S. Fla. restaurants, casinos reopen as governor vows no more COVID-19 shutdowns

Some coronavirus restrictions started easing up Monday in parts of South Florida.

In Miami-Dade County, restaurants were allowed to welcome back diners to indoor seating for the first time in almost two months, provided masks were worn and the establishments operated at 50% capacity.

In Palm Beach County, officials issued an order allowing tattoo and body piercing parlors, as well as tanning salons, to reopen starting Monday.

In Miami-Dade County, most indoor dining has been banned in the county since early July to stop the spread of the coronavirus.

“This does not mean this is over by a long shot,” Mayor Carlos Gimenez said in an online news conference. “While we’re heading in the right direction, we’re not out of the woods.”

The loosening up of restrictions in South Florida comes after Florida Gov. Ron DeSantis said he was considering allowing South Florida to move into Phase 2 , which would allow more businesses to resume operations.

DeSantis reiterated that idea Monday at a news conference in The Villages retirement community, saying he’s looking at reopening bars and nightclubs and wants the three South Florida counties – Palm Beach, Broward and Miami-Dade – to join the rest of the state in reopening businesses.

“Everything’s open except the nightclubs and the pubs, and that’s something we’re going to address,” DeSantis said. “We’re going to work on our three southern Florida counties, getting them where we are. And that’s really the last piece of the puzzle.”

DeSantis vowed never to have another lockdown in Florida. “I hear people say they’ll shut down the country, and, honestly, I cringe,” he said.

https://www.usatoday.com/story/travel/news/2020/09/01/coronavirus-florida-desantis-vows-never-lock-down-state-again/3454055001/

Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

Cristina Avendano-Sola, Antonio Ramos-Martinez, Elena Munez-Rubio, Belen Ruiz-Antoran, Rosa Malo de Molina, Ferran Torres, Ana Fernandez-Cruz, Alejandro Callejas-Diaz, Jorge Calderon, Concepcion Payares-Herrera, Isabel Salcedo, Irene Romera, Jaime Lora-Tamayo, Mikel Mancheno-Losa, Maria Liz Paciello, Carolina Villegas, Vicente Estrada, Isabel Saez-Serrano, Maria Lourdes Porras-Leal, Maria del Castillo Jarilla-Fernandez, Jose Ramon Pano-Pardo, Jose Antonio Moreno-Chulilla, Itziar Arrieta-Aldea, Alba Bosch, Moncef Belhassen-Garcia, Olga Lopez-Villar, Ascension Ramos-Garrido, Lydia Blanco, Maria Elena Madrigal, Enric Contreras, Eduard Muniz-Diaz, Jose Maria Domingo-Morera, Inmaculada Casas-Flecha, Mayte Perez-Olmeda, Javier Garcia-Perez, Jose Alcami, Jose Luis Bueno, Rafael F Duarte doi: https://doi.org/10.1101/2020.08.26.20182444

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2020.08.26.20182444v2.full.pdf

Abstract

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT04345523

Funding Statement

This research is funded by the Government of Spain, Ministry of Science and Innovation, Instituto de Salud Carlos III, grant number COV20/00072 (Royal Decree-Law 8/2020, of 17 March, on urgent extraordinary measures to deal with the economic and social impact of COVID-19), co-financed by the European Regional Development Fund (FEDER) A way to make Europe.

https://www.medrxiv.org/content/10.1101/2020.08.26.20182444v2

Boston Pharmaceuticals Licenses Potential NASH Treatment from Novartis

Two years after nabbing three novel anti-infective drug candidates from Swiss pharma giant Novartis for the treatment of antibiotic-resistant infections, Boston Pharma struck another deal, this time for a potential treatment for Non-Alcoholic Steatohepatitis (NASH).

Boston Pharmaceuticals licensed the drug candidate BOS-580, an injectable, genetically engineered variant of human FGF21. In many NASH patients, there is a deficiency in fibroblast growth factor 21 (FGF21), which can lead to the development of steatosis, inflammation, hepatocyte damage and fibrosis in the liver. With an optimized, well-tolerated dosing regimen that demonstrates significant hepatic fat reduction and reduced circulating markers of fibrosis, BOS-580 has the potential to be a best-in-class FGF21 agonist, Boston Pharmaceuticals said in its announcement this morning.

“As a complex disease with many comorbidities, NASH is an important therapeutic target without effective therapies,” Robert Armstrong, chief executive officer of Boston Pharmaceuticals, said in a statement. “Novartis has designed the BOS-580 product candidate with a differentiated profile. We are very pleased to build on their high-quality research to develop an innovative potential new therapy for NASH patients.”

The financial terms of the deal were not disclosed.

Although NASH, a metabolic liver disease, affects more than 16 million people in the United States alone, there has been little headway in developing a therapeutic for the disease. Multiple companies, such as Gilead Sciences, Novo Nordisk and more, have aimed their pipeline at the disease and many of them have seen clinical disappointments, including GENFIT, which scrapped its study of elafibranor in this indication in July. That followed a June the Complete Response Letter issued to Intercept Pharmaceuticals for its NASH treatment, obeticholic acid.

