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Trial Testing Rare Disease Drug for Covid-19 Pneumonia

Human lungs illustration

(NIH.gov)

11 Aug. 2020. A clinical trial is underway assessing a drug approved for a rare inherited disease as a treatment for people hospitalized with pneumonia from Covid-19 infections. The study is testing the drug Ruconest, made by Pharming Group N.V. in Leiden, the Netherlands, enrolling the first Covid-19 patient at University Hospital Basel in Switzerland.

Pharming Group is a biotechnology company designing biologic drugs produced in genetically-engineered animals from proteins expressed only in the milk of the animals. The company’s lead product is Ruconest, approved in Europe, the U.S., Israel, and South Korea to treat hereditary angioedema, a rare but life-threatening inherited condition. Hereditary angioedema occurs in about 1 in 30,000 individuals and causes swelling of hands, feet, face, and airways, as well as severe pain and vomiting.

Ruconest is an engineered C1 esterase inhibitor protein that in most people regulates several inflammatory pathways, but when mutated can trigger excessive swelling characteristic of hereditary angioedema. C1 esterase inhibitor is also part of the complement system, a series of proteins in blood plasma that help the immune system fight infections.

In April, doctors at University Hospital Basel gave Ruconest to five patients with severe pneumonia complications from Covid-19 infections, who did not respond to other treatments including hydroxychloroquine and the AIDS drugs lopinavir/ritonavir. Pharming Group says within 48 hours, fever and inflammation biomarkers in four of the five patients decreased, who were discharged from the hospital soon thereafter. The fifth patient required supplemental oxygen and intensive care, but has since been released. All five patients are now fully recovered.

The clinical trial plans to enroll up to 150 patients in a randomized, controlled study testing Ruconest as a treatment for patients with pneumonia resulting from Covid-19 infections. Other sites are expected to join University Hospital Basel. The study is not yet listed at U.S. or European clinical trial registries.

Michael Osthoff, the study team leader at University Hospital Basel, says in a Pharming Group statement, “After the encouraging results observed in five patients treated with Ruconest in our clinic, it is justified to investigate this drug and its unique mode of action of targeting several inflammatory cascades in a clinical trial with a large number of patients. We will gather precious information about efficacy, safety and appropriate dosing of the drug in the treatment and prevention of the severe complications of Covid-19.”

Pharming Group says if the trial is successful, the company plans to test Ruconest as a treatment for other hyper-inflammatory outcomes of Covid-19 infections in some patients, including blood clots throughout the body and cytokine storms that lead to organ failure and death.

“We have learned that cytokine storms caused by complement system activation cannot be controlled by targeted anti-inflammatory therapies,” notes Bruno Giannetti, Pharming Group’s chief medical officer. “Instead, broad anti-inflammatory agents are required to stop the activation of multiple inflammation pathways. Ruconest’s multiple interactions with key inflammation pathways therefore make it a promising candidate to prevent the severe complications observed in Covid-19 patients.”

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Breath Analysis Sensor Licensed to Detect Covid-19

Birthday candles

(profivideos, Pixabay)

10 Aug. 2020. Discoveries in a university lab that enable detection of Covid-19 infections from a person’s breath are being licensed for development by a biotechnology company. Hoth Therapeutics Inc. in New York is acquiring development rights to a sensor analyzing breath gases, first researched in engineering labs at George Washington University in Washington, D.C.

The technology is a product of GWU’s Institute for MEMS and VLSI. MEMS stands for micro-electronic mechanical systems, the intersection of mechanical functions with integrated circuits and VLSI is very large scale integration, combining thousands of integrated circuits on a single chip. The institute, led by engineering professor Mona Zaghloul, studies design of chips that adapt chemical and biological sensing to MEMS and VLSI circuits.

Yangyang Zhao, a recent GWU engineering doctorate, working under Zaghloul and with National Institute of Standards and Technology, designed and fabricated nanoscale gas sensors with plasmonic properties, where light waves excite electrons in characteristic patterns, as when detecting the presence of certain biological molecules. The sensor surface is lined with a thin gold film that binds with gas molecules in a person’s breath. When light passes over the sensor, the light reflects in various wavelengths, with SARS-CoV-2 virus or other target molecules bound to the sensor reflected in signature colors.

