Physician-Mother Investigates Son’s Mysterious Illness

The 9-year-old son of Fatema Nekooie, MD, suddenly threw up on a weekend night in mid-June. Nekooie guessed she was up against a gastrointestinal virus and a sleepless night ― maybe two. A colleague in pediatrics affirmed her suspicions.

But Kiarash’s nausea, vomiting, and abdominal pain were only the first in a series of unexplained symptoms that spurred an intense and ongoing medical investigation. Nekooei, a cardiologist in Bushehr, Iran, combined her roles as mother and physician and used every resource and connection she had.



Nekooei and 9-year-old Kiarash.

Kiarash’s initial symptoms resolved after 5 days. But a few days after that, Nekooei noticed swelling and erythema of her son’s genitals while she was bathing him. On the way to the emergency department, she called a urologist, who ordered labs and an ultrasound of the genital region. The sonography came back normal, but Kiarash’s white blood cell (WBC) count was up to 21,000/μL, nearly double what it had been when he was tested just days earlier.

A repeat sonography the next morning showed a small increase in blood flow to the right epididim. The doctor ordered a course of antibiotics, and on the second day, the swelling disappeared. All the physicians who examined him at the hospital believed the swelling must have been in response to a virus. After 2 days, they sent Kiarash home and told Nekooei to follow up in a month. “His doctors told me that we should be patient,” Nekooei told Medscape.

Her son’s abdominal pain came back in mid-July, accompanied by skin lesions along his cheek, chin, and neck. Nekooei ordered labs. His WBC count had skyrocketed to 37,000/μL, with 55% eosinophils.

Looking for help, she posted a description of her son’s evolving symptoms and lab test results on Medscape Consult, a social media platform where doctors share cases and advice on patient care. Her post quickly gained more than 100 responses and a global following. “All your advices [sic] will be useful for better management,” she wrote. She left her telephone and WhatsApp numbers for direct contact.

“It’s Very Difficult to Be in This Position”

Her son’s mysterious symptoms brought up painful memories for Nekooei. A few years earlier, her husband had suffered from an unclear illness. He had an abdominal mass, his platelet count was decreased, and he bruised easily. There were any number of possible diagnoses. “Many tests could not be done in Iran,” Nekooei said. His physicians were unable to determine the cause of his symptoms, and he came close to dying.

Her husband recovered after a splenectomy, but the near loss and painful memory of her own limitations still cause Nekooei grief. She cried when retelling the story. “It’s very difficult to be in this position,” Nekooei told Medsape, one where her medical training and resources aren’t enough. Watching her son’s symptoms this summer, once again, her medical expertise felt wildly insufficient.

Her son’s high WBC counts immediately made her think about malignancies. Nekooei called hematologist and oncologist Nader Shakibazad,

Johnson & Johnson Pauses COVID-19 Vaccine Clinical Trials over Participant’s ‘Unexplained Illness’

Johnson & Johnson has paused its late stage clinical trials for a COVID-19 vaccine because of an “unexplained” illness in one of the participants, the company said Monday. 

It said in a news release that the trial was paused while the study’s independent Data Safety Monitoring Board conducted a review and evaluation of the participant’s condition.

“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

The company noted the “significant distinction” between a study pause and a regulatory hold, explaining that a pause is not unexpected in vaccine trials. 

“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the statement said.

Johnson & Johnson’s coronavirus vaccine became the fourth to begin Phase 3 trials in the United States last month and becomes the second to be paused in the U.S. after AstraZeneca’s vaccine trial was put on hold last month after a volunteer in Britain developed a neurological complication.

AstraZeneca’s trial has resumed in Britain, but is still paused in the United States as the U.S. Food and Drug Administration carries out an investigation.

Johnson & Johnson did not reveal the specifics of the unexplained illness but will be conducting a review to see if it is related to the vaccine. 

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said.

“Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”

When the trial’s move to Phase 3 was announced last month, the National Institutes of Health said it would involve up to 60,000 participants. 

The company’s vaccine is one of six being tested in the U.S. in the race to find an effective vaccine to ease the pandemic that has killed more than 215,000 Americans.

Johnson & Johnson’s vaccine requires only one dose of vaccine, so federal officials have expressed hope that testing can be carried out faster than studies of other vaccines which will require two doses, such as those made by Moderna and Pfizer, CNN reported. 

