September 1 coronavirus news

Students walk through the campus at the University of Arizona in Tucson, Arizona, on August 24.

Schools are reopening – and the virus is spreading across US college campuses.

At least 37 states are reporting positive Covid-19 cases at colleges or universities, making a total of more than 25,000 cases among students and campus staff.

The states are:

Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington and Wisconsin.

Lenzilumab, an antibody therapy, reduced the relative risk of death or need for ventilation by 80% for Covid-19 patients, according to a new study.

California-based biopharmaceutical company Humanigen said Tuesday it has been evaluating the drug in an ongoing late stage drug trial. 

How the study was conducted: It involved 39 patients who had risk factors for poor outcomes and Covid-19 pneumonia. Twelve were treated with the antibody therapy, and the remaining 27 received standard care.

How the two groups compared: Patients who received the antibody therapy saw signs of significant improvement in inflammatory markers, and were discharged from hospital in a median of five days – compared to 11 days for those who got standard care.

Patients who got the therapy had an 8% risk of death or needing a ventilator, compared to 41% for the standard care group.

The antibody therapy patients took one day (on median) to recover from the cytokine storm – which is when the body’s overactive immune response begins to attack its own cells rather than just the virus. For the standard care group, that median recovery time was eight days.

What is the therapy? Lenzilumab is a monoclonal antibody – a lab engineered version of an immune system molecule that attacks a single target.

It was originally developed to treat certain forms of leukemia, but because it tamps down the inflammatory response, researchers have been trying it out in coronavirus patients.

A larger randomized, placebo controlled clinical trial is underway at multiple sites across the US. The company expects the trial to be complete sometime in September. 

Gov. Larry Hogan speaks during a news conference in in Annapolis, Maryland on August, 27.

Maryland Gov. Larry Hogan said on Tuesday that the State Board of Elections had finally mailed out ballot applications to every voter in his state, after he had asked them to do so immediately nearly eight weeks ago.

He urged Maryland voters to take advantage of voting by absentee ballot, to participate in early voting, or to vote at off-peak times on Election Day to reduce crowds at the polls amid the coronavirus pandemic.

“I’m still concerned about whether or not they’re going to be able to pull it off,” Hogan said, concerning the efforts of the Maryland State Board of Elections, adding that he had urged the board to open more polling places, which they did.

Maryland reopening: At the same news conference on Tuesday, Hogan also announced that the state would begin to move into stage 3 of its reopening plan after seeing improving health metrics.

The phased reopening includes opening outdoor performance venues, indoor theaters, and retail and religious facilities – all with varying caps on the maximum number of people allowed inside.

There are now 30 coronavirus cases in Canada linked to Bar Le Kirouac, a karaoke bar in Quebec City, according to the province’s regional public health department.

“We are in the process of figuring out with public security whether this is a criminal matter,” Quebec Health Minister Christian Dubé said during a news conference on Tuesday. 

Dubé said Quebec is considering imposing fines in the case.

“We are talking about karaoke, where people who think that because they are with friends, they know well that they can relax, take off the mask, pass the microphone, get close to each other to sing together. These are enjoyable things, but we can’t do that anymore,” the minister added.

The United States has reported 42,284 new Covid-19 cases and 1,032 virus-related deaths so far on Tuesday, according to data from Johns Hopkins University.

That raises the national total to at least 6,072,871 cases and 184,629 deaths.

The totals include cases from all 50 states, the District of Columbia and other US territories, as well as repatriated cases. 

Follow our live tracker of US cases:

Colombia’s coronavirus lockdown was partially lifted on Tuesday, even as the country reported 389 new coronavirus deaths, taking the death toll there to 20,052.

The Health Ministry also reported 8,901 new cases of Covid-19 on Tuesday, Colombia’s sixth consecutive day reporting fewer than 10,000 new infections. In total, Colombia has reported 624,069 cases of coronavirus.

Only Brazil and Peru lead Colombia in terms of the highest numbers of coronavirus infections in Latin America, according to data from Johns Hopkins University.