Jeanne Jordan, professor of epidemiology at GWU’s school of public health recognized the potential for the technology, and worked with the engineers to refine the sensors for quick detection of Covid-19 infections. Those refinements led to a thin sensor coated with a solution that reacts to SARS-CoV-2 viruses in exhaled breath and immediately changes color. The color change can then be captured on a smartphone’s camera and uploaded for analysis in the cloud. No nasal swabs or saliva are needed.

“These are devices,” says Jordan in a Hoth Therapeutics statement, “that a public health professional could go out with into the field to administer point-of-care testing, either at a walk-up center or directly in the community.” Jordan adds, “They’re extremely rapid; the turnaround time to having test results is within minutes, and you do the testing right there instead of having to send your sample to a large commercial laboratory with a massive backlog. That would allow these professionals to say immediately if someone needs to be quarantined, and to get the names of their contacts so they can start contact tracing.”

Hoth Therapeutics develops biological drugs for skin conditions and antibiotics, particularly for stubborn bacterial biofilms that can aggravate skin infections. In March, Hoth formed HaloVax LLC in a joint venture with Voltron Therapeutics to develop a vaccine to protect against Covid-19 infections, based on a technology licensed from Massachusetts General Hospital in Boston.

“The immediate diagnosis and ongoing tracking of Covid-19,” notes Hoth CEO Robb Knie, “is a critical initiative towards mitigating the ongoing spread of Covid-19.  This device, which is under development, would allow users to conduct widespread testing and provide instantaneous results through the administration of a breath sample and tracking through a mobile device.”

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Covid-19 Vaccines, Therapies – 10 August 2020

Covid-19 vaccine and therapy tracker

BioRender Covid-19 vaccine and therapy tracker. (BioRender.com)

10 Aug. 2020.  A regular Monday feature on Science & Enterprise is an update on Covid-19 therapies and vaccines in development. The report is provided by BioRender, in Toronto, Ontario, a company offering illustration and graphics tools for life sciences, biotechnology, and other disciplines.

This week’s chart shows a burst of activity for both Covid-19 vaccines and therapies since last Monday. Seven new vaccine projects got underway last week, raising the total to 164, with six more vaccines reaching clinical trials now totaling 41. And 19 more therapies are in development, bringing that total to 356, while 11 more therapies entered clinical trials, raising that total to 270.

In addition to the summary dashboard shown above, the BioRender Covid-19 vaccine and therapy page provides details of the vaccines and therapies, as well as an activity feed showing news updates on these drugs.

The race to develop both vaccines and therapies for Covid-19 has put a spotlight on adaptive clinical trials, a new type of study that produces quality data like gold-standard randomized clinical trials, but allows for more complex conditions, altering course in the middle of the trial, and testing multiple drugs or medical devices at one time. Last week, as reported by Science & Enterprise, National Institutes of Health launched its Activ-2 and Activ-3 clinical trials, mid- and late-stage studies of Covid-19 therapies using an adaptive design.

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Infographic – Mental Health Effects of Pandemic

Covid-19 and mental health chart

Click on image for full-size view (Statista)

8 Aug. 2020. The physical symptoms experienced by people with Covid-19 infections are well documented over the past few months, but the psychological toll is also beginning to get attention. The business research company Statista published a chart yesterday with data from a report by the Commonwealth Fund showing one measure of those effects, displayed in this weekend’s infographic.

The Commonwealth Fund, a 102 year-old foundation in New York focusing on public health, conducted surveys in the U.S. and eight Western countries, from February to June, with questions on mental health experiences. The findings, released this week, show about one in three Americans (32%) say they experience stress, anxiety, or great sadness they find difficult to cope with alone since the start of the pandemic.

While the U.S. has the highest percentage with these experiences, it is hardly alone. About a quarter, 23 to 26 percent, of respondents in five countries — Canada, U.K., France, Australia, and New Zealand — also admit to these pressures. From one to two in 10 of respondents in Sweden (18%), Netherlands (14%), and Norway (10%) likewise have these difficulties.

