COVID-19

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have established new criteria to classify variants of SARS-CoV-2, the virus that causes COVID-19.

The criteria are meant to clarify how much is known about recent changes to the circulating viruses. The levels also help convey risk.

The new designations are “variant of interest”; “variant of concern”; and “variant of high consequence.”

A variant of interest has caused discrete clusters of infections in the United States or in other countries or seems to be driving a surge in cases. It also has gene changes that suggest it might be more contagious or that may help it to escape immunity conferred by natural infection or vaccination. Therapeutics and tests may not work as well against it. The CDC is watching three of these.

A variant of concern has been proven through scientific research to be more contagious or to cause more severe disease. It may also reduce the effectiveness of therapeutics and vaccines. People who have previously had COVID-19 may become reinfected by the new strain. The CDC is tracking five of these.

A variant of high consequence causes more severe disease and greater numbers of hospitalizations. It has also been shown to defeat medical countermeasures, such as vaccines, antiviral drugs, and monoclonal antibodies. So far, none of the variants meets this definition.

Source: CDC.gov

The US FDA has issued guidance warning consumers against using the antiparasitic drug ivermectin to treat or prevent COVID-19.

The agency issued the guidance in light of growing interest in the drug as a COVID-19 treatment and multiple reports of patients hospitalized or needing medical support “after self-medicating with ivermectin intended for horses.”

Ivermectin, which is not an antiviral, has not been approved by the FDA for treating or preventing COVID-19, the guidance emphasized.

“Using any treatment for COVID-19 that’s not approved or authorized by the FDA, unless part of a clinical trial, can cause serious harm,” the FDA says.

Ivermectin tablets are FDA-approved to treat two conditions caused by parasitic worms: intestinal strongyloidiasis and onchocerciasis (river blindness). Some topical applications of ivermectin are approved to treat head lice and skin conditions such as rosacea.

Some forms of ivermectin are used to prevent heartworm disease in animals, as well as certain internal and external parasites.

The FDA says, “It’s important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only.”

The guidance points out that the concentrations of ivermectin for cows and horses can be highly toxic to humans.

“If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed,” the guidance says. “Taking large doses of this drug is dangerous and can cause serious harm.”

Adverse Effects
Interactions with other drugs, such as blood thinners, are also potentially dangerous even at the levels specified in approved uses, the FDA says.

“You can also overdose on ivermectin,” the FDA warns, adding that ivermectin can cause nausea, vomiting, diarrhea, hypotension, allergic reactions, dizziness, ataxia, seizures, coma, and even death.

The FDA has not reviewed data to support use of ivermectin to treat or prevent COVID-19, but research is beginning.

An article published on Thursday in JAMA found that ivermectin, tested in a randomized trial of 476 patients, did not significantly shorten duration of symptoms for adults with mild COVID-19 who received a 5-day course of ivermectin compared with placebo (median time to resolution of symptoms, 10 vs 12 days; hazard ratio for resolution of symptoms, 1.07).

As for adverse effects, the most commonly reported in the JAMA study was headache, reported by 104 patients (52%) in the ivermectin group and 111 (56%) in the placebo group. The most common serious adverse event was multiorgan failure, which occurred in four patients (two in each group).

“The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes,” the authors write.

Excitement about the drug has grown after some smaller studies have shown positive results for the drug related to COVID-19.

However, the National Institutes of Health (NIH) says, “[M]ost of these studies had incomplete information and significant methodological limitations.”

The NIH’s COVID-19 Treatment Guidelines, in guidance last updated February 11, said there is insufficient evidence to recommend either for or against the use of ivermectin for the treatment of COVID-19.

That recommendation was upgraded from guidance in August that recommend against ivermectin’s use in treating or preventing COVID-19, as Medscape Medical News has reported.

“Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19,” the NIH panel writes.

Source: FDA

A single pill of the investigational drug molnupiravir taken twice a day for 5 days eliminated SARS-CoV-2 from the nasopharynx of 49 participants. Preclinical studies suggest that molnupiravir is effective against a number of viruses, including coronaviruses and specifically SARS-CoV-2.

Mechanism: It prevents a virus from replicating by inducing viral error catastrophe — essentially overloading the virus with replication and mutation until the virus burns itself out and can’t produce replicable copies.

