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Malaria Drug Promoted by Trump Did Not Prevent Covid Infections, Study Finds Malaria Drug Promoted by Trump Did Not Prevent Covid Infections, Study Finds
(32 minutes later)
The malaria drug hydroxychloroquine did not prevent Covid-19 in a rigorous study of 821 people who had been exposed to patients infected with the virus, researchers from the University of Minnesota and Canada are reporting on Wednesday.The malaria drug hydroxychloroquine did not prevent Covid-19 in a rigorous study of 821 people who had been exposed to patients infected with the virus, researchers from the University of Minnesota and Canada are reporting on Wednesday.
The study was the first controlled clinical trial of hydroxychloroquine, a drug that President Trump has repeatedly promoted and recently taken himself. Conducted in the United States and Canada, this trial was the first to test whether the drug could prevent illness in people who have been exposed to the coronavirus. This type of study, in which patients are picked at random to receive either an experimental treatment or a placebo, is considered the most reliable way to measure the safety and effectiveness of a drug. The participants were health care workers and people who had been exposed at home to ill spouses, partners or parents.The study was the first controlled clinical trial of hydroxychloroquine, a drug that President Trump has repeatedly promoted and recently taken himself. Conducted in the United States and Canada, this trial was the first to test whether the drug could prevent illness in people who have been exposed to the coronavirus. This type of study, in which patients are picked at random to receive either an experimental treatment or a placebo, is considered the most reliable way to measure the safety and effectiveness of a drug. The participants were health care workers and people who had been exposed at home to ill spouses, partners or parents.
“The take-home message for the general public is that if you’re exposed to someone with Covid-19, hydroxychloroquine is not an effective post-exposure, preventive therapy,” the lead author of the study, Dr. David R. Boulware, from the University of Minnesota, said in an interview.“The take-home message for the general public is that if you’re exposed to someone with Covid-19, hydroxychloroquine is not an effective post-exposure, preventive therapy,” the lead author of the study, Dr. David R. Boulware, from the University of Minnesota, said in an interview.
The results are being published in The New England Journal of Medicine. The results are published in The New England Journal of Medicine.
“If we could find something that would ameliorate infection, block it or make it milder after a solid exposure, that would be quite wonderful,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University. “What we want to do is limit the number of cases. There was great hope riding on this.”“If we could find something that would ameliorate infection, block it or make it milder after a solid exposure, that would be quite wonderful,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University. “What we want to do is limit the number of cases. There was great hope riding on this.”
The president’s promotion of the drug, and the backlash against it, have politicized medical questions that would normally have been left to researchers to answer objectively. Trump supporters and opponents have accused one another of twisting facts about the drug to make the president look either right, or wrong.The president’s promotion of the drug, and the backlash against it, have politicized medical questions that would normally have been left to researchers to answer objectively. Trump supporters and opponents have accused one another of twisting facts about the drug to make the president look either right, or wrong.
But Mr. Trump has not stopped touting the drug’s potential benefits. On Sunday, his administration announced that it was sending 2 million doses of the drug to Brazil, to treat patients and help prevent infection in health care workers. A White House official said the two countries would collaborate on research into its use.But Mr. Trump has not stopped touting the drug’s potential benefits. On Sunday, his administration announced that it was sending 2 million doses of the drug to Brazil, to treat patients and help prevent infection in health care workers. A White House official said the two countries would collaborate on research into its use.
Early in the pandemic, the drug's use was spurred by anecdotal reports from China and France of patients who seemed to improve and laboratory findings of a possible antiviral effect. With no proven treatment for Covid-19, doctors have been desperate to give severely ill patients some kind of therapy.Early in the pandemic, the drug's use was spurred by anecdotal reports from China and France of patients who seemed to improve and laboratory findings of a possible antiviral effect. With no proven treatment for Covid-19, doctors have been desperate to give severely ill patients some kind of therapy.