Another question on the survey points to a likely cause of these pressures. Some three in 10 Americans (31%) and a quarter of Canadians (24%) say they suffered economic consequences during the pandemic. The question asked specifically if respondents if they were unable to pay for basic necessities like food and rent, used up most of their savings, or took out a loan because of the pandemic. About two in 10 respondents in Australia (21%), Sweden (19%), U.K. (18%), and New Zealand (18%) also admitted to personal economic effects from the pandemic.

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Giant Hornet Genome Sequenced

Asian giant hornet

Asian giant hornet (Matthew Buffington, ARS)

7 Aug. 2020. The genome of the Asian giant hornet, a species threatening bees and humans, was analyzed, with the data released by the Agricultural Research Service. The biotechnology company Pacific Biosciences in Menlo Park, California performed much of the genomic sequencing of the invasive insect, which first appeared last year in Washington State and British Columbia.

The Asian giant hornet — Vespa mandarinia, nicknamed the murder hornet — is native to India and East Asia, and one of the largest wasps, ranging from 1.5 to 2 inches long. The insects are known to attack honey bee colonies with their strong jaws and venom, and thus are considered a threat to bee keepers. Just 10 hornets can reportedly destroy an entire hive of European honey bees, the main species found in North America. Honey bees play a vital role in agriculture, pollinating crops that make up about one-third of the fruits and vegetables consumed in the U.S.

Pacific Biosciences conducted the sequencing for ARS. The company performs genomic analyses for biomedical and agricultural research, using what the company calls its high-fidelity sequencing that reads longer strands of DNA with less source material. Reading these longer strands makes it easier to re-assemble the analyzed genome, using in this case the company’s higher-speed assembly process. Using parts of a frozen Asian giant hornet found on Vancouver Island, British Columbia in September 2019, the company was able to complete its analysis in about two months.

ARS, part of the U.S. Department of Agriculture, published the Asian giant hornet sequencing data yesterday on the department’s Ag Data Commons web site, as well as at National Center for Biotechnology Information, part of the National Library of Medicine in NIH. The sequencing data are expected to provide a reference for other labs to develop controls and countermeasures against the hornet.

“Having this reference genome,” says computational biologist and project leader Anna Childers at ARS’s Bee Research Laboratory in Beltsville, Maryland in an agency statement, “will help provide a broader biological picture of the Asian giant hornet. It also will help build an understanding of the dynamics of any Asian giant hornet populations in this country and how they may adapt as well as possibly provide information to sharpen the development of controls to prevent them from becoming established.”

ARS says the two-month turnaround of the analysis indicates agricultural and health authorities can respond to invasive species like the hornet before large-scale damage can occur. The Bee Research Lab plans to gather genomic data of Asian giant hornets still in their native regions, to determine if new sub-species are emerging, as well as determine the source of the North American variety.

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Grant Funds Placenta Stem Cell Trial Sites for Covid-19

Pregnant woman

(Freestocks.org, Unsplash)

6 Aug. 2020. A clinical trial testing stem cells from human placentas as a treatment for Covid-19 infections is expanding to three more sites in California. The new sites for the trial conducted by Celularity Inc., a company based in Florham Park, New Jersey, are funded by a $750,000 grant from the California Institute for Regenerative Medicine, or CIRM.

Celularity develops treatments for cancer, infectious diseases, and other disorders with blood-forming stem cells derived from donated human placenta tissue. The company’s technology extracts natural killer cells, white blood cells in the immune system with target cell-killing capabilities, then frozen and preserved. Celularity says a single placenta can generate thousands of doses, with its placenta cell products produced quickly and used off-the-shelf with no adverse immune effects, rather than cells cultured from individual patients.

The biotechnology company’s lead product, code-named CYNK-001, is already in early- and mid-stage clinical trials for blood-related cancers, multiple myeloma and acute myeloid leukemia. In January, Science & Enterprise reported on FDA authorization for an additional early-stage trial testing CYNK-001 as a treatment for glioblastoma multiforme, an aggressive brain cancer.

