The Lancet Respiratory Medicine: Clinical trial finds inhaled immune response protein increases odds of recovery for hospitalised COVID-19 patients
Peer-reviewed / Randomised Controlled Trial / People
- Inhaled delivery of a formulation of a key protein involved in the immune response – interferon beta-1a – to hospitalised COVID-19 patients in the UK reduced the odds that they would develop severe disease or die from SARS CoV-2 infection.
- Those patients who received inhaled interferon beta-1a were more than twice as likely to recover from COVID-19 infection to a point where everyday activities were not limited compared with those who received a placebo.
- The trial included 101 patients, with the data providing strong rationale for larger studies to further investigate the impact of this treatment on clinical outcomes.
Hospitalised COVID-19 patients in the UK who received an inhaled form of interferon beta-1a (SNG001) were more likely to recover and less likely to develop severe symptoms than patients who received a placebo, according to a new clinical trial published in The Lancet Respiratory Medicine journal. This is the first evidence published in a peer-reviewed medical journal that inhaled interferon beta-1a could lessen the clinical consequences of COVID-19 and serves as proof-of-concept that this treatment could help hospitalised patients recover, but further research is required.
As the number of COVID-19 infections continues to rise around the world, there is a pressing need to develop new treatments for the more severe and life-threatening symptoms such as pneumonia and respiratory failure.
Interferon beta is a naturally occurring protein that coordinates the body’s immune response to viral infections. Laboratory studies have found that the SARS CoV-2 virus directly suppresses the release of interferon beta, while clinical trials demonstrate decreased activity of this important protein in COVID-19 patients. The formulation of interferon beta used in this new study – SNG001 – is directly delivered to the lungs via inhalation and has been trialled in the treatment of asthma and chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the safety and efficacy of SNG001 to treat hospitalised COVID-19 patients.
The trial was conducted at nine UK hospitals with patients who had a confirmed SARS-CoV-2 infection. It compared the effects of SNG001 and placebo given to patients once daily for up to 14 days, and followed up patients for a maximum of 28 days after starting the treatment. Patients were recruited from March 30 to May 30, 2020, and were randomly assigned to receive the treatment or a placebo. All members of the research team were blinded to which group the patients were allocated. During the study, changes in the clinical condition of patients were monitored.
Of the 101 patients enrolled in the study, 98 patients were given the treatment in the trial (three patients withdrew from the trial) – 48 received SNG001 and 50 received a placebo. At the outset of the trial 66 (67%) patients required oxygen supplementation at baseline (29 people in the placebo group and 37 in the SNG001 group). Patients who received SNG001 were twice as likely to show an improvement in their clinical condition at day 15 or 16, compared with
Nov. 2 (UPI) — People who have high blood pressure at night are at increased risk for heart disease, even if their blood pressure is within normal ranges during the day, according to a study published Monday by the journal Circulation.
A nighttime systolic blood pressure — the “top” number — that is 20 millimeters of mercury — or mm. Hg, the unit of measure for blood pressure — above daytime readings raises a person’s risk for heart disease by 18%, the data showed.
That same rise in nighttime blood pressure also increases a person’s risk for heart failure by 25%, the researchers said.
“Nighttime blood pressure is increasingly being recognized as a predictor of cardiovascular risk,” study co-author Dr. Kazuomi Kario said in a statement.
“This study provides much more in-depth information about the cardiovascular risk associated with high nighttime blood pressure,” said Kario, a professor of cardiovascular medicine at Jichi Medical University in Japan.
Nearly half of all adults in the United States — or 108 million people — have high blood pressure, the Centers for Disease Control and Prevention estimates.
Research suggests that up to 40% of people experience rises in systolic blood pressure at night, whether or not their blood pressure is considered normal or healthy — between 90 mm. Hg and 120 mm. Hg — during the day.
For this study, researchers measured daytime and nighttime systolic blood pressure in 6,359 adults from across Japan between 2009 and 2017, using an at-home, wearable, ambulatory monitor.
Blood pressure was recorded during daily activities and sleep for at least 24-hours at a time, and device data were periodically downloaded at a healthcare clinic, the researchers said.
Nearly half of the study participants were male, and more than half were aged 65 years and older, according to the researchers.
All of the study participants had at least one risk factor for heart disease — although none had been diagnosed with it — and 75% of them were taking blood pressure medications when the study began, the researchers said.
The study participants were instructed to rest or sleep during nighttime hours and maintain their usual daytime activities, and they recorded their daily activities and sleep and wake times in a diary.
Nearly every participant recorded 20 daytime and seven nighttime automated blood pressure measurements.
By the end of the study period, participants experienced a total of 306 cardiovascular events, including 119 strokes, 99 diagnoses of coronary artery disease and 88 diagnoses of heart failure.
Those with a disrupted circadian blood pressure rhythm — or higher blood pressure at night than during the day — had a 48% higher risk for heart disease and were nearly three times as likely to experience heart failure, the data showed.