Data from more recent studies have been called into question in the last week, furthering debates over the drug’s role in trials around the world. On Wednesday, the World Health Organization said it would resume trials it had temporarily suspended over the issues raised about data used in a study in the Lancet.Data from more recent studies have been called into question in the last week, furthering debates over the drug’s role in trials around the world. On Wednesday, the World Health Organization said it would resume trials it had temporarily suspended over the issues raised about data used in a study in the Lancet.
Interest in the drug surged after Mr. Trump began advocating it. It is approved to treat rheumatoid arthritis and lupus, as well as malaria, and is considered safe for those patients as long as they do not have underlying abnormalities in their heart rhythm.Interest in the drug surged after Mr. Trump began advocating it. It is approved to treat rheumatoid arthritis and lupus, as well as malaria, and is considered safe for those patients as long as they do not have underlying abnormalities in their heart rhythm.
Studies in very ill coronavirus patients have linked the drug — especially when combined with the antibiotic azithromycin — to dangerous heart-rhythm disorders, and both the Food and Drug Administration and the National Institute of Allergy and Infectious Diseases have warned that it should not be used outside of clinical trials or carefully monitored conditions in a hospital.Studies in very ill coronavirus patients have linked the drug — especially when combined with the antibiotic azithromycin — to dangerous heart-rhythm disorders, and both the Food and Drug Administration and the National Institute of Allergy and Infectious Diseases have warned that it should not be used outside of clinical trials or carefully monitored conditions in a hospital.
Some researchers say that safety concerns about the drug have been overblown, alarming the public and making it difficult to recruit participants for the studies needed to determine whether the drug has any value for treatment or prevention.Some researchers say that safety concerns about the drug have been overblown, alarming the public and making it difficult to recruit participants for the studies needed to determine whether the drug has any value for treatment or prevention.
The new study included 821 people from across the United States and parts of Canada who had a either a high-risk or moderate-risk exposure to a person who had tested positive and was ill from the coronavirus. None of the participants had symptoms themselves. High-risk exposure meant they were less than six feet from a patient for more than ten minutes, with neither a mask nor a face shield. Moderate risk meant they wore a mask, but no face shield.The new study included 821 people from across the United States and parts of Canada who had a either a high-risk or moderate-risk exposure to a person who had tested positive and was ill from the coronavirus. None of the participants had symptoms themselves. High-risk exposure meant they were less than six feet from a patient for more than ten minutes, with neither a mask nor a face shield. Moderate risk meant they wore a mask, but no face shield.
About 88 percent had high-risk exposures.About 88 percent had high-risk exposures.
The participants, recruited online, ranged in age from 33 to 50, with a median age of 40. About half were women, and 66 percent of the total were health care workers. They were healthy and had no underlying health problems that would have made hydroxychloroquine dangerous for them. Most of the rest had been exposed at home, to an infected spouse, partner or parent.The participants, recruited online, ranged in age from 33 to 50, with a median age of 40. About half were women, and 66 percent of the total were health care workers. They were healthy and had no underlying health problems that would have made hydroxychloroquine dangerous for them. Most of the rest had been exposed at home, to an infected spouse, partner or parent.
Within four days of exposure, the participants were picked at random to receive either hydroxychloroquine or a placebo, and then followed to determine whether they had either laboratory-confirmed Covid-19 or an illness consistent with the virus, during the next 14 days.Within four days of exposure, the participants were picked at random to receive either hydroxychloroquine or a placebo, and then followed to determine whether they had either laboratory-confirmed Covid-19 or an illness consistent with the virus, during the next 14 days.
The drug or placebos were mailed to them, and they then reported their symptoms online to the researchers, who did not examine them.The drug or placebos were mailed to them, and they then reported their symptoms online to the researchers, who did not examine them.
Not all the participants could be tested for the virus, because when the study was being conducted, there was still a shortage of test kits.Not all the participants could be tested for the virus, because when the study was being conducted, there was still a shortage of test kits.