In April, Celularity received clearance from FDA for a clinical trial to test CYNK-001 as a treatment for Covid-19 infections. The company says its preclinical tests show natural killer cells generated from CYNK-001 activate cell-killing receptor proteins that bind to viral antigens on infected cells. Its findings also show the natural killer cells express cell-killing molecules perforin and granzymes that can stop replication of SARS-Cov-2 viruses in human cells. Celularity says these CYNK-001 properties can help infected patients block further progression of the disease and allow the body’s adaptive immune system to clear the virus.

“CYNK-001,” says Celularity chief scientist Xiaokui Zhang in a company statement, “has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection.” The company says CYNK-001 has already been used under compassionate use authorization to treat people with severe Covid-19 infections, including patients requiring ventilators, with the treatments well tolerated and associated with clinical benefits in some cases.

The company’s clinical trial is an early- and mid-stage study enrolling 86 patients hospitalized at four locations for Covid-19 infections, but showing no more than moderate symptoms. The first 14 patients receive three infusions of CYNK-001 on days 1, 4, and 7, looking mainly for adverse events, but also clearance of SARS-Cov-2 viruses and changes in lower respiratory tract symptoms.

The next 72 individuals are randomly assigned to receive three CYNK-001 infusions, three days apart, compared to patients receiving the best standard care. Participants are followed for the next 28 days looking for the time needed to clear SARS-CoV-2 viruses from the body, as well as improvement in symptoms related to lower respiratory tract infections. In the second stage, the study team is also watching for signs of adverse effects.

The $750,000 CIRM grant funds an extension of Celularity’s clinical trial to three more sites in California. The first of those locations is University of California in Irvine.

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Start-Up to Engineer T-Cells for Autoimmune Diseases

Human T-cell

Scanning electron micrograph of a healthy human T-cell (NIH.gov)

6 Aug. 2020. GentiBio Inc., a new enterprise in Boston, is starting work on creating engineered T-cells from the immune system to treat autoimmune diseases. The company is licensing research from labs at Seattle Children’s Research Institute, Benaroya Research Institute also in Seattle, and MIGAL Galilee Research Institute in Kiryat Shmona, Israel, and raising $20 million in seed funds.

GentiBio plans to develop and produce engineered regulatory T-cells as therapies for autoimmune disorders. T-cells are white blood cells in the immune system stimulated by antigens to fight invading pathogens, with regulatory T-cells acting as controllers of immune reactions. In autoimmune disorders, regulatory T-cells fail to control effector T-cells that attack healthy cells and tissues in the body, instead of invading pathogens from outside. Examples of autoimmune disorders are type 1 diabetes, rheumatoid arthritis, lupus, psoriasis, Crohn’s disease, and multiple sclerosis.

In June, researchers led by immunologist David Rawlings at Seattle Children’s and a scientific co-founder of GentiBio, published a paper in the journal Science Translational Medicine describing the company’s technology. Rawlings and colleagues use gene editing techniques to alter a type of regulatory T-cells to express the protein FOXP3 that suppresses autoimmune activity. Using regulatory T-cells, or Tregs, from human blood, Rawlings and colleagues demonstrate the engineered T-cells enable the suppression of inflammatory conditions graft-versus-host disease and autoimmune encephalitis in lab cultures and animals.

Rawlings notes in a company statement released through Cision, “Tregs are rare cells within the immune system and current therapies that source Tregs cells from the blood stream can be costly and cumbersome.” He adds that his lab devised techniques to create engineered Tregs, or EngTregs, from more abundant CD4+ T-cells in the adaptive immune system, “addressing a critical manufacturing shortcoming for this novel treatment.”

The company is receiving an exclusive license to EngTreg technologies developed at Seattle Children’s, Benaroya Research Institute, and MIGAL. The company plans to design EngTregs to address specific antigens, proteins that invoke an immune response, as well as produce therapies for autoimmune disorders that restore immune tolerance and repair damaged tissues.

Jane Buckner — rheumatologist, president of Benaroya Research Institute, and co-author of the Science Translational Medicine paper — is also a scientific co-founder of GentiBio. Benaroya Research Institute, part of Virginia Mason Medical Center in Seattle, studies autoimmune diseases.

