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Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19

Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19 | Virus World | Scoop.it

Summarized below are the recommendations with comments related to the clinical practice guideline for the treatment and management of COVID-19. A detailed description of background, methods, evidence summary and rationale that support each recommendation, and research needs can be found online in the full text...

 

The guideline panel used the word “only” in recommendations about therapeutic agents with higher uncertainty and/or more potential for harm. These recommendations acknowledge the current “knowledge gap” and aim at avoiding premature favorable recommendations for potentially ineffective or harmful interventions.

 

  • Recommendation 1. Among patients who have been admitted to the hospital with COVID-19, the IDSA guideline panel recommends hydroxychloroquine/chloroquine in the context of a clinical trial. (Knowledge gap)
  • Recommendation 2. Among patients who have been admitted to the hospital with COVID-19, the IDSA guideline panel recommends hydroxychloroquine/chloroquine plus azithromycin only in the context of a clinical trial. (Knowledge gap)
  • Recommendation 3. Among patients who have been admitted to the hospital with COVID-19, the IDSA guideline panel recommends the combination of lopinavir/ritonavir only in the context of a clinical trial. (Knowledge gap)
  • Recommendation 4. Among patients who have been admitted to the hospital with COVID-19 pneumonia, the IDSA guideline panel suggests against the use of corticosteroids. (Conditional recommendation, very low certainty of evidence)
  • Recommendation 5. Among patients who have been admitted to the hospital with ARDS due to COVID-19, the IDSA guideline panel recommends the use of corticosteroids in the context of a clinical trial. (Knowledge gap)
  • Recommendation 6. Among patients who have been admitted to the hospital with COVID-19, the IDSA guideline panel recommends tocilizumab only in the context of a clinical trial. (Knowledge gap)
  • Recommendation 7. Among patients who have been admitted to the hospital with COVID-19, the IDSA guideline panel recommends COVID-19 convalescent plasma in the context of a clinical trial. (Knowledge gap)...
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Virus World
Virus World provides a daily blog of the latest news in the Virology field and the COVID-19 pandemic. News on new antiviral drugs, vaccines, diagnostic tests, viral outbreaks, novel viruses and milestone discoveries are curated by expert virologists. Highlighted news include trending and most cited scientific articles in these fields with links to the original publications. Stay up-to-date with the most exciting discoveries in the virus world and the last therapies for COVID-19 without spending hours browsing news and scientific publications. Additional comments by experts on the topics are available in Linkedin (https://www.linkedin.com/in/juanlama/detail/recent-activity/)
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Cell-Based Coronavirus Assays for Evaluation of COVID-19 Antibodies, Vaccines, and Antivirals

Cell-Based Coronavirus Assays for Evaluation of COVID-19 Antibodies, Vaccines, and Antivirals | Virus World | Scoop.it

RetroVirox offers a menu of cell-based antiviral services to evaluate experimental therapies and vaccines against coronaviruses, including SARS-CoV-2. The company offers in vitro testing with SARS-CoV-2 pseudovirions and with  live SARS-CoV-2 viruses to evaluate entry inhibitors, neutralizing antibodies, and antivirals against the novel coronavirus causative agent of COVID-19. Multiple viral strains are available for testing, including the South Africa (B.1.351), Brazil (P.1), and the U.K. variant B.1.1.7. Pseudoviruses are coated with the viral spike (S) protein of SARS-CoV-2 to recapitulate the mode of entry of the novel coronavirus. The assay can be used for the following purposes:

 

  • To determine the neutralizing activity of therapeutic antibodies and antisera
  • To test experimental COVID-19 vaccines using antisera from inoculated animals or humans
  • To evaluate small-molecule and other entry inhibitors targeting the S viral protein, the ACE-2 viral receptor, or host proteases and other targets involved in SARS-CoV-2 viral entry

 

Assays with live replicating SARS-CoV-2, and milder forms of seasonal human coronaviruses (hCoV-OC43  and 229E) allow for the evaluation of inhibitors at all stages of the coronavirus life cycle. Additional Information about the coronavirus assays offered at RetroVirox is available here. Request additional information by email at info@retrovirox.com

Andrrey Yatsenko's curator insight, December 26, 2020 1:15 PM
New  immunity  for  people in the  world to COVID -19 is  result of  evolution !!!
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Gene Therapy Restores Immune Function in Children with Rare Immunodeficiency

Gene Therapy Restores Immune Function in Children with Rare Immunodeficiency | Virus World | Scoop.it

