigated in several clinical trials.
In a study published in May in the New England Journal of Medicine, remdesivir showed modest effects, shortening average recovery time to 11 days from 15 in hospitalized patients with the coronavirus. But the effects on mortality were negligible.
Buoyed by these early results, Gilead Sciences now hopes their inhalable iteration of remdesivir will help “stem the tide of the pandemic,” Daniel O’Day, Gilead’s chairman and C.E.O., said in a statement Monday. Beginning this week, healthy volunteers will be screened for participation in Phase I trials, which will test for safety. Covid-19 patients are expected to enter the lineup as early as August.
Convenience could end up being crucial to boosting remdesivir’s effects, Dr. Rasmussen said. The drug may be less effective when administered late in infection, after a patient has already sought treatment for serious symptoms. But under ideal circumstances, early doses of remdesivir could nip the disease in the bud.
Antivirals are generally thought to be most effective early in infection, before a pathogen can gain a strong foothold in the body and drive some of the most severe and life-threatening aspects of disease. The immune response to the coronavirus can be overzealous, at first rousing itself to clear an infectious invader, before spilling over and destroying healthy tissue in a misguided bid to protect the body. “If you could get rid of the virus before they develop those disease symptoms, you would probably have better clinical outcomes across many patients,” Dr. Rasmussen said.
Still, there is no guarantee that inhaled remdesivir will be an improvement over its injectable form, or even that it will be up to par. Dr. Narasimhan noted that it will be crucial to monitor how well, and how quickly, the drug is absorbed by the parts of the body that need it most. Trials will most likely require researchers to tinker with factors like dose, especially in patients with damaged lungs.
Generally speaking, nebulizers are “well-tolerated” by patients, including those with chronic respiratory conditions like asthma, Dr. Narasimhan said. But they can irritate some people’s airways, or make patients cough. Many physicians have been avoiding the devices out of concern that they could spread viral particles exiting the airways of infected patients into surrounding air, she added.
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Updated June 22, 2020
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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.
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I’ve heard about a treatment called dexamethasone. Does it work?
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.
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What is pandemic paid leave?
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.
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Does asymptomatic transmission of Covid-19 happen?
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.
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What’s the risk of catching coronavirus from a surface?
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.
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How does blood type influence coronavirus?
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.
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How many people have lost their jobs due to coronavirus in the U.S.?
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.
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My state is reopening. Is it safe to go out?
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
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What are the symptoms of coronavirus?
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.
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How can I protect myself while flying?
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.)
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What should I do if I feel sick?
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.
“It brings up a lot of issues,” Dr. Narasimhan said. “Can we use this safely? In what setting? Do we need to do this in isolation? We’d have to figure out a way to do it safely.”
Dr. Louis DePalo, a pulmonologist at Mount Sinai’s Icahn School of Medicine, noted that inhaled remdesivir therapies are “a worthy goal, but fraught with issues.” Prior treatments that have attempted the inhalation route, including a few delivering gene therapy or insulin, have failed before. Remdesivir can also be toxic if dosed improperly.
In the statement, Gilead also announced plans to manufacture two million more treatment courses of remdesivir by year’s end. The company also hopes to combine the antiviral with other drugs that can modulate the immune system, which, in later stages of infection, appears to be responsible for many of Covid-19’s ill effects. Among this group of immunity-targeting treatment are steroids like dexamethasone, which reportedly reduced deaths among a group of patients suffering from severe Covid-19.
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