“Currently,” notes Buckner, “the majority of available treatments indiscriminately suppress the immune system, leaving the body vulnerable to infections. EngTregs endowed with antigen specific moieties can selectively restrict inflammation temporally and spatially in specific tissues where it’s beneficial.”

Adel Nada, a physician and co-founder of GentiBio, is the company’s CEO. “GentiBio is focused on addressing  the technical bottlenecks that have throttled Treg therapeutics,” says Nada. He adds, “The technologies licensed from these premier research institutions are mature and well-differentiated, and will be further optimized in sponsored research collaborations with the scientific teams that discovered them to advance novel and potent therapeutics with the potential to treat and cure serious autoimmune and inflammatory diseases.”

GentiBio is raising $20 million in its seed funding round. Venture investors OrbiMed, Novartis Venture Fund, and RA Capital Management L.P led the financing.

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Venture Fund Plans $350M for Biotech Start-Ups

Investment graphic

(Gerd Altmann, Pixabay)

5 Aug. 2020. A new venture fund plans investments in early-stage life science companies addressing critical needs in therapeutics, but also agriculture and industrial biotechnology. Data Collective DCVC in San Francisco and Palo Alto, California says it raised $350 million for its DCVC Bio II fund for start-up companies creating what it calls deep tech solutions for challenges presented by climate change and the global food supply, as well as health care.

DCVC Bio II follows its DCVC Bio I fund that began in 2018. Among the investments from the earlier fund reported on most recently by Science & Enterprise are AbCellera Biologics in Vancouver, British Columbia, developing engineered antibodies to treat Covid-19 infections with drug maker Eli Lilly and Co. In May, AbCellera raised $105 million in its second venture round, with DCVC taking part, as well as in AbCellera’s earlier venture round.

In June 2019, DCVC took part in the first venture round for Frontier Medicines Corp. in South San Francisco, a spin-off enterprise from labs at University of California in Berkeley, creating treatments that target cancer-causing proteins considered unreachable with current therapies. In addition, DCVC led the December 2018 seed round for GenEdit Inc. in Berkeley, California, also a UC – Berkeley spin-off business, developing nanoscale particles to deliver gene-editing enzymes, including those for Crispr.

DCVC says it raised the $350 million in its second fund completely during the pandemic, citing the increased public attention to biotechnology from the critical need for vaccines and treatments. The company says it’s looking for start-up biotech companies with solutions that can make a difference dealing with today’s pressing health problems, but also targeting the next pandemic or big climate emergency, easing disruptions in global food supply chains, or creating high-performance yet sustainable industrial materials.

DCVC cites AbCellera as an example of that kind of business, first developing a technology platform to address the overall global threat of pandemics, which enables its urgent response to today’s needs for therapies and vaccines to combat Covid-19. The company says its DCVC Bio II limited partners — part-owners providing investment capital, but not managing the fund — share the managers’ objectives and outlook.

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Why You Should Go Back To College for Science

– Contributed content –

Scientist in lab

(Defense.gov)

5 Aug. 2020. As a grown adult you may find that you wouldn’t want to go back to college for fear of being ‘too old’. Many people adopt this mentality and refuse to reassess their career and pursue their dreams, simply because they fear standing out against a crowd of young people. Despite this negative stereotype of being ‘past it’, there are actually huge benefits of returning to college to study as an older student. If you have always had a passion for or interest in science but took a different path earlier in life, you might find happiness by going back to school and studying science!

Why study science?

It would be far shorter to list reasons why you should not study science! Look around, and you’ll realize that now more than ever is the time to become a scientist. Whether your interest lies in climate change; medical sciences; space travel and astrophysics; marine biology or something totally different, every single area of the sciences is under immense pressure right now.

So why not study science and be at the forefront of helping our world which is increasingly fragile? You could help protect endangered species! You could help the world understand space travel better! You could help keep the Earth cool and reduce global warming’s devastating effects! The possibilities are endless.

Why study as a mature student?