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J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

(Reuters) – Johnson & Johnson

has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca

also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

(Reporting by Ayanti

J&J pauses coronavirus vaccine trials due to unexplained illness

(Reuters) – Johnson & Johnson JNJ.N has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca AZN.L also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported here the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

Reporting

J&J pauses COVID-19 vaccine trials due to illness [Video]

Johnson & Johnson announced Monday (October 12) it’s temporarily paused trials for a COVID-19 vaccine after a participant in the study fell ill for unknown reasons.

The news delays one of the highest profile efforts to contain the global pandemic.

And also another major setback in the race for a COVID-19 vaccine, after AstraZeneca paused late-stage trials of its vaccine candidate last month, also due to unexplained illness in a trial participant.

Johnson and Johnson said in a statement that their participant’s illness is being reviewed and evaluated by an independent monitoring board as well as the company’s clinical and safety physicians.

The company said that the current “study pause” in giving doses of the vaccine was different from a “regulatory hold” required by health authorities.

It added that such pauses are normal in big trials, which can include tens of thousands of people.

J&J had kicked off its final 60,000-person trial just last month, the results of which were expected by the end of this year or early 2021.

Johnson & Johnson declined to elaborate on the participant’s illness due to privacy concerns.

But the company says that some participants in studies get placebos, and it can be unclear whether a person suffering a serious illness in a clinical trial received a placebo or the treatment.

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How Long Can I Expect a COVID-19 Illness to Last? | Health News

How long can I expect a COVID-19 illness to last?

It depends. Most coronavirus patients have mild to moderate illness and recover quickly. Older, sicker patients tend to take longer to recover. That includes those who are obese, or have high blood pressure and other chronic diseases.

The World Health Organization says recovery typically takes two to six weeks. One U.S. study found that around 20% of non-hospitalized individuals ages 18 to 34 still had symptoms at least two weeks after becoming ill. The same was true for nearly half of people age 50 and older.

Among those sick enough to be hospitalized, a study in Italy found 87% were still experiencing symptoms two months after getting sick. Lingering symptoms included fatigue and shortness of breath.

Dr. Khalilah Gates, a Chicago lung specialist, said many of her hospitalized COVID-19 patients still have coughing episodes, breathing difficulties and fatigue three to four months after infection.

She said it’s hard to predict exactly when COVID-19 patients will return to feeling well.

“The unsettling part of all this is we don’t have all the answers,” said Gates, an assistant professor at Northwestern University Feinberg School of Medicine.

It’s also hard to predict which patients will develop complications after their initial illness subsides.

COVID-19 can affect nearly every organ, and long-term complications can include heart inflammation, decreased kidney function, fuzzy thinking, anxiety and depression.

It is unclear whether the virus itself or the inflammation it can cause leads to these lingering problems, said Dr. Jay Varkey, an Emory University infectious diseases specialist.

“Once you get over the acute illness, it’s not necessarily over,” he said.

The AP is answering your questions about the coronavirus in this series. Submit them at: [email protected]

Read previous Viral Questions:

Am I immune to the coronavirus if I’ve already had it?

Can the coronavirus travel more than 6 feet in the air?

Does the coronavirus spread easily among children?

Copyright 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Johnson & Johnson COVID-19 vaccine trial paused due to ‘unexplained illness’

Johnson & Johnson on Monday night announced that it has paused its COVID-19 vaccine trial due to one of the volunteers coming down with an “unexplained illness.”

In a statement, Johnson & Johnson said that under its guidelines, the “participant’s illness is being reviewed and evaluated” by the study’s independent Data Safety Monitoring Board (DSMB), as well as internal clinical and safety physicians. The company also said that “adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

Johnson & Johnson’s vaccine arm, Janssen, began the Phase 3 clinical trial in September. There are 60,000 participants, and each are receiving one dose of the vaccine. Advanced clinical trials are conducted so researchers can determine whether participants are experiencing side effects, and Johnson & Johnson said it is not revealing what illness the volunteer has due to privacy reasons.

Dr. Ashish Jha, dean of the Brown University School of Public Health, told CNN that the pause is “completely expected” due to how large the study is, and this is “just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3.” Jha added that it is important for the vaccine to be “safe and we’ve got to let the process play out and it’s going to take a while. To me, it’s reassuring that companies are acting responsibly and pausing when they need to.”

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Johnson & Johnson pauses clinical trials for a COVID vaccine over patient illness

Johnson & Johnson has paused its clinical trials for a COVID-19 vaccine following a patient illness, just weeks after it announced it was in its final stage.

