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| At the Center of a Storm: The Search for a Proven Coronavirus Treatment | At the Center of a Storm: The Search for a Proven Coronavirus Treatment |
| (2 days later) | |
| OMAHA — Beginning every morning at 5:30, Dr. Andre Kalil makes himself a double espresso, runs 10 kilometers, makes additional double espressos for himself and his wife, and heads to his office at the University of Nebraska Medical Center. | OMAHA — Beginning every morning at 5:30, Dr. Andre Kalil makes himself a double espresso, runs 10 kilometers, makes additional double espressos for himself and his wife, and heads to his office at the University of Nebraska Medical Center. |
| A deluge awaits him. | A deluge awaits him. |
| Calls and insistent emails pile up each day. Patients and their doctors are clamoring for untested coronavirus treatments, encouraged by President Trump, who said that “we can’t wait” for rigorous studies of the anti-malarial drugs chloroquine and hydroxychloroquine, and that ill patients should have ready access to experimental medicines. | Calls and insistent emails pile up each day. Patients and their doctors are clamoring for untested coronavirus treatments, encouraged by President Trump, who said that “we can’t wait” for rigorous studies of the anti-malarial drugs chloroquine and hydroxychloroquine, and that ill patients should have ready access to experimental medicines. |
| Dr. Kalil, 54, is a principal investigator in the federal government’s clinical trial of drugs that may treat the coronavirus. It is starting with remdesivir, an antiviral drug. The first results will be ready within weeks. | Dr. Kalil, 54, is a principal investigator in the federal government’s clinical trial of drugs that may treat the coronavirus. It is starting with remdesivir, an antiviral drug. The first results will be ready within weeks. |
| Dr. Kalil, who has decades of experience grappling with questions about the use — and misuse — of experimental drugs, has rarely been more frustrated. He has seen what happens when desperation drives treatment decisions. “Many drugs we believed were fantastic ended up killing people,” he said in an interview. “It is so hard to keep explaining that.” | Dr. Kalil, who has decades of experience grappling with questions about the use — and misuse — of experimental drugs, has rarely been more frustrated. He has seen what happens when desperation drives treatment decisions. “Many drugs we believed were fantastic ended up killing people,” he said in an interview. “It is so hard to keep explaining that.” |
| Dr. Kalil is haunted by memories of the Ebola outbreak that ravaged Africa from 2014 to 2016. Then, too, doctors said they could not wait for scientific evidence, and untested drugs were given to suffering Ebola patients by optimistic physicians with noble intentions. In the long run, none of the drugs was ever approved in the United States for treatment of the disease. | Dr. Kalil is haunted by memories of the Ebola outbreak that ravaged Africa from 2014 to 2016. Then, too, doctors said they could not wait for scientific evidence, and untested drugs were given to suffering Ebola patients by optimistic physicians with noble intentions. In the long run, none of the drugs was ever approved in the United States for treatment of the disease. |
| Today, hope centers on chloroquine and hydroxychloroquine. These drugs have been tested in the laboratory against many viruses: SARS and MERS — both coronaviruses — as well as H.I.V., dengue, Ebola, chikungunya and influenza. But even when they seemed to work, what succeeded in the test tube did not succeed in real life, Dr. Kalil said. | Today, hope centers on chloroquine and hydroxychloroquine. These drugs have been tested in the laboratory against many viruses: SARS and MERS — both coronaviruses — as well as H.I.V., dengue, Ebola, chikungunya and influenza. But even when they seemed to work, what succeeded in the test tube did not succeed in real life, Dr. Kalil said. |
| In fact, the anti-malarial drugs have never been found to work against any viral disease, including Ebola. (Malaria is caused by a parasite, not a virus.) And the drugs have side effects, including damage to the liver and bone marrow, as well as heart rhythm disturbances that could be fatal in older people and young people with serious medical problems. | In fact, the anti-malarial drugs have never been found to work against any viral disease, including Ebola. (Malaria is caused by a parasite, not a virus.) And the drugs have side effects, including damage to the liver and bone marrow, as well as heart rhythm disturbances that could be fatal in older people and young people with serious medical problems. |
| Even worse, Dr. Kalil said, is the promotion of the antibiotic azithromycin in combination with the anti-malarial drugs to treat Covid-19 patients. Azithromycin also may cause serious heart rhythm problems, and the combination of drugs, Dr. Kalil said, has never been tested for safety in humans. | Even worse, Dr. Kalil said, is the promotion of the antibiotic azithromycin in combination with the anti-malarial drugs to treat Covid-19 patients. Azithromycin also may cause serious heart rhythm problems, and the combination of drugs, Dr. Kalil said, has never been tested for safety in humans. |
| That is not to say the drugs won’t help patients with the coronavirus, only that whether this is so is unknown. | That is not to say the drugs won’t help patients with the coronavirus, only that whether this is so is unknown. |
| “This is very charged emotionally,” Dr. Kalil said. “It is Ebola déjà vu.” | “This is very charged emotionally,” Dr. Kalil said. “It is Ebola déjà vu.” |
