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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
(about 11 hours 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 large 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 also the first to test whether the drug could prevent illness in people who have been exposed to the coronavirus.The study was the first large 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 also 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.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 were published in The New England Journal of Medicine.The results were 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.
Regardless, 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.Regardless, 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.
But several studies on sick patients, without control groups, have found no benefit and even possible harm from the drug. A recent Lancet study reported increased risks of heart problems and death. Shortly after it was published, the World Health Organization suspended trials of the drug.But several studies on sick patients, without control groups, have found no benefit and even possible harm from the drug. A recent Lancet study reported increased risks of heart problems and death. Shortly after it was published, the World Health Organization suspended trials of the drug.
But the Lancet data has been called into question. On Wednesday, the World Health Organization said it would resume the trials it had suspended.But the Lancet data has been called into question. On Wednesday, the World Health Organization said it would resume the trials it had suspended.
Dr. Soumya Swaminathan, the deputy director of the W.H.O., said, “As of now, there is no evidence that any drug actually reduces the mortality in patients who have Covid-19, and in fact it is an urgent priority for all of us to do the needed studies, to do the randomized clinical trials in order to get that evidence as quickly as possible.”Dr. Soumya Swaminathan, the deputy director of the W.H.O., said, “As of now, there is no evidence that any drug actually reduces the mortality in patients who have Covid-19, and in fact it is an urgent priority for all of us to do the needed studies, to do the randomized clinical trials in order to get that evidence as quickly as possible.”
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.
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.
Updated June 16, 2020Updated June 16, 2020
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.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.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.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.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.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.
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.
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.
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.)
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.
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.”
An editorial accompanying the study pointed out some limitations: the lack of testing made it impossible to know for sure how many participants actually had Covid-19, and only 75 percent in the hydroxychloroquine group took the full course (some quit because of side effects). In addition, waiting four days after exposure to begin taking the drug may not have given it a chance to work, and starting it earlier might have had a different result.An editorial accompanying the study pointed out some limitations: the lack of testing made it impossible to know for sure how many participants actually had Covid-19, and only 75 percent in the hydroxychloroquine group took the full course (some quit because of side effects). In addition, waiting four days after exposure to begin taking the drug may not have given it a chance to work, and starting it earlier might have had a different result.
The editorialist, Dr. Myron S. Cohen from the University of North Carolina, called the results more provocative than definitive, and wrote, “the potential prevention benefits of hydroxychloroquine remain to be determined.”The editorialist, Dr. Myron S. Cohen from the University of North Carolina, called the results more provocative than definitive, and wrote, “the potential prevention benefits of hydroxychloroquine remain to be determined.”
The study did not address the question of whether hydroxychloroquine can prevent coronavirus infection if people take it before they are exposed to sick patients. 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 sick patients. 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.”
Jeremy Kahn, an F.D.A. spokesman, said the agency has done nine “mission-critical” drug facility inspections, including overseas and domestic, since March. But he did not say whether they involved hydroxychloroquine. He also said the agency would not resume regular overseas inspections until the State Department has given the go-ahead for travel.Jeremy Kahn, an F.D.A. spokesman, said the agency has done nine “mission-critical” drug facility inspections, including overseas and domestic, since March. But he did not say whether they involved hydroxychloroquine. He also said the agency would not resume regular overseas inspections until the State Department has given the go-ahead for travel.
Sheila Kaplan contributed reporting.Sheila Kaplan contributed reporting.