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CO-RADS classification

The CO-RADS classification is a standardized reporting system for patients with suspected COVID-19 infection developed for a moderate to high prevalence setting.

CO-RADS 1

COVID-19 is highly unlikely.
The CT is normal or there are findings that indicate a non-infectious disease like congestive heart failure, sarcoid, histoplasmosis, malignancy, UIP or fibrotic NSIP (if unchanged to prior examination).
An exemption has to be made for the first few days of a mild infection when the CT can be normal.

CO-RADS 2

Level of suspicion of COVID-19 infection is low.
Findings are consistent with other infections like typical bronchiolitis with tree-in-bud and thickened bronchus walls.
No typical signs of COVID-19.

CO-RADS 3

COVID-19 unsure or indeterminate.
CT abnormalities indicating infection, but unsure whether COVID-19 is involved, like widespread bronchopneumonia, lobar pneumonia, septic emboli with ground glass opacities.

CO-RADS 4

In CO-RADS 4 the level of suspicion is high.
Mostly these are suspicious CT findings but not extremely typical:
Unilateral ground glass
Multifocal consolidations without any other typical finding
Findings are suspicious of COVID-19 in underlying pulmonary disease.

CO-RADS 5

Multifocal GGO and consolidation
PCR positive

CO-RADS 6

Patient with positive PCR and bilateral GGO.

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Sintilimab + Platinum based chemotherapy in Advanced Nonsquamous NCLC

The investigational anti-PD-1 antibody sintilimab has shown that it improves the efficacy of platinum-based chemotherapy in the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) in a Chinese phase 3 trial dubbed ORIENT-11.

Sintilimab is a fully human IgG4 monoclonal antibody that blocks the binding of programmed death (PD)-1 to PD ligand 1 (PD-L1) or PD-L2 with high affinity, and has received market authorization in China for the treatment of Hodgkin’s lymphoma.

For ORIENT-11, almost 400 patients with advanced non-squamous NSCLC were randomly assigned to sintilimab or placebo plus pemetrexed and platinum-based chemotherapy in a 2:1 ratio.

“The addition of sintilimab to pemetrexed and platinum significantly improved PFS [progression-free survival] compared to placebo,” reducing progression rates by 52%, noted lead investigator Li Zhang, MD, professor of medical oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.

Source: Medscape

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BCG vaccination may slow spread of COVID-19

Countries that had compulsory bacillus Calmette-Guérin (BCG) vaccination at least until 2000 appear to have built up a degree of “herd immunity” against COVID-19, a new study suggests.

BCG vaccination is usually given at birth or during childhood to protect against tuberculosis (TB). But there is also evidence that it protects against other respiratory infections and lung cancer. In addition, it is an effective treatment for some forms of bladder cancer.

A study in 2018 found that the vaccine appeared to “reprogram” immune cells to produce more of a particular immune signalling molecule. This, in turn, boosted immunity against viral infection. The studies found that having mandatory BCG vaccination significantly “flattened the curve” of the initial spread of COVID-19 throughout the populations studied.

Source: Medscape

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Tenofovir prophylaxis to prevent mother-to-child transmission of HBV

New recommendation: WHO recommends that pregnant women testing positive for HBV infection (HBsAg positive) with an HBV DNA ≥ 5.3 log10 IU/mL (≥ 200,000 IU/mL)1 receive tenofovir prophylaxis from the 28th week of pregnancy until at least birth, to prevent mother-to-child transmission of HBV. This is in addition to three-dose hepatitis B vaccination in all infants, including timely birth dose (conditional recommendation, moderate quality of evidence). Use of HBeAg testing, where HBV DNA testing is not available, to determine treatment eligibility for tenofovir prophylaxis to prevent mother-to-child transmission of HBV.

New recommendation: WHO recommends that in settings in which antenatal HBV DNA testing is not available, HBeAg testing can be used as an alternative to HBV DNA testing to determine eligibility for tenofovir prophylaxis to prevent mother-to-child transmission of HBV2 (conditional
recommendation, moderate quality of evidence).

Source: WHO

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Lenvatinib-Pembrolizumab combination in Advanced Gastric Cancer

The combination of the anti-PD-1 antibody pembrolizumab and the multikinase inhibitor lenvatinib provides objective response rates in many patients with advanced gastric cancer, according to results from an early single-arm trial.

Lenvatinib monotherapy was associated with durably stable disease in a phase-1 study of patients with solid tumors, and the combination of lenvatinib plus pembrolizumab has shown promising antitumor activity with manageable safety profiles for several malignancies.

Lenvatinib is a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3, and other receptor tyrosine kinases. Pembrolizumab, an antibody targeting PD-1, has also moderate efficacy in biomarker-unselected endometrial cancer.

Source: Medscape

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COVID-19 coronavirus vaccine tracker

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

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FDA approves Collagenase Clostridium Histolyticum for Cellulite

The FDA has approved collagenase clostridium histolyticum for the treatment of moderate to severe cellulite in the buttocks of adult women. The drug is the first injectable treatment for cellulite to receive regulatory approval.

Dose: 0.9mg Solution, Injection

MOA: When injected into the treatment area, It is thought to release the fibrous septae enzymatically by specifically targeting types 1 and 3 collagen, which may result in the smoothing of the skin and an improved appearance of cellulite.

Common side effects: Injection site bruising, pain, areas of hardness, itching, redness, discoloration, swelling, and warmth in the treatment area.

In cellulite, fibrous septae are a primary contributing factor. The septae make up the fibrous connective tissue that connects the skin perpendicularly to the fascia below and tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as “dimpling.”

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Cutaneous manifestations of COVID-19

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

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Triple therapy for COPD

Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single-dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking.

Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate–formoterol or budesonide–formoterol.

Case study: The modified intention-to-treat population comprised of 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg–budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg–budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate–formoterol group (2120 patients), and 1.24 in the budesonide–formoterol group (2131 patients). The rate was significantly lower with 320-μg–budesonide triple therapy than with glycopyrrolate–formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P<0.001) or budesonide–formoterol (13% lower: rate ratio, 0.87; 95% CI, 0.79 to 0.95; P=0.003). Similarly, the rate was significantly lower with 160-μg–budesonide triple therapy than with glycopyrrolate–formoterol (25% lower: rate ratio, 0.75; 95% CI, 0.69 to 0.83; P<0.001) or budesonide–formoterol (14% lower: rate ratio, 0.86; 95% CI, 0.79 to 0.95; P=0.002). The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate–formoterol group

Source: NEJM.org

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WHO warns of oxygen shortage as COVID cases set to 10 million

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