| Dr. Kalil, an infectious disease and intensive care specialist, is a principal investigator in an unusual federal trial that may shape the course of the coronavirus pandemic. | Dr. Kalil, an infectious disease and intensive care specialist, is a principal investigator in an unusual federal trial that may shape the course of the coronavirus pandemic. |
| Every surface in his office at the University of Nebraska Medical Center is piled with stacks of papers and folders — these days, there is no time to clean up. His lunch, at 3 p.m. on a recent afternoon, consisted of a turkey wrap and a bottle of water from a mini refrigerator. | Every surface in his office at the University of Nebraska Medical Center is piled with stacks of papers and folders — these days, there is no time to clean up. His lunch, at 3 p.m. on a recent afternoon, consisted of a turkey wrap and a bottle of water from a mini refrigerator. |
| Dr. Kalil is voluble, lean and energetic, an unabashed patriot whose family emigrated from Brazil decades ago. He can be confrontational, and has squared off with leading scientists when he feels their treatments cannot be justified by scientific evidence. | Dr. Kalil is voluble, lean and energetic, an unabashed patriot whose family emigrated from Brazil decades ago. He can be confrontational, and has squared off with leading scientists when he feels their treatments cannot be justified by scientific evidence. |
| He has participated in 22 marathons, and knows that now he is running in the most important race of all. As patients and the president alike demand treatments, he wants people to understand that testing is proceeding as quickly as possible. | He has participated in 22 marathons, and knows that now he is running in the most important race of all. As patients and the president alike demand treatments, he wants people to understand that testing is proceeding as quickly as possible. |
| “At the risk of sounding clichéd,” said Dr. John Lowe, assistant vice chancellor at the medical center, Dr. Kalil is “the type of person who elevates a team through his demeanor and approach to research.” | “At the risk of sounding clichéd,” said Dr. John Lowe, assistant vice chancellor at the medical center, Dr. Kalil is “the type of person who elevates a team through his demeanor and approach to research.” |
| There is no vaccine and no treatment for Covid-19, the respiratory illness caused by the coronavirus. As of Thursday, the virus has infected 1.5 million people worldwide, at least 430,000 in the United States alone, where it has killed more than 14,500 people. | There is no vaccine and no treatment for Covid-19, the respiratory illness caused by the coronavirus. As of Thursday, the virus has infected 1.5 million people worldwide, at least 430,000 in the United States alone, where it has killed more than 14,500 people. |
| Remdesivir, made by Gilead, was chosen to be the first treatment evaluated in the federal effort after investigators did a careful search for drugs that might be effective. It was designed to be a broad spectrum antiviral that stops the synthesis of genetic material in a variety of viruses. | Remdesivir, made by Gilead, was chosen to be the first treatment evaluated in the federal effort after investigators did a careful search for drugs that might be effective. It was designed to be a broad spectrum antiviral that stops the synthesis of genetic material in a variety of viruses. |
| Laboratory and animal studies suggested that remdesivir might be effective against coronaviruses, and safety studies had already been conducted in animals. The drug also was tested in animals infected with MERS and SARS, both caused by coronaviruses. | Laboratory and animal studies suggested that remdesivir might be effective against coronaviruses, and safety studies had already been conducted in animals. The drug also was tested in animals infected with MERS and SARS, both caused by coronaviruses. |
| “We don’t know if remdesivir will get into the lungs in a high enough concentration to kill the virus,” Dr. Kalil said of its possible use to treat Covid-19. “We don’t know if it will cause side effects.” | “We don’t know if remdesivir will get into the lungs in a high enough concentration to kill the virus,” Dr. Kalil said of its possible use to treat Covid-19. “We don’t know if it will cause side effects.” |
| It is even possible that taking the drug may hasten patients’ deaths. “That is why we need a randomized controlled trial,” he said. | It is even possible that taking the drug may hasten patients’ deaths. “That is why we need a randomized controlled trial,” he said. |
| Although remdesivir is not approved for treatment of any illness, Gilead provided the drug to Covid-19 patients under legal exceptions for “compassionate use.” But demand escalated to such an extent that the company announced last month that it would stop giving out the antiviral. | Although remdesivir is not approved for treatment of any illness, Gilead provided the drug to Covid-19 patients under legal exceptions for “compassionate use.” But demand escalated to such an extent that the company announced last month that it would stop giving out the antiviral. |
| “I would never give this or any other experimental drug off-label to my patients,” Dr. Kalil said. “There is nothing compassionate about compassionate use. You are treating emotion.” | “I would never give this or any other experimental drug off-label to my patients,” Dr. Kalil said. “There is nothing compassionate about compassionate use. You are treating emotion.” |
| The problem is not just that an experimental drug may not work or may endanger patients. It is also that if a drug is distributed to patients far and wide, no one will ever know if it works. | The problem is not just that an experimental drug may not work or may endanger patients. It is also that if a drug is distributed to patients far and wide, no one will ever know if it works. |