There was no meaningful difference between the placebo group and those who took the drug. Among those taking hydroxychloroquine, 49 of 414, or 11.8 percent, became ill. In the placebo group, 58 or 407, or 14.3 percent, became ill. Analyzed statistically, the difference between those rates was not significant.There was no meaningful difference between the placebo group and those who took the drug. Among those taking hydroxychloroquine, 49 of 414, or 11.8 percent, became ill. In the placebo group, 58 or 407, or 14.3 percent, became ill. Analyzed statistically, the difference between those rates was not significant.
Updated June 2, 2020Updated June 2, 2020
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.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.
Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.
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.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.
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.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.
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.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.
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 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.)
More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
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.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.
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.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.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
The drug also did not make the illness any less severe.The drug also did not make the illness any less severe.
Side effects like nausea from hydroxychloroquine were more common than from placebos, 40.1 percent compared with 16.8 percent, but there were no problems with heart rhythm or any other serious adverse effects.Side effects like nausea from hydroxychloroquine were more common than from placebos, 40.1 percent compared with 16.8 percent, but there were no problems with heart rhythm or any other serious adverse effects.
Infectious disease experts who were not part of the study said it was well done and answered an important question, though the results were disappointing.Infectious disease experts who were not part of the study said it was well done and answered an important question, though the results were disappointing.
Dr. William Schaffner, an infectious disease specialist at Vanderbilt University, said: “This was a large, randomized controlled trial done by very good people. Hydroxychloroquine did not provide a notable advantage.”Dr. William Schaffner, an infectious disease specialist at Vanderbilt University, said: “This was a large, randomized controlled trial done by very good people. Hydroxychloroquine did not provide a notable advantage.”
Noting that the drug had shown some ability to prevent the virus from infecting cells in laboratory studies, Dr. Schaffner said, “Unfortunately that did not translate into a beneficial effect in preventing the development of illness.”Noting that the drug had shown some ability to prevent the virus from infecting cells in laboratory studies, Dr. Schaffner said, “Unfortunately that did not translate into a beneficial effect in preventing the development of illness.”
The study did not address the question of whether hydroxychloroquine can prevent coronavirus infection if people take it before they are exposed to a sick patient. That possibility is being studied in other clinical trials involving health care workers and emergency medical technicians and other emergency medical workers.The study did not address the question of whether hydroxychloroquine can prevent coronavirus infection if people take it before they are exposed to a sick patient. That possibility is being studied in other clinical trials involving health care workers and emergency medical technicians and other emergency medical workers.
At a Senate hearing on the F.D.A.’s oversight of foreign drug manufacturing on Tuesday, Democrats criticized the agency for its decision in March to give an emergency use authorization to hydroxychloroquine.At a Senate hearing on the F.D.A.’s oversight of foreign drug manufacturing on Tuesday, Democrats criticized the agency for its decision in March to give an emergency use authorization to hydroxychloroquine.
“The F.D.A., in my view, bowed to the pressure and issued what’s called an ‘emergency use authorization’ for the drug,” said Sen. Ron Wyden of Oregon, the ranking Democrat on the Senate Committee on Finance, which sponsored the hearing. “Doing so threw open the door to tens of millions of pills, including some, directly related to this hearing, manufactured inside facilities in Pakistan and India that have either failed F.D.A.’s inspection or never been inspected by the F.D.A. at all.”“The F.D.A., in my view, bowed to the pressure and issued what’s called an ‘emergency use authorization’ for the drug,” said Sen. Ron Wyden of Oregon, the ranking Democrat on the Senate Committee on Finance, which sponsored the hearing. “Doing so threw open the door to tens of millions of pills, including some, directly related to this hearing, manufactured inside facilities in Pakistan and India that have either failed F.D.A.’s inspection or never been inspected by the F.D.A. at all.”
Sheila Kaplan contributed reporting.Sheila Kaplan contributed reporting.