Researchers found that 48 of 50 children retained their replenished immune system function two to three years later and did not require additional treatments for ADA-SCID.  An investigational gene therapy can safely restore the immune systems of infants and children who have a rare, life-threatening inherited immunodeficiency disorder, according to research supported in part by the National Institutes of Health. The researchers found that 48 of 50 children who received the gene therapy retained their replenished immune system function two to three years later and did not require additional treatments for their condition, known as severe combined immunodeficiency due to adenosine deaminase deficiency, or ADA-SCID. The findings were published today in the New England Journal of Medicine. ADA-SCID, which is estimated to occur in approximately 1 in 200,000 to 1,000,000 newborns worldwide, is caused by mutations in the ADA gene that impair the activity of the adenosine deaminase enzyme needed for healthy immune system function. This impairment leaves children with the condition highly susceptible to severe infections. If untreated, the disease is fatal, usually within the first two years of life.  “These findings suggest that this experimental gene therapy could serve as a potential treatment option for infants and older children with ADA-SCID,” said Anthony S. Fauci, M.D., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

 

“Importantly, gene therapy is a one-time procedure that offers patients the hope of developing a completely functional immune system and the chance to live a full, healthy life.” People with ADA-SCID can be treated with enzyme replacement therapy, but this treatment does not fully reconstitute immune function and must be taken for life, usually once or twice weekly. Transplants of blood-forming stem cells, ideally from a genetically matched sibling donor, can provide a more lasting solution. However, most people lack such a donor. Additionally, stem cell transplants carry risks such as graft-versus-host disease and side effects from chemotherapy medications given to help the donor stem cells establish themselves in the patient’s bone marrow.   The new research evaluated an experimental lentiviral gene therapy designed to be safer and more effective than previously tested gene-therapy strategies for ADA-SCID. This gene therapy involves inserting a normal copy of the ADA gene into the patient’s own blood-forming stem cells. First, stem cells are collected from the patient’s bone marrow or peripheral blood. Next, a harmless virus is used as a “vector,” or carrier, to deliver the normal ADA gene to these cells in the laboratory. The genetically corrected stem cells then are infused back into the patient, who has received a low dose of the chemotherapy medication busulfan to help the cells establish themselves in the bone marrow and begin producing new immune cells. 

 

The experimental gene therapy, developed by researchers from the University of California, Los Angeles (UCLA) and Great Ormond Street Hospital (GOSH) in London, uses a modified lentivirus to deliver the ADA gene to cells. Previous gene-therapy approaches for ADA-SCID have relied on a different type of virus called a gamma retrovirus. Some people who have received gamma retroviral gene therapies have later developed leukemia, which scientists suspect is due to the vector causing activation of genes that control cell growth. The lentiviral vector is designed to avoid this outcome and to enhance the effectiveness of gene delivery into cells. The results come from three separate Phase 1/2 clinical trials, two conducted in the United States and one in the United Kingdom. The U.S. trials, led by principal investigator Donald Kohn, M.D., of UCLA, enrolled 30 participants with ADA-SCID ranging in age from 4 months to 4 years at UCLA Mattel Children’s Hospital and the NIH Clinical Center in Bethesda, Maryland. The U.K. study, conducted at GOSH and led by principal investigator Claire Booth, M.B.B.S., Ph.D., enrolled 20 participants ranging in age from 4 months to 16 years. Most participants acquired and retained robust immune function following gene therapy — 96.7% after two years in the U.S. studies and 95% after three years in the U.K. study — and were able to stop enzyme replacement therapy and other medications. Of the two participants for whom gene therapy did not restore lasting immune function, one restarted enzyme replacement therapy and later received a successful stem cell transplant from a donor, and the other restarted enzyme replacement therapy.  The lentiviral gene therapy appeared safe overall, although all participants experienced some side effects. Most of these were mild or moderate and attributable to the chemotherapy that the participants received. Researchers observed similar outcomes in all three trials, although there were some differences between the studies. Stem cells were collected from bone marrow in the U.S. trials and from peripheral blood in the U.K. trial. In one of the U.S. trials, 10 children were treated with genetically corrected stem cells that had been frozen and later thawed. The two other trials used fresh stem cell preparations. In the future, the freezing procedure — known as cryopreservation — may allow stem cells to be more easily transported and processed at a manufacturing facility far from the patient’s home and shipped back to a local hospital, reducing the need for patients to travel long distances to specialized medical centers to receive gene therapy. A trial of the cryopreserved treatment is now underway at the Zayed Centre for Research into Rare Diseases in Children in London, in partnership with GOSH...

 

Research published in N.E.J.M. (May 11, 2021):

https://doi.org/10.1056/NEJMoa2027675 

 

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Efficacy of NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant | NEJM

Efficacy of NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant | NEJM | Virus World | Scoop.it

BACKGROUND

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1–2 trial involving healthy adults, the NVX-CoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+ T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARS-CoV-2 transmission.