| If a Covid-19 patient takes remdesivir or chloroquine and dies, did the drug fail? Was the patient too far gone? Did the drug actually hasten death? | If a Covid-19 patient takes remdesivir or chloroquine and dies, did the drug fail? Was the patient too far gone? Did the drug actually hasten death? |
| Updated June 12, 2020 | |
| 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. | |
| 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. |
| 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. |
| 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.) |
| 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. |
| If the patient survives, was it because of the drug? In spite of it? Without a controlled trial, there’s no good answer, and no way to compare patients once the drug is handed out routinely. | If the patient survives, was it because of the drug? In spite of it? Without a controlled trial, there’s no good answer, and no way to compare patients once the drug is handed out routinely. |
| The trial Dr. Kalil leads is not the only one testing remdesivir against the coronavirus. But it is the only trial with the rigor to show whether this or other drugs work in the American population. | The trial Dr. Kalil leads is not the only one testing remdesivir against the coronavirus. But it is the only trial with the rigor to show whether this or other drugs work in the American population. |
| The research began in February with three patients who had been infected aboard the cruise ship Diamond Princess and were flown to the University of Nebraska Medical Center. | The research began in February with three patients who had been infected aboard the cruise ship Diamond Princess and were flown to the University of Nebraska Medical Center. |
| About 400 patients are now enrolled at various sites, and with that number the trial has enough patients for a preliminary analysis, now underway, which will determine if the experiment should continue with remdesivir. | About 400 patients are now enrolled at various sites, and with that number the trial has enough patients for a preliminary analysis, now underway, which will determine if the experiment should continue with remdesivir. |
| In the usual clinical trial, one drug is tested against a control substance — placebo or the standard-of-care drug — for a set period of time. The investigators are not permitted to see the data. | In the usual clinical trial, one drug is tested against a control substance — placebo or the standard-of-care drug — for a set period of time. The investigators are not permitted to see the data. |
| When the trial ends and the data is revealed, the researchers decide if the new drug is helpful. If it is not, the process must start over with a different drug. The experiments can take years. | When the trial ends and the data is revealed, the researchers decide if the new drug is helpful. If it is not, the process must start over with a different drug. The experiments can take years. |
| But Dr. Kalil is running a so-called adaptive trial. Researchers start by comparing an experimental drug — in this case, remdesivir — to the placebo. After a comparatively short period of time, they peek at the data. | But Dr. Kalil is running a so-called adaptive trial. Researchers start by comparing an experimental drug — in this case, remdesivir — to the placebo. After a comparatively short period of time, they peek at the data. |
| If patients taking remdesivir are faring better than those taking the placebo, the study will move on to a second phase in which another drug is tested against remdesivir, which becomes the trial’s control. | If patients taking remdesivir are faring better than those taking the placebo, the study will move on to a second phase in which another drug is tested against remdesivir, which becomes the trial’s control. |
| The point is to find something that shows some efficacy quickly, and there is no specific stopping point. | The point is to find something that shows some efficacy quickly, and there is no specific stopping point. |
| If a drug were to bring the mortality rate to zero, of course, the trial would end abruptly and that drug would become the standard of care. If a drug were shown to halve the mortality rate, however, the question gets trickier. | If a drug were to bring the mortality rate to zero, of course, the trial would end abruptly and that drug would become the standard of care. If a drug were shown to halve the mortality rate, however, the question gets trickier. |
| “Is that good enough?” Dr. Kalil wondered. | “Is that good enough?” Dr. Kalil wondered. |
| He declined to say which drugs are in line for testing after remdesivir, concerned that he might set off another wave of demand for unproven drugs. | He declined to say which drugs are in line for testing after remdesivir, concerned that he might set off another wave of demand for unproven drugs. |
| In addition to criticizing the demand for the drug under compassionate use, Dr. Kalil also lamented publication of case studies in prestigious medical journals of single patients who took an untested drug. | In addition to criticizing the demand for the drug under compassionate use, Dr. Kalil also lamented publication of case studies in prestigious medical journals of single patients who took an untested drug. |
| “Publishing a single case report of an experimental drug as an original article in a high-impact journal during an outbreak is akin to sensationalist news,” he said. | “Publishing a single case report of an experimental drug as an original article in a high-impact journal during an outbreak is akin to sensationalist news,” he said. |
| “We must do better than that to save lives during a pandemic,” he said. | “We must do better than that to save lives during a pandemic,” he said. |