If you never went to college, or you attended college to study something else, you may wonder why it would be worth returning to study something new as an older person. So much of the college experience is wrapped up in being young; the parties, the relaxed lifestyle and the experimentation of your early twenties. However, college nowadays is so much more than this. As an older student you would be bringing life experience, knowledge and maturity to the table. You could make friends of all ages and collaborate with them. College isn’t all about being young, and it’s never too late to learn something new.

But what about the money?

That’s right – one of the main reasons people don’t go back to college is the debt incurred by doing so. It’s scary. Depending on your school of choice and state of residence, you could incur hundreds of thousands of dollars of debt by returning to college at a later age. If you have a family and/or are a homeowner, this could put pressure on your finances.

If you are concerned about debt, speak to a financial advisor about your options. It is always possible to achieve your dreams, and a financial advisor may be able to guide you through a different way of looking at your future financial situation. For example, studying an impressive scientific subject at college is likely to land you a higher-paying job which can help you and your family in the long run!

If you are concerned about pre-existing debt affecting your chances, see www.dtss.us/debt-discharge.html for more.

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NIH Begins Covid-19 Antibody Trials

Global Covid-19

(Gerd Altmann, Pixabay)

5 Aug 2020. National Institutes of Health is beginning clinical trials of experimental antibody therapies to treat Covid-19 infections in people with symptoms ranging from mild to severe. The first treatment tested in the mid- and late-stage studies is an engineered antibody developed by drug maker Eli Lilly and Co., biotechnology company AbCellera Biologics, and the Vaccine Research Center at National Institute of Allergy and Infectious Diseases, part of NIH.

The trials are part of NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines, or Activ, program to streamline and coordinate actions to combat the Covid-19 pandemic among agencies in the U.S. government, private pharmaceutical and biotech companies, international agencies, and not-for-profit groups. Among Activ’s goals is to accelerate evaluation of vaccine and therapy candidates to speed regulatory approval, including clinical trials of experimental drugs.

Both the Activ-2 and Activ-3 clinical trials use an adaptive design that allow for changing the course of the study while underway, without compromising gold-standard quality of the efficacy or safety data. Adaptive trials are usually governed by a single governing board and master protocol spelling out ground rules for the study, including standards and processes for assessing results, adding or closing sample groups, and adding new drugs or devices for testing. With these common rules, standards, and practices in place, adaptive trials make it possible to evaluate drugs and devices quicker, add new population groups to a study, or close treatment interventions if needed, even as data are being collected.

First treatment assessed: LY-CoV555

LY-CoV555 is a product of Eli Lilly and Co. in Indianapolis and AbCellera Biologics in Vancouver, British Columbia, Canada. AbCellera uses what it calls deep mining of B-cells from the immune system to discover antibodies for preventing and treating diseases caused by a range of viruses and bacteria. B-cells are white blood cells in the immune system that produce antibodies, proteins that directly attack invading pathogens, such as bacteria and viruses.

As reported by Science & Enterprise in March, AbCellera says it screened more than five million immune-system cells against a blood sample from one of the first people in the U.S. infected with novel coronavirus. From this screening, AbCellera says it identified some 500 unique human antibody sequences that respond to the SARS-CoV-2 virus responsible for Covid-19 infections. From this screening and help from Vaccine Research Center at NIAID, the companies developed LY-CoV555, an engineered immunoglobulin G antibody designed to block the SARS-CoV-2 spike protein that penetrates and infects cells.

Eli Lilly and AbCellera share LY-CoV555’s development work, while Lilly is responsible for further development, regulatory approvals, manufacturing, and distribution. Earlier this week, the companies said they’re testing LY-CoV555 among residents and staff in long-term care facilities in the U.S.

Activ-2 and -3 clinical trials

The Activ-2 trial is testing treatments for people infected with SAR-CoV-2 viruses responsible for Covid-19, but not requiring hospitalization. The study is initially enrolling 220 participants, randomly assigned to receive an LY-CoV555 infusion or a placebo. Participants will then be tracked for the next four weeks, checking for adverse reactions to the treatment, and tested for SAR-CoV-2 in nasal and