METHODS

In this phase 2a–b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)–negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 1:1 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 μg of recombinant spike protein with 50 μg of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection.

RESULTS

Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, −0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups.

CONCLUSIONS

The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant. 

 

Published in NEJM (May 5, 2021):

https://doi.org/10.1056/NEJMoa2103055 

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COVID-19 Spurring New Cases of Diabetes, Study Shows - Chicago Tribune

COVID-19 Spurring New Cases of Diabetes, Study Shows - Chicago Tribune | Virus World | Scoop.it

COVID-19 isn’t just deadlier for people with diabetes, it’s also triggering the metabolic disease in many who didn’t previously have it, study shows.  When Ziyad Al-Aly’s research team told him how often diabetes appeared to strike COVID-19 survivors, he thought the data must be wrong, so he asked his five colleagues to crunch the numbers again. Weeks later, they returned the same findings after sifting through millions of patient records. By then Al-Aly had also gone digging into the scientific literature and was starting to come to terms with an alarming reality: COVID-19 isn’t just deadlier for people with diabetes, it’s also triggering the metabolic disease in many who didn’t previously have it.  “It took a while to convince me,” said Al-Aly, who directs the clinical epidemiology center at the Veterans Affairs St. Louis Health Care System in Missouri. “It was hard to believe that COVID could be doing this.” Among COVID-19′s many ripple effects, the worsening of the global diabetes burden could carry a heavy public health toll. The underlying mechanisms stoking new-onset diabetes aren’t clear, though some doctors suspect the SARS-CoV-2 virus may damage the pancreas, the gland that makes insulin that is needed to convert blood-sugar into energy. Sedentary lifestyles brought on by lockdowns could also be playing a role, as might late diagnoses after people avoided doctors’ offices. Even some children’s mild coronavirus cases can be followed by the swift onset of diabetes, scientists found.

 

Considered a lung disease in the early days of the pandemic, COVID-19 is increasingly recognized for its ability to ravage multiple organs and bodily systems, causing persistent and sometimes debilitating symptoms in 1 in 10 sufferers months after their apparent recovery. Lingering metabolic complications, sometimes requiring high doses of insulin, suggest a subset of survivors are developing diabetes — swelling the ranks of the more than the 463 million people living with the chronic condition.  The disease, in which the body fails to produce enough or properly use insulin, cost an estimated $760 billion in the year before COVID-19 struck, driven by life-shortening complications spanning stroke and kidney failure to foot ulcers and blindness. Al-Aly and colleagues were the first to measure the effect in the U.S. based on evidence from the national health care databases of the Department of Veterans Affairs. They found that COVID-19 survivors were about 39% more likely to have a new diabetes diagnosis in the six months after infection than non-infected users of the VA health system. The risk works out to about 6.5 additional diabetes cases for every 1,000 COVID-19 patients who don’t end up in the hospital. For those who do, the probability jumps to 37 per 1,000 — and it’s even higher for patients who required intensive care. The numbers should be viewed in the context of COVID-19′s sprawling reach, according to Al-Aly. During the winter peak, more than 130,000 patients were hospitalized with the coronavirus in the U.S. alone. Globally, SARS-CoV-2 is reported to have infected more than 153 million people, including over 20 million in India, the country with the most people living with diabetes after China. Al-Aly’s data was published last month in Nature, three weeks after a study of almost 50,000 hospitalized COVID-19 patients in England found that they were 50% more likely to have diabetes some 20 weeks after discharge than matched controls. “We have a risk of seeing a clash of two pandemics,” said Francesco Rubino, chair of metabolic and bariatric surgery at King’s College London, who set up a global registry of COVID-19-related diabetes cases with Paul Zimmet, a professor of diabetes at Melbourne’s Monash University. Researchers have hypothesized pathways in which COVID-19 might increase the likelihood of a diabetes diagnosis, including the possibility that the pancreas’ insulin-excreting beta cells are destroyed either by the virus or by the body’s response to the infection.

 