Circadian rhythms are the body’s natural, internal process that regulates a person’s sleep-wake cycle and repeats with each rotation of the Earth, or roughly every 24 hours, according to the American Heart Association.
Blood pressure typically fluctuates with a pattern that follows the
Oct. 21 (UPI) — Older adults who used opioid pain medications before minor surgery were up to 68% more likely to die within 90 days of the procedure compared with those who never used the drugs, an analysis published Wednesday by JAMA Surgery found.
Even among people older than 65 who had low levels of opioid use as long as eight months before surgery, about 55 people per 10,000 in the general population died within 90 days of having a procedure, the data showed.
Older adults who had not used opioid pain drugs prior to surgery died at a rate of just over 40 per 10,000 in the general population within 90 days of having a minor procedure, the researchers said.
“People who have preoperative exposure to opioids have a higher risk of mortality after outpatient surgery,” study co-author Dr. Katherine Santosa told UPI.
“Although our analysis cannot discern the underlying causes for this, our findings highlight the need to screen for opioid-related risk prior to surgery,” said Santosa, a surgeon at Michigan Medicine.
Opioids were the leading cause of drug overdose deaths in the United States in the first half of 2019, according to data released recently by the U.S. Centers for Disease Control and Prevention.
Much of the country has been in the grips of an “epidemic” of illegal opioid use and overdose deaths over the past 40 years, causing more than 1 million deaths, based on agency estimates.
At least some of this increase in use has been attributed to over-prescription for pain treatment, the CDC has said.
For this study, Santosa and her colleagues reviewed data on more than 99,000 Medicare beneficiaries — age 65 and older — who had outpatient surgical procedures between 2009 and 2015.
Outpatient procedures do not entail an overnight hospital stay, and patients are admitted, have surgery and are discharged the same day.
Patients included in the analysis had procedures ranging from varicose vein removal and hemorrhoid removal to trans-urethral prostate surgery, thyroid removal, carpal tunnel release, umbilical hernia repair and inguinal hernia repair, the researchers said.
Among outpatient surgery patients included in the study, 0.48% died within 90 days of having their procedure, the data showed.
However, those with “high” levels of opioid use — for 10 months or more and within one month — before surgery were 68% more likely to die within 90 days of their procedure, the researchers said.
In addition, those with low or medium use before surgery were 30% more likely to die, the data showed.
“Many Americans currently use opioids prior to surgery for a variety of conditions,” Santosa said.
“In this context, it is important to understand the potential impact of opioids on recovery, and create care pathways to decrease the risk of adverse effects [while undergoing surgery],” she said.
At least seven states have set new records for single-day increases in coronavirus cases, prompting some to set new restrictions as concerns mount over possible “superspreader events” during the upcoming holiday season.
Colorado, Idaho, Indiana, Minnesota, New Mexico, North Dakota and West Virginia all set records Friday in the number of new cases of the virus, NBC News’ tally shows.
Colorado recorded 1,312 cases Friday, the same day Denver’s mayor announced both a tougher mask mandate that requires residents to wear face coverings outdoors and a limit on gatherings in “unregulated settings” to no more than five people.
“Over the past several weeks, we have worked hard to reduce our caseloads and keep hospitalizations from increasing,” Mayor Michael Hancock said in a press release. “But we need to do more. With the holidays on the horizon, we must take these additional steps over the next 30 days and knuckle down together to do the hard work that needs to be done so we can all enjoy this upcoming holiday season.”
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The mask mandate remains in effect until further notice, while the limit on gatherings is through Nov. 16.
Idaho recorded 1,094 new cases Friday, while Indiana and Minnesota each reported more than 2,200 cases, according to NBC’s data.
The governor of Idaho, Brad Little, said Thursday that the state was going to stay in stage 4 of his reopening plan after having failed to meet the criteria for a full reopening for the ninth time in a row, the Idaho Statesman reported.
Little urged residents to continue wearing masks and practicing social distancing.
“Our personal actions work better to slow the spread of coronavirus than anything else,” the governor said, according to the outlet. “This is about personal responsibility, something Idaho is all about.”
Minnesota Health Commissioner Jan Malcolm said she was “very saddened” about the rise in cases, although she said some of it can be attributed to more testing.
“Some of the things that we maybe thought was O.K. to do a month or so ago is much, much riskier today just given this level of viral spread around our state,” she told MinnPost.
North Dakota and New Mexico also broke daily records Friday with 859 cases and 812, respectively. West Virginia and Wyoming each reported just under 500 new cases that day.
A spokeswoman for the New Mexico governor’s office called the increase in that state a “Covid-19 wildfire,” the Santa Fe New Mexican reported.
“The virus spreads when people give it the opportunity to spread, and New Mexicans are doing just that,” spokeswoman Nora Meyers Sackett said.
In Wisconsin, health officials urged residents not to gather with anyone outside of their immediate families.
“I think people should think about all of the things that they’re doing outside of the confines of their immediate families as a potential place that they could be coming into contact with Covid-19,” said Andrea Palm, with the state’s Department of Health Services. “Now