In May, Axcella posted positive results from a placebo-controlled non-IND study that assessed two assets in NASH and adult non-alcoholic fatty liver disease (NAFLD), AXA1125 and AXA1957. Results from the study showed that AXA1125 and AXA1957 were both well-tolerated, with sustained reductions noted for both product candidates versus placebo in key biomarkers of metabolism, inflammation and fibrosis.

If untreated, NASH patients face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation Also, they are at a significantly higher risk of liver-related mortality. Current treatment standards for NASH are lifestyle changes, including diet, weight loss and exercise. Because of the lack of approved treatments for NASH it has become a wildly popular target for companies. There are nearly 200 experimental treatments in the pipeline of drugmakers. With the plethora of companies aiming resources at NASH and the increasing growth of the disease, the analytics organization GlobalData has speculated the NASH market will hit $18.3 billion by 2026.

https://www.biospace.com/article/boston-pharmaceuticals-licenses-fourth-asset-from-novartis-a-potential-treatment-for-nash/

New York, California may have already achieved herd immunity: data scientist

Ben-Gurion University of the Negev (BGU) data scientist Prof. Mark Last sees the end of the coronavirus peak in Israel and believes that New York and California may have reached herd immunity.

Prof. Last of the BGU Department of Software and Information Systems Engineering, presented these finding virtually at the Artificial Intelligence and the Coronavirus workshop at the International Conference on Artificial Intelligence in Medicine (AIME) on August 26. He has been analyzing health data for the past 20 years.

The findings are based on the SIR Model of Infection Dynamics, which is being used to determine COVID-19 scenarios. In this model, the population is assigned to compartments with labels: S, I or R (Susceptible, Infectious or Recovered). Such models can show how different public health interventions may affect the spread of the epidemic, such as the most efficient technique for issuing a limited number of vaccines in a given population.

In late June, New York State was close to reaching herd immunity, according to the SIR model, which is defined by a disease reproduction number of less than one. Considering a steady decrease in reported mortality rates since then, the basic reproduction number under the current social distancing restrictions was 1.14. The basic reproduction number is the average amount of secondary infections an infected person will cause in a completely susceptible population.

At that time, New York had approximately 400,000 confirmed cases, implying 2.4 million (6x more) actual infections based on the results of serological tests conducted in the state.

Prof. Last says that these are similar to his estimates for California and Israel.

“In California, it appears that herd immunity was reached around July 15 with slightly more than 10% of their population (4.05 million) being infected,” he says. “This means that their basic reproduction number R0 under current restrictions is only 1.1.

“In Israel, a further lockdown is not necessary if the current restrictions are maintained and there are no unusual spreading events,” Last says. “If we maintain the current restrictions, then my model predicts that we are at the end of this peak, which should tail off at the end of August or the beginning of September. Moreover, according to my calculations, we need 1.16 million people with antibodies in order to achieve herd immunity and we are very close to that number,” he says.

“If there is no unusual outbreak because of the return to school or mass indoor gatherings, then the infection rate will start dropping. While another lockdown would certainly reduce infection rates, there is no need at the present time since social and physical distancing is working to lower infection rates.”

However, the outlook for COVID-19 patients admitted to intensive care units in Israel for COVID-19 is dire, with an estimated 80% mortality rate, according to Prof. Last’s calculations. According to the World Health Organization, the global percentage is currently about 60%. In previous research unconnected to COVID-19, Last revealed that there is an average 20% mortality among all patients admitted to ICUs.

Prof. Last’s model is based on the COVID-19 attributed deaths reported by the Israeli Ministry of Health on a daily basis and an estimation of the total number of infected people based on published results of serological tests rather than just on confirmed cases.

“We cannot know the actual number of cases of infection unless we test the entire population every day. Initial serological tests conducted in Israel indicate the ratio of confirmed cases to actual cases is about 1:10. Using those numbers, we now have slightly above one million people with antibodies in Israel and we need at least 1.2 million,” he says.

Therefore, he is cautiously optimistic about the COVID-19 epidemic in Israel. “We are heading in the right direction, but it is important not to relax our restrictions or get overconfident,” he warns.

https://medicalxpress.com/news/2020-09-york-california-herd-immunity-scientist.html

First randomised trial backs safety of common heart drugs in COVID-19

Heart patients hospitalized with COVID-19 can safely continue taking angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), according to the BRACE CORONA trial presented in a Hot Line session today at ESC Congress 2020.

ACE inhibitors and ARBs are commonly taken by heart patients to reduce blood pressure and to treat heart failure. There is conflicting observational evidence about the potential clinical impact of ACE inhibitors and ARBs on patients with COVID-19. Select preclinical investigations have raised concerns about their safety in patients with COVID-19. Preliminary data hypothesize that renin-angiotensin-aldosterone system (RAAS) inhibitors could benefit patients with COVID-19 by decreasing acute lung damage and preventing angiotensin-II-mediated pulmonary inflammation.