Other explanations may include an acute stress response to the infection, the use of steroid treatments that help survival but increase blood-sugar, or just the unmasking of diabetes cases that had previously escaped diagnosis, according to John Nicholls, a clinical professor of pathology at the University of Hong Kong. Almost 500 doctors from around the world have agreed to share data via Rubino’s diabetes registry. They will upload patients’ known risk factors, lab results, clinical features, treatment and disease course — information that will help identify the most prevalent form of the disease, possible causes and likely prognoses. So far, close to 350 cases have been documented through the registry and descriptive anecdotes are flowing in almost every day through emails from concerned patients and parents. “People write to us and say, ‘My son just got diagnosed with diabetes. He’s an 8-year-old. He just got COVID last month or two months ago. Could it be related?’” Rubino said. The question of whether SARS-CoV-2 is capable of inducing diabetes is controversial. Surveillance for diabetes from population-based data may be a clearer way to gauge the pandemic’s impact, said Jonathan Shaw, deputy director of the Baker Heart and Diabetes Institute in Melbourne. In Los Angeles, meantime, doctors report a worrying pattern among children with new cases of Type 2 diabetes — the chronic form linked to obesity and sedentary lifestyles that’s mainly seen in adults. They found that one in five new pediatric Type 2 cases last year required hospitalization for diabetic ketoacidosis, a dangerous buildup of acid in the blood due to inadequate insulin supply. By contrast, only 3% of new patients faced this life-threatening problem in 2019. While none of the children in 2020 had active COVID-19, doctors weren’t systematically testing for a prior SARS-CoV-2 infection. Of those who were tested, a third were positive. “Could that explain some of the increase? We really just don’t know,” said Lily Chao, interim medical diabetes director at Children’s Hospital Los Angeles. “But that is one thing that is going through the back of our heads.” Doctors in Canada suggest a drop in utilization of medical services during the pandemic might have delayed care for children with new-onset Type 1 diabetes — the rarer form caused by an autoimmune reaction that destroys insulin-producing cells in the pancreas. A study from Alberta province found the incidence of severe diabetic ketoacidosis in these patients more than doubled to 27% in 2020. Chao sees other plausible drivers related to COVID-19. The pandemic itself has also resulted in lifestyle changes that may be putting kids at risk of diabetes. “For Los Angeles, schools were shut down for a whole year,” she said. “Many of our children have just been home and frankly not getting the best nutrition and gaining more weight. It’s a complex situation.” Rubino aims to publish initial findings from the diabetes registry data midyear, and offers a word of early caution already: There’s enough evidence of COVID-19′s long-term consequences that it should be avoided at any age. “This is not just a flu that, OK, you’ve got it and you’re done with it,” he said. “You might not be done. It’s a serious thing.”

 

Study cited published in Nature (April 22, 2021):

https://doi.org/10.1038/s41586-021-03553-9 

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Moderna Says its COVID-19 Vaccine is 96% Effective in Teens - CBS News

Moderna Says its COVID-19 Vaccine is 96% Effective in Teens - CBS News | Virus World | Scoop.it

Drugmaker said Phase 2 trial of its coronavirus vaccine showed promising results in teens 12- to 17-years-old.  Moderna's COVID-19 vaccine is 96% effective in teenagers 12- to 17-years-old, the drugmaker said Thursday. The company announced results of the Phase 2 trial in reporting first-quarter earnings. Its  vaccine generated $1.7 billion in revenue in its fiscal first quarter.

Evidence that Moderna's vaccine is effective in teens comes as rival Pfizer is expected to receive federal authorization by early next week to use its COVID-19 vaccine in adolescents. Federal approval of one or more vaccines against the disease could enable many American middle and high school students to be vaccinated before the start of the 2021-22 school year. Currently, COVID-19 vaccines are only approved for use in people 16 and older. 

Moderna said that its vaccine trial for younger people, which had more than 3,200 participants, included 12 cases that started 14 days after the first dose. The company said no serious side effects were found, although common side effects included pain at the injection site and, after the second dose of vaccine, headache, fatigue, myalgia and chills. The pharmaceutical firm said it's continuing to collect data in the teen trial and "is in discussions with regulators about a potential amendment to its regulatory filings."

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Prior SARS-CoV-2 Infection Rescues B and T Cell Responses to Variants After First Vaccine Dose | Science

Prior SARS-CoV-2 Infection Rescues B and T Cell Responses to Variants After First Vaccine Dose | Science | Virus World | Scoop.it

SARS-CoV-2 vaccine rollout has coincided with the spread of variants of concern. We investigated if single dose vaccination, with or without prior infection, confers cross protective immunity to variants. We analyzed T and B cell responses after first dose vaccination with the Pfizer/BioNTech mRNA vaccine BNT162b2 in healthcare workers (HCW) followed longitudinally, with or without prior Wuhan-Hu-1 SARS-CoV-2 infection. After one dose, individuals with prior infection showed enhanced T cell immunity, antibody secreting memory B cell response to spike and neutralizing antibodies effective against B.1.1.7 and B.1.351. By comparison, HCW receiving one vaccine dose without prior infection showed reduced immunity against variants. B.1.1.7 and B.1.351 spike mutations resulted in increased, abrogated or unchanged T cell responses depending on human leukocyte antigen (HLA) polymorphisms. Single dose vaccination with BNT162b2 in the context of prior infection with a heterologous variant substantially enhances neutralizing antibody responses against variants.

 

Published in Science (April 30, 2021):

https://doi.org/10.1126/science.abh1282 

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