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| Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients | Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients |
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| An experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday. | An experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday. |
| The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of Covid-19, but it has caught the attention of Rudy Giuliani, President Trump’s personal lawyer. Mr. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has “real potential,” while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies. | The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of Covid-19, but it has caught the attention of Rudy Giuliani, President Trump’s personal lawyer. Mr. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has “real potential,” while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies. |
| There is no proven treatment for the respiratory disease, but several experimental approaches, including old malaria drugs and H.I.V. antivirals, are being tested in patients around the world. | There is no proven treatment for the respiratory disease, but several experimental approaches, including old malaria drugs and H.I.V. antivirals, are being tested in patients around the world. |
| Celularity has also enthusiastically publicized the news of its early-stage trial for its treatment, known as Cynk-001. In an email Wednesday to a reporter, its public relations firm described a development as the “first F.D.A. approval for Covid-19 cell therapy.” The agency’s decision, however, merely gives a green light for its product to be used in a clinical trial, not widely prescribed to patients. | Celularity has also enthusiastically publicized the news of its early-stage trial for its treatment, known as Cynk-001. In an email Wednesday to a reporter, its public relations firm described a development as the “first F.D.A. approval for Covid-19 cell therapy.” The agency’s decision, however, merely gives a green light for its product to be used in a clinical trial, not widely prescribed to patients. |
| In recent weeks, the established scientific process of evaluating a drug’s safety and effectiveness has been upended by Mr. Trump, who has repeatedly promoted the potential of two long-used malaria drugs that have shown mainly anecdotal evidence of helping patients. On Saturday, the F.D.A. took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done. | In recent weeks, the established scientific process of evaluating a drug’s safety and effectiveness has been upended by Mr. Trump, who has repeatedly promoted the potential of two long-used malaria drugs that have shown mainly anecdotal evidence of helping patients. On Saturday, the F.D.A. took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done. |
| The early trial by Celularity — which will primarily evaluate safety, as well as an initial look at efficacy — will test its therapy in up to 86 patients with symptoms. They will receive infusions of the cell therapy, in the hopes it will prevent them from developing the more severe form of the disease, Dr. Robert Hariri, Celularity’s founder and chief executive, said in an interview Wednesday. | The early trial by Celularity — which will primarily evaluate safety, as well as an initial look at efficacy — will test its therapy in up to 86 patients with symptoms. They will receive infusions of the cell therapy, in the hopes it will prevent them from developing the more severe form of the disease, Dr. Robert Hariri, Celularity’s founder and chief executive, said in an interview Wednesday. |
| “The objective here is preventative,” Dr. Hariri said. “If the timing of giving this can prevent those patients who have early disease from progressing to the more serious, life-threatening form, it could be a very, very useful tool.” | “The objective here is preventative,” Dr. Hariri said. “If the timing of giving this can prevent those patients who have early disease from progressing to the more serious, life-threatening form, it could be a very, very useful tool.” |
| The therapy involves using stem cells from the placenta — known as “natural killer” cells — that help protect a developing fetus or newborn from viruses that have infected the mother. Celularity has been testing these cells in cancer patients. | The therapy involves using stem cells from the placenta — known as “natural killer” cells — that help protect a developing fetus or newborn from viruses that have infected the mother. Celularity has been testing these cells in cancer patients. |
| Dr. Hariri said the trial, which would not include a placebo control group, will take place at academic medical centers around the country. He said the company expected to see initial results about 30 to 60 days after the first patients receive their dose. If this study is successful, Dr. Hariri said, the company would move to a placebo-controlled study that would evaluate the drug’s efficacy against the disease. | Dr. Hariri said the trial, which would not include a placebo control group, will take place at academic medical centers around the country. He said the company expected to see initial results about 30 to 60 days after the first patients receive their dose. If this study is successful, Dr. Hariri said, the company would move to a placebo-controlled study that would evaluate the drug’s efficacy against the disease. |
| At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems “by massive killing of the patients’ respiratory cells.” | At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems “by massive killing of the patients’ respiratory cells.” |
| Despite the scant evidence, Mr. Giuliani has become an early booster, interviewing Dr. Hariri on a podcast published on his website Saturday, and praising the treatment on Twitter, saying, “this therapy has real potential.” In a tweet on Saturday, he added, “Let’s hope F.D.A. can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.” | Despite the scant evidence, Mr. Giuliani has become an early booster, interviewing Dr. Hariri on a podcast published on his website Saturday, and praising the treatment on Twitter, saying, “this therapy has real potential.” In a tweet on Saturday, he added, “Let’s hope F.D.A. can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.” |
| Around the same time, Twitter deleted a post by Mr. Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Mr. Trump has supported. | Around the same time, Twitter deleted a post by Mr. Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Mr. Trump has supported. |
| Dr. Hariri said that he has known Mr. Giuliani for years and that the appearance on his podcast was “a friendly chat between people who know each other and who share a common interest in this particular response to this disease.” | Dr. Hariri said that he has known Mr. Giuliani for years and that the appearance on his podcast was “a friendly chat between people who know each other and who share a common interest in this particular response to this disease.” |
| Updated June 16, 2020 | |
| 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. |
| He said that he has no business relationship with Mr. Giuliani, and that Mr. Giuliani is not representing him in any way, either paid or unpaid. “I don’t have anything to do with what the mayor tweets or whatnot, and I don’t agree or disagree with anything,” he said. | He said that he has no business relationship with Mr. Giuliani, and that Mr. Giuliani is not representing him in any way, either paid or unpaid. “I don’t have anything to do with what the mayor tweets or whatnot, and I don’t agree or disagree with anything,” he said. |
| Dr. Hariri said the company would follow the established process for testing whether a drug works. “We have waited for the F.D.A. to complete their review, which they did in a heroic and quick fashion,” he said. | Dr. Hariri said the company would follow the established process for testing whether a drug works. “We have waited for the F.D.A. to complete their review, which they did in a heroic and quick fashion,” he said. |
| On Wednesday evening — the same day the F.D.A. approved his trial — Dr. Hariri praised the appearance by the agency’s commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show “The Ingraham Angle.” | On Wednesday evening — the same day the F.D.A. approved his trial — Dr. Hariri praised the appearance by the agency’s commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show “The Ingraham Angle.” |
| “We are fortunate to have Dr. Hahn at the helm,” he tweeted. | “We are fortunate to have Dr. Hahn at the helm,” he tweeted. |