© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

By Leroy Leo and Michael Erman

(Reuters) – The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown the drug to be an effective therapeutic for fighting the virus.

“Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization,” the agency said in a document https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/EUA%20110%20Fluvoxamine%20Decisional%20Memo_Redacted.pdf published on Monday.

University of Minnesota professor Dr. David Boulware submitted the emergency use authorization request to the FDA that would have allowed doctors to prescribe fluvoxamine maleate to treat COVID-19 in non-hospitalized patients.

The generic drug belongs to an old, widely-used class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

Boulware said that his request is less urgent with the availability of drugs like Pfizer Inc (NYSE:PFE)’s Paxlovid, but he still believes the data supports the drug’s use in some COVID patients.

“There are effective therapeutics that are available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications,” Boulware said in an interview. “And if you go elsewhere in the world, low- and middle-income countries, they have access to no therapeutics.”

Boulware’s submission relied on data from three trials, especially a study of 1,497 non-hospitalized COVID patients in Brazil.

While the Brazilian study met its primary endpoint, showing a roughly 30% drop in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment, which measured reduction in emergency department visits lasting more than 6 hours.

Boulware said FDA had used a different measure to count hospitalizations in other drug trials, including only acute care that lasted at least 24 hours.

“The standard that they were holding for fluvoxamine was a different standard than the other big pharma trials, with Paxlovid and (Merck’s) molnupiravir and the monoclonals,” he said of other authorized COVID therapeutics.

“I was really quite disappointed that they did that,” he said.

© Reuters. A firefighter from the Marins-Pompiers of Marseille (Marseille Naval Fire Battalion) administers a nasal swab to a child at a testing site for coronavirus disease (COVID-19) in Marseille, France, September 17, 2020. REUTERS/Eric Gaillard

By Nancy Lapid

(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

SARS-CoV-2 could be at root of mysterious hepatitis in kids

A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.

Children with COVID-19 are at significantly increased risk for liver dysfunction afterward, according to a report posted on Saturday on medRxiv ahead of peer review https://www.medrxiv.org/content/10.1101/2022.05.10.22274866v1. But most of the children with acute hepatitis – which is generally rare in that age group – do not report a previous SARS-CoV-2 infection. Instead, the majority have been found to be infected with an adenovirus called 41F, which is not known to attack the liver. It is possible that the affected children, many of whom are too young to be vaccinated, may have had mild or asymptomatic COVID infections that went unnoticed, a separate team of researchers suggest in The Lancet Gastroenterology & Hepatology https://www.sciencedirect.com/science/article/pii/S2468125322001662. If that were true, they theorize, then lingering particles of the coronavirus in the gastrointestinal tract in these children could be priming the immune system to over-react to adenovirus-41F with high amounts of inflammatory proteins that ultimately damage the liver.

“We suggest that children with acute hepatitis be investigated for SARS-CoV-2 persistence in stool” and for other signals that the liver damage is happening because the spike protein of the coronavirus is a “superantigen” that over-sensitizes the immune system, they said.

Face-down position unhelpful for awake patients

For hospitalized COVID-19 patients who are breathing on their own but with supplemental oxygen, lying face down might not help prevent them from eventually needing mechanical ventilation, according to a new study.

In the study, 400 patients were randomly assigned to usual care or to standard care plus intermittently lying on their stomach, a position known to improve the course of illness in sedated patients on mechanical ventilators. Over the next 30 days, 34.1% in the prone-positioning group and 40.5% in the usual-care group needed to be intubated and put on a ventilator, a difference that was not statistically significant. There might have been a reduction in the risk for intubation with prone positioning among some of the patients, researchers said on Monday in JAMA https://jamanetwork.com/journals/jama/fullarticle/2792506, but they could not confirm it statistically from their data. The average duration of prone positioning per day was roughly five hours, less than the target of eight to 10 hours per day.

“Long hours of awake prone positioning are challenging and highly influenced by patient comfort and preference,” the researchers said. “The most common reason for interruption of prone positioning was patient request, which might have been related to overall subjective improvement or related to discomfort from prone positioning.”