In this phase 2a, randomized, double-blind control trial, researchers recruited 202 adults who were treated at an outpatient clinic with fever or other symptoms of a respiratory virus and confirmed SARS-CoV-2 infection by day 4. Participants were randomly assigned to three different groups: 200 mg of molnupiravir, 400 mg; or 800 mg. The 200 mg arm was matched one-to-one with a placebo-controlled group, and the other two groups had three participants in the active group for every one control.

Participants took the pills twice daily for 5 days, and then were followed for a total of 28 days to monitor for complications or adverse events. At days 3, 5, 7, 14, and 28, researchers also took nasopharyngeal swabs for PCR tests, to sequence the virus, and to grow cultures of SARS-CoV-2 to see if the virus that’s present is actually capable of infecting others.

Source: Medscape

“After more than a year since the coronavirus disease 2019 (COVID-19) outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention continue to underscore that there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19,” said the statement attributed to Janet Woodcock, MD, acting commissioner of food and drugs at the U.S. Food and Drug Administration.

The statement noted that COVID-19 is a respiratory illness spread from person to person. Some researchers found small amounts of virus particles on food or food packaging, but the infection usually requires a much higher number of particles, the statement said.

Source: FDA

FDA approves emergency use of Saliva Test to detect COVID-19

Rutgers University-based RUCDR Infinite Biologics developed a saliva collection method in partnership with Spectrum Solutions and Accurate Diagnostic Labs.

The document states that the collection of saliva specimens is limited to patients with symptoms of COVID-19 and should be performed in a health care setting under the supervision of a trained health care clinician. Samples are transported for RNA extraction and are tested within 48 hours of collection. In saliva samples obtained from 60 patients evaluated by the researchers, all were in agreement with the presence of COVID-19.

Source: Medscape

Source: Medscape

Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months.

How are vaccines tested?

• In the pre-clinical stage of testing, researchers give the vaccine to animals to see if it triggers an immune response.
• In phase 1 of clinical testing, the vaccine is given to a small group of people to determine whether it is safe and to learn more about the immune response it provokes.
• In phase 2, the vaccine is given to hundreds of people so scientists can learn more about its safety and correct dosage.
• In phase 3, the vaccine is given to thousands of people to confirm its safety – including rare side effects – and effectiveness. These trials involve a control group which is given a placebo.

Vaccines in clinical trials

• Sinovac: Chinese company Sinovac is developing a vaccine based on inactivated Covid-19 particles. The vaccine has shown a promising safety profile in the early stages of testing and is now moving into Phase 3 trials in Brazil.
• The Murdoch Children’s Research Institute in Australia is conducting a phase 3 trial using a nearly 100-year-old tuberculosis vaccine. The vaccine is not thought to protect directly against Covid-19 but might boost the body’s non-specific immune response.
• University of Oxford/AstraZeneca: The University of Oxford vaccine is delivered via a chimpanzee virus, called the vaccine vector. The vector contains the genetic code of the protein spikes found on the coronavirus and triggers a strong immune response in the human body. The vaccine is in a combined phase 2/3 trial in the UK and has recently gone into phase 3 trials in South Africa and Brazil.
  CanSino Biologics Inc./Beijing Institute of Biotechnology
  The vaccine developed by Chinese company CanSino Biologics and the Beijing Institute of Biotechnology – a university close to the Chinese military – reportedly showed promising results in phase 2 testing, although no data from the trial has been published. In a world first, the vaccine has now been approved for military use, but it is unclear how broadly it will be distributed.
• Moderna/NIAID: American biotech company Moderna is developing a vaccine candidate using messenger RNA (or mRNA for short) to trick the body into producing viral proteins itself. No mRNA vaccine has ever been approved for an infectious disease, and Moderna has never brought a product to market. But proponents of the vaccine say it could be easier to mass produce than traditional vaccines.
• Inovio Pharmaceuticals/ International Vaccine Institute
• Cadila Healthcare Limited
• Wuhan Institute of Biological Products/Sinopharm
• Beijing Institute of Biological Products/Sinopharm
• Novavax
• BioNTech/Fosun Pharma/Pfizer
• Genexine Consortium
• Osaka University/ AnGes/ Takara Bio
• Institute of Medical Biology, Chinese Academy of Medical Sciences
• Gamaleya Research Institute
• Clover Biopharmaceuticals Inc./GSK/Dynavax
• Anhui Zhifei Longcom Biopharmaceutical/ Institute of Microbiology,
• Chinese Academy of Sciences
• Vaxine Pty Ltd/Medytox
• Imperial College London
• Curevac
• People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech.
• Medicago Inc./ Université Laval
• University of Melbourne/Murdoch Children’s Research Institute