Given the frequent use of these agents worldwide, randomized clinical trial evidence is urgently needed to guide the management of patients with COVID-19.

Membrane-bound angiotensin-converting enzyme 2 (ACE2) is the functional receptor for SARS-CoV-2, the virus responsible for the coronavirus disease 2019 (COVID-19). ACE2 expression may increase due to upregulation in patients using ACE inhibitors and ARBs.

The BRACE CORONA trial was an academic-led, phase 4, randomized study testing two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days versus continuing ACE inhibitors/ARBs in patients who were taking these medications chronically and were hospitalized with a confirmed diagnosis of COVID-19. The primary outcome was the number of days alive and out of hospital at 30 days.

Patients who were using more than three antihypertensive drugs, or sacubitril/valsartan, or who were haemodynamically unstable at presentation were excluded from the study.

The trial enrolled 659 patients from 29 sites in Brazil. All participants were chronically using an ACE inhibitor or ARB and were hospitalized with COVID-19. Patients were randomly allocated to stopping the ACE inhibitor/ARB for 30 days or continuing the ACE inhibitor/ARB.

The average number of days alive and out of hospital was 21.9 days for patients who stopped ACE inhibitors/ARBs and 22.9 days for patients who continued these medications. The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% confidence interval [CI] 0.90 to 1.01, p=0.09). The average difference between groups was -1.1 days (95% CI -2.33 to 0.17).

The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group. A similar 30-day mortality rate was seen for patients who continued and suspended the ACE inhibitor/ARB (2.8% versus 2.7%, respectively with a hazard ratio of 0.97).

“This is the first randomized data assessing the role of continuing versus stopping ACE inhibitors and ARBs in patients with COVID-19,” said principal investigator Professor Renato Lopes of Duke Clinical Research Institute, Durham, US. “In patients hospitalized with COVID-19, suspending ACE inhibitors and ARBs for 30 days did not impact the number of days alive and out of hospital.”

He concluded: “Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication.”

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More information: Abstract title: Continuing versus suspending ACE inhibitors and ARBs: Impact of adverse outcomes in hospitalized patients with COVID-19—The BRACE CORONA Trial.

https://medicalxpress.com/news/2020-09-randomised-trial-safety-common-heart.html

Trump says he will meet with drugmakers this week over pricing

President Donald Trump said on Tuesday he planned to meet with pharmaceutical companies this week regarding his so-called most- favored-nation executive order aimed at lowering drug prices paid by the U.S. federal government.

The president signed the executive order this summer which, among other things, would require Medicare to tie the prices it pays for drugs to those paid by other countries. Its implementation, however, has been delayed as the administration seeks to work out a solution with the industry.

The Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceutical industry trade group that has worked closely with the Trump administration on drug pricing issues, is not aware of a meeting scheduled for this week, spokeswoman Nicole Longo said.

Trump said the drugmakers had a “real problem” with his decision.

“So, they’re coming in to see me, and we expect to get a very substantial price reduction in prescription drugs, which has never been done before,” Trump told reporters at Joint Base Andrews as he departed for Wisconsin. “They’re coming … this week.”

Under the rule, the Medicare insurance program would only pay a price for a drug that matches the lowest price paid among foreign governments. Medicare, which covers older Americans and those with disabilities, is currently prohibited from negotiating the prices it pays to drugmakers.

https://www.reuters.com/article/us-usa-trump-drugprices/trump-says-he-will-meet-with-drugmakers-this-week-over-pricing-idUSKBN25S5KG

CDC issues order to temporarily halt residential evictions September 1, 2020

The U.S. Centers for Disease Control and Prevention on Tuesday issued an order temporarily halting residential evictions on public health grounds.

The order lasts through Dec. 31 and applies to individual renters earning no more than $99,000 in annual income. The CDC said an eviction moratorium “can be an effective public health measure utilized to prevent the spread of communicable disease” like COVID-19.

Renters still owe rent and the order does not prevent the “charging or collecting of fees, penalties, or interest as a result of the failure to pay rent or other housing payment on a timely basis,” the CDC said.

U.S. Treasury Secretary Steven Mnuchin told a U.S. House of Representatives panel earlier the measure was to ensure people “don’t get thrown out of their rental homes” as a result of the coronavirus pandemic.

Mnuchin said the actions affect about 40 million renters. He said Congress should still approve rental assistance.

In July, a firm estimated more than $21.5 billion in past-due rent is owed by Americans.

Over the spring and early summer, as unemployment surged to levels unseen since the aftermath of the 1930s Great Depression, a patchwork of federal, state and local eviction bans kept renters who could not make payments in homes.

The Democratic-controlled House of Representatives passed a bill in May that would extend enhanced jobless aid through January and allocated $100 billion for rental assistance. It would also have extended the federal ban on evictions for up to one year. The bill has not been approved in the Senate.

https://www.reuters.com/article/us-health-coronavirus-usa-renters/u-s-cdc-issues-order-to-temporarily-halt-residential-evictions-idUSKBN25S620