Starting Tuesday, restrictions on activities such as air travel, intercity transport and non-essential businesses were partially lifted in Colombia.

Bars and restaurants are to remain closed until at least the end of September, with limited exceptions allowing for open-air dining.

The US Food and Drug Administration issued a warning letter to a Montana-based company for selling an amniotic fluid product as a coronavirus treatment and for advertising for a nonexistent Covid-19 study.

Lattice Biologics, Ltd. was warned after federal regulators investigated its website and social media sites and learned the company was selling a product called AmnioBoost, a stem cell product that it touted as a treatment for lung damage from Covid-19, the FDA said in a news release.

The FDA cited a YouTube video posted on April 2 that the company made called “Stem Cells For Covid-19” where the CEO of Lattice Biologics injects himself with what he says are 1 million stem cells to test safety and efficacy of the amniotic fluid product.

It quoted the post verbatim. “The YouTube video marketing your amniotic fluid product, in which you state that you ‘hop[e] that the stem cells can go in and repair’ [severe lung damage] … even if you are at the hospital … you have this lung damage this is a reasonable treatment to try and repair that,” it said.

“We request that you take immediate action to cease marketing such unlicensed, unapproved, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of SARS or ARDS related to COVID-19,” the agency wrote in the warning letter.

The FDA also warned the company about its recruitment efforts for a “free clinical trial” of its amniotic product looking for Covid-19 patients with “a laboratory confirmed infection with COVID-19 and evidence of lung involvement requiring supplemental oxygen or mechanical ventilation” to be administered “5 million [stem cells] on the first day of enrollment and will receive another 5 million stem cells on the second day of enrollment.”

“We advise you to review your website, social media websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product as safe and effective for a COVID-19-related use for which it has not been licensed by FDA and that you do not make claims that misbrand the product in violation of the FD&C Act,” the regulator said.

The company has 48 hours to respond or face potential legal action.

There are no FDA-approved products to prevent, treat or cure Covid-19, although the FDA has granted emergency use authorization to very few therapies.

Maryland Gov. Larry Hogan

Maryland Gov. Larry Hogan today announced that Maryland will begin to move into stage three of the “Maryland Strong: Roadmap to Recovery,” with additional gradual reopenings starting Friday.

As part of the state’s initial entry into this stage, indoor theaters for live performances or movies, will be allowed to reopen to the general public at 50% capacity, or 100 people per auditorium, whichever is less, along with appropriate health and safety protocols, a release from Hogan’s office said.

Outdoor venues for live performances and outdoor movie theaters will also be able to reopen to the general public at 50% capacity, or 250 people, whichever is less, Hogan said.

Capacity for retail establishments and religious facilities will be allowed to increase from 50 to 75%, according to the release.

In an extraordinary move, the Centers for Disease Control and Prevention is moving to temporarily halt most evictions for Americans struggling to pay their rent due to the pandemic, in a step that’s broader than eviction protections already in place.

But senior administration officials say renters will have to prove a number of things before qualifying, and will still have to pay back any missed rent payments.

The move comes after negotiations on further coronavirus aid have been stalled on Capitol Hill as Republicans and Democrats refuse to budge on topline numbers for what a new relief package would cost.

In a phone call with reporters on Tuesday, officials, speaking on background, said the order will apply to Americans who qualified for direct payments under the CARES Act.

People will also have to prove that they’ve taken “best efforts possible to seek government assistance to make their rental payments,” they will have to “declare that they are unable to pay rent due to Covid financial hardship,” and must show they “will likely become homeless or move into congregate housing settings if they are evicted.”

Landlords will still be able to remove tenants for “committing criminal acts, threatening the health and safety of other residents, damaging property or other health and safety considerations,” an official added.

Renters will have to fill out several forms, found on the CDC’s website, and give them directly to their landlords to qualify for the program.

“This will be a declaration presented to the landlord, if that landlord approaches a tenant with an intent to evict,” an official said. Because the move is federally mandated, it “would become a criminal offence” if the landlord chose to ignore the declaration. But it could still end up in courts, possibly leading to legal actions that could show up on background checks or credit reports.