Draft landscape of COVID-19 candidate vaccines by WHO: Download PDF ›

Source: WHO

Observed COVID-19 associated skin patterns were:

• Acral erythema with vesicles or pustules; so-called “pseudo-chilblains”  or “COVID Toes” (19%)
• Vesicular (chicken pox-like) eruptions (9%)
• Maculopapular eruptions (47%)
• Urticaria (19%)
• Livedo or necrosis (6%)

1. Acral areas of erythema-oedema with some vesicles or pustules (pseudo-chilblain) (19% of cases).

These lesions, affecting hands and feet, may resemble chilblains (small, itchy swellings on the skin) with small red or purple spots, caused by bleeding under the skin. They were usually asymmetrical.

Associated with: younger patients, lasted for a mean of 12.7 days, took place later in the course of the COVID-19 disease and was associated with less severe disease (in terms of hospital admission, pneumonia, intensive care unit admission or mortality). They could cause pain (32%) or itch (30%).

2. Other vesicular eruptions (9%).

Vesicular eruptions are outbreaks of small blisters, some of these presented on the trunk. They may also affect the limbs, may be filled with blood, and become larger or more spread out.

Associated with: middle aged patients, lasted for a mean of 10.4 days, appeared more commonly (15%) before other symptoms and were associated with intermediate severity. Itching was common (68%).

3. Urticarial lesions (19%):

These consist of pink or white raised areas of skin resembling nettle rash, known as wheals (also spelled weals), which are usually itchy. Mostly distributed in the trunk or spread across the body. A few cases were on the palms of the hands. Associated with: see below ‘4. Other maculopapules’

4. Other maculopapules (47%).

Maculopapules are small, flat and raised red bumps. In some cases these were distributed around hair follicles, there was also varying degrees of scaling. Some had been described as similar to pityriasis rosea, a common skin condition. Blood spots under the skin may also be present, either in the form of spots/dots or on larger areas.

Associated with: lasting for a shorter period (6.8 days mean for urticarial and 8.6 for maculopapular), usually appeared at the same time than the rest of the symptoms and were associated with more severe COVID-19 disease (2% mortality in the sample). Itching was very common for urticariform lesions (92%) and 57% for maulopapular.

5. Livedo or necrosis (6%).

Livedo is a skin condition where circulation in the blood vessels of the skin is impaired. It causes the skin to take on a blotchy red or blue appearance with a retiform (net-like) pattern. Necrosis refers to the premature death of skin tissue. These patients showed different degrees of lesions suggesting occlusive vascular disease, where a narrowing or blocking of arteries occurs, limiting blood flow to certain areas of the body (in this case the trunk or extremities).

Associated with: older patients with more severe disease (10% mortality). However, the manifestations of COVID-19 in this group were more variable, including transient livedo, with some suffering COVID-19 that did not require hospitalisation.

Source: Medscape, skinhealthinfo.org.uk

The world faces a shortage of oxygen concentrators as the number of worldwide cases of coronavirus infection nears the 10 million. COVID-19 Tracker ›

“Many countries are now experiencing difficulties obtaining oxygen concentrators,” WHO Director General Tedros Adhanom Ghebreyesus told a news conference. “Demand is currently outstripping supply.”

The sudden rise has created a dearth of oxygen concentrators needed to support breathing of COVID-19 patients suffering from respiratory distress.

The health agency has purchased 14,000 oxygen concentrators from manufacturers and plans to send them to 120 countries in coming weeks, Tedros said. A further 170,000 concentrators – valued at some $100 million – will be potentially available over the next six months.

The head of the WHO emergencies programme, Dr Mike Ryan, meanwhile said the pandemic in many Latin American countries was still intense as deaths in the region surpassed 100,000 this week. Many countries had experienced 25-50% increases in cases in the past week, he said.

Source: Reuters