Click for a Reuters graphic https://tmsnrt.rs/3c7R3Bl on vaccines in development.

© Reuters. FILE PHOTO: People wearing protective face masks walk amid concerns over the new coronavirus disease (COVID-19) in Pyongyang, North Korea May 15, 2020, in this photo released by Kyodo. Mandatory credit Kyodo/via REUTERS/File Photo

By SungHyuk An and Heejung Jung

SEOUL (Reuters) – Standing tall in bright red hazmat suits, five North Korean health workers stride towards an ambulance to do battle with a COVID-19 outbreak that – in the presumed absence of vaccines – the country is using antibiotics and home remedies to treat.

The isolated state is one of only two countries yet to begin a vaccination campaign and, until last week, had insisted it was COVID-free.

Now it is mobilizing forces including the army and a public information campaign to combat what authorities have acknowledged is an “explosive” outbreak.

In an interview on state television on Monday, Vice Minister of Public Health Kim Hyong Hun said the country had switched from a quarantine to a treatment system to handle the hundreds of thousands of suspected “fever” cases reported each day.

The broadcaster showed footage of the hazmat team, and masked workers opening windows, cleaning desks and machines and spraying disinfectant.

To treat COVID and its symptoms, state media have encouraged patients to use painkillers and fever reducers such as ibuprofen, and amoxicillin and other antibiotics – which do not fight viruses but are sometimes prescribed for secondary bacterial infections.

While previously playing down vaccines as “no panacea”, media have also recommended gargling salt water, or drinking lonicera japonica tea or willow leaf tea three times a day.

“Traditional treatments are the best!” one woman told state broadcasters as her husband described having their children gargle with salted water every morning and night.

An elderly Pyongyang resident said she had been helped by ginger tea and ventilating her room.

“I was first scared by COVID, but after following the doctors’ advice and getting the proper treatments, it turned out not a big deal,” she said in a televised interview.

‘LACK OF UNDERSTANDING’

The country’s leader, Kim Jong Un, said on Sunday – when state news agency KCNA reported 392,920 more cases of fever and eight more deaths – that drugs reserves were not reaching people, and ordered the army medical corps to help stabilize supplies in Pyongyang, where the outbreak appears to be centred.

KCNA said the cumulative tally of the fever-stricken stood at 1,213,550, with 50 deaths. It did not say how many suspected infections had tested positive for COVID.

Authorities say a large proportion of the deaths have been due to people “careless in taking drugs due to the lack of knowledge and understanding” of the Omicron variant and the correct method for treating it.

The World Health Organization has shipped some health kits and other supplies to North Korea, but has not said what drugs they contain. Neighbours China and South Korea have offered to send aid if Pyongyang requests it.

While not claiming that antibiotics and home remedies will eliminate COVID, North Korea has a long history of developing scientifically unproven treatments, including an injection made from ginseng grown in rare earth elements it claimed could cure everything from AIDS to impotence.

Some have roots in traditional medicines, while others have been developed to offset a lack of modern drugs or as “made in North Korea” exports.

Despite a high number of trained doctors and experience mobilizing for health emergencies, North Korea’s medical system is woefully under-resourced, experts say.

In a March report, an independent U.N. human rights investigator said it was plagued by “under-investment in infrastructure, medical personnel, equipment and medicine, irregular power supplies and inadequate water and sanitation facilities”.

Kim Myeong-Hee, 40, who left the North for South Korea in 2003, said such shortcomings led many North Koreans to rely on home remedies.

“Even if we go to the hospital, there are actually no medicines. There was also no electricity so medical equipment could not be used,” she said.

When she contracted acute hepatitis, she said she was told to take minari – a water parsley made famous by the 2020 film of the same name – every day, and to eat earthworms when afflicted by another, unknown illness.

Home remedies had sometimes failed to prevent loss of life during epidemics in the 1990s, Kim added.