“To the extent that there is a dispute between the landlord and the renter about whether or not an eviction protection is in place here, it can be filed, and that would be for the local courts, which are not federal to adjudicate,” an official said.

Officials did not answer questions about how that legal action could impact credit or future housing options. 

Under the CARES Act, only renters in federally-backed rental units were protected from eviction. “This covers any rental unit in United States, so long as the renter meets those requirements, where they’ve demonstrated that they are at risk of becoming evicted,” an official said. There’s also currently a moratorium on evictions for federally-backed, single family home mortgages.

But, “it is not an invitation to stop paying rent,” another official cautioned. “The order makes clear that a renter who cannot pay his or her full rent should pay an amount that is not unduly burdensome, and as close to payment as possible.”

“We want to be clear that those who benefit from this assistance, are still obligated to pay any accrued rent or housing payments in accordance with their lease or contract,” a senior administration official said.

As for why the move is being made by the CDC, an official says “the CDC director has authority to take measures that he’s reasonably necessary to mitigate the spread of communicable disease.”

Asked why that authority wasn’t being used to enact a federal mask mandate, officials refused to answer because the question didn’t “have to do with the call at hand.”

Deputy press secretary Brian Morgenstern said the action “means that people struggling to pay rent due to the coronavirus will not have to worry about being evicted and risk further spreading of or exposure to the disease due to economic hardship,” and attacked Democrats on the hill.

Researchers are learning more about what pregnant women may experience if they are infected with the coronavirus that causes Covid-19. 

Pregnant and recently pregnant women who are diagnosed with Covid-19 in the hospital appear to be less likely to have symptoms of fever and muscle pain but more likely to be admitted to the intensive care unit, according to a new paper published in the BMJ medical journal on Tuesday. 

The study also found pregnant women with Covid-19 are at increased risk of delivering preterm, but preterm birth rates were not high, and more study is needed.

  “We found that one in 10 pregnant or recently pregnant women who are attending or admitted to hospital for any reason are diagnosed as having suspected or confirmed covid-19, although the rates vary,” the researchers — from various institutions in Europe and China — wrote in the paper. 

More on the study: The researchers reviewed 77 studies on Covid-19 in pregnant and recently pregnant women, published from Dec. 1 and June 26. 

Collectively, those studies included data on 13,118 pregnant and recently pregnant women with Covid-19, and 83,486 non-pregnant women of reproductive age who also had Covid-19. 

“The covid-19 related symptoms of fever and myalgia manifest less often in pregnant and recently pregnant women than in nonpregnant women of reproductive age,” the researchers wrote.

“Pregnant or recently pregnant women with covid-19 seem to be at increased risk of requiring admission to an intensive care unit or invasive ventilation,” they wrote. “Increased maternal age, high body mass index, and pre-existing comorbidities might be associated with severe disease.”

The researchers also found in those studies that pregnant women with Covid-19 are at increased risk of delivering preterm and their babies being admitted to the neonatal unit, although overall rates of spontaneous preterm births were not high. Also, stillbirth and neonatal death rates were low, the researchers found. 

Limitations of the study: The paper had some limitations, including that the studies used in the review primarily reported on pregnant women who required visits to the hospital and not many studies reported outcomes by trimester. 

 “Reviews such as this can only be as good as the studies they summarise and it is important to note that a high proportion of the included studies have a substantial risk of bias,” Dr. Marian Knight, professor of maternal and child population health at the University of Oxford in the United Kingdom, said in a statement distributed by the UK-based Science Media Centre on Tuesday. 

 “It is also important to recognise that, whilst this review reports high preterm birth rates, a number of women affected by COVID-19 in pregnancy are still pregnant, and thus are not included in the study data. This may make preterm birth rates appear artificially high,” Knight said in part. “Nevertheless, some pregnant women affected by COVID-19 may have a subsequent preterm birth and preventing infection remains essential.”