The National Institutes of Health said Saturday that it had stopped two clinical trials of hydroxychloroquine, the malaria drug that President Trump promoted to treat and prevent the coronavirus, one because the drug was unlikely to be effective and the other because not enough patients signed up to participate.
The agency halted a trial that had aimed to enroll more than 500 patients after an independent oversight board determined that the drug did not appear to benefit hospitalized patients. The same day, the N.I.H. said it had closed another trial — of hydroxychloroquine and the antibiotic azithromycin — because only about 20 patients had enrolled in the planned study of 2,000 people.
The two trials the N.I.H. shut down represent the latest evidence that hydroxychloroquine has not lived up to its early promise of fighting the coronavirus.
The N.I.H. said Saturday that an independent oversight board that monitors safety met late Friday to discuss the 500-patient trial and “determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with Covid-19,” the disease caused by the virus.
“In effect, the drug didn’t work,” said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center who was not involved in the research. “I think we can put this drug aside and now devote our attention to other potential treatments.”
Mr. Trump had called the drug a “game changer” and took it himself in hopes of protecting himself from infection with the coronavirus. Drugmakers donated millions of doses to the federal stockpile, which distributed them to hospitals around the country, where doctors with few other options administered the drug to severely ill patients.
On Monday, the Food and Drug Administration revoked the emergency authorization it had granted to hospitals to give hydroxychloroquine and a related drug, chloroquine, to patients. The agency said that the drugs were unlikely to be effective and could carry potential risks.
While the N.I.H. said it did not identify safety concerns as part of its review of the 500-patient trial, others have concluded that hydroxychloroquine carries potential risks. This spring, the F.D.A. issued a warning that the drugs could cause dangerous heart arrhythmias in Covid-19 patients.
The planned trial, which was being run by the National Heart, Lung, and Blood Institute, a division of the N.I.H., had enrolled more than 470 patients when the study was stopped. The study sought to learn whether the drug benefited hospitalized patients and those who visited the emergency room, as well as people who were likely to be admitted to the hospital. It was one of several placebo-controlled studies that had been organized to test the drug after a series of small, poorly controlled trials showed early signs of a benefit.
The other trial that was halted, involving hydroxychloroquine and azithromycin, was testing whether the drugs, given together earlier in the disease, could prevent hospitalization and death from Covid-19. That study, led by the National Institute of Allergy and Infectious Diseases, an arm of the N.I.H., “sought to fill this knowledge gap by testing it in a randomized, placebo-controlled trial — considered the gold standard for determining whether an intervention can benefit patients,” the agency said in a statement.
The agency said it did not find any safety problems, but concluded that the recent decision by the F.D.A. to revoke its emergency authorization of hydroxychloroquine “could further dampen enthusiasm for enrollment in studies evaluating these drugs.”
Several other large trials of hydroxychloroquine have been stopped or have not shown the drug to be effective.
“No surprise,” said Dr. David R. Boulware, an infectious disease specialist at the University of Minnesota, who is studying hydroxychloroquine as a preventive and an early treatment against the coronavirus. He said the evidence is increasingly clear that the drug does not work in hospitalized patients. “Whether there is any benefit for pre-exposure prophylaxis or early treatment is as yet unknown, but the role of hydroxychloroquine — if any — appears increasingly doubtful.”
On Wednesday, the World Health Organization said it was stopping the hydroxychloroquine arm of a large clinical trial that is testing several treatments against the virus because evidence — including results from a large study in the United Kingdom — showed it did not reduce mortality rates of hospitalized patients.
-
Updated June 16, 2020
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Will protests set off a second viral wave of coronavirus?
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
-
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.
-
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.
-
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.)
-
Should I wear a mask?
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
-
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.
And on Friday, the Swiss drugmaker Novartis said it was halting its clinical trial because it could not recruit enough patients to sign up. Only a handful enrolled even though the company had planned for a study involving 440 people.
Other researchers are still studying whether hydroxychloroquine could be used earlier in the course of the illness, or to prevent people from getting infected from the virus. While some of those studies are still underway, one such trial — led by Dr. Boulware — concluded earlier this month that hydroxychloroquine was not effective in preventing infections after someone had been exposed.
That trial included 821 people and looked at whether those who were exposed to the virus, such as health care workers or family members of people who had been infected, were less or more likely to be infected themselves if they were given the drug. It found that there was not a meaningful difference.