A pause is not entirely unexpected in vaccine trials. When another vaccine trial was temporarily stopped last month, experts hailed the move, pointing to it as an example of the scientific rigor that is being maintained despite the understandably intense public interest for a COVID-19 vaccine.

The Johnson & Johnson trial was paused after an “unexplained” illness in one of its participants and in compliance with regulatory standards, the company said in a news release Monday night. The pharmaceutical company said the patient’s condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board.

“We must respect this participant’s privacy,” the company’s statement said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

It’s unclear whether the patient received the experimental vaccine or were in the placebo-control group.

AstraZeneca also started its Phase 3 vaccine trial last month but was placed on pause in the U.S. after a participant in the United Kingdom was reported to have developed a spinal cord injury. The company resumed its trial with Oxford University in the U.K. but was awaiting Food and Drug Administration approval to continue in the U.S.

Dr. Francis Collins, director of the National Institutes of Health, told NBC News last month that the pause should reassure those with concerns about possible vaccine safety issues.

“If anybody thinks we’re just glossing over these kinds of issues in the big rush to approve a vaccine, this ought to be reassuring,” Collins said during a “Doc to Doc” interview with NBC News medical correspondent Dr. John Torres, which was streamed on Facebook.

Pfizer and Moderna also have vaccine trials that went into Phase 3 in July, both of which require two doses about a month apart. The Johnson & Johnson vaccine is instead administered in one dose, avoiding the complicated coordination to require that people return in time for the second dose.

Johnson & Johnson announced last week that European Commission approved an advance purchase agreement from its parent company, Janssen Pharmaceutical Companies, for 200 million doses of the vaccine to E.U. member states following approval. The company also said it was looking to allocate up to 500 million vaccine doses toward international efforts for low-income nations.

This story originally appeared on NBCNews.com.

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Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

Budrul Chukrut | LightRocket | Getty Images

The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.

More from STAT News

Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement.

J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.

The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.

Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.

Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said.

“If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.”

On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. 

Johnson and Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

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Analyzing Trump’s illness is humbling for media’s med teams

NEW YORK (AP) — Here’s an assignment to humble even the most confident doctor: Assess a patient’s condition before millions of people without being able to examine him or see a complete medical chart.

That, in effect, is what medical experts at news organizations have been asked to do since President Donald Trump revealed Friday that he had tested positive for COVID-19.

They have a fine line to walk, needing to decide what level of speculation — if any — that they’re comfortable with, how much to read into medications the president has been prescribed and how to explain the course of a virus so new that it still confounds the people who study it.

“You try to put the pieces of the puzzle together,” said CNN’s Dr. Sanjay Gupta, who logged hours comparable to his residency days in the wake of Trump’s announcement.

A second or third opinion is only a click away. The question of whether Trump developed COVID 19-related pneumonia is one example of how media experts have differed despite access to the same information.


All would like to see images of Trump’s lungs, but they haven’t been made available. Dr. Vin Gupta (no relation to Sanjay), a pulmonologist who treats coronavirus patients and reports for NBC News, is confident that Trump has pneumonia because the president has had shortness of breath, low oxygen levels in his blood and has COVID-19.

CBS News’ Dr. John LaPook is less definitive, but believes that’s the case “because if he had a chest x-ray and it was normal, they would be shouting it from the rooftops.”

But Dr. Jen Ashton, ABC News’ chief medical correspondent, said that would be “quintessential speculation” because the president’s medical team hasn’t made that diagnosis publicly. His doctors said there were some pulmonary findings on imaging tests, but there are other things that could mean besides pneumonia.

“We don’t know what the findings were, and that is precisely why I didn’t jump to conclusions,” Ashton said.

For Vin Gupta, however, “this is my wheelhouse.

“What might be speculative for another journalist, for me there’s a level of concreteness that I feel exists that I try to pass along,” he said.

Ashton also objects to how some in the media have pinned percentages on Trump’s likely survival. Dr. Martin Makary said on Fox News Channel that Trump had a 99.4 percent chance of surviving COVID-19; CNN’s Gupta said it’s “90 to 95 percent” that he’ll get through.

“This has been very, very challenging,” Ashton said. “The way that I’ve handled this is that I do not speculate. And one of my pet peeves in this story, as it is in all medical media, is when everyone with an ‘MD’ after their name thinks that they can offer inside baseball.”

Imagine the confusion visitors to newsstands in Massachusetts might have felt on Monday. “Trump is improving, doctors say,” was the banner headline on the Wall Street Journal. “Fresh concerns on Trump’s health,” headlined the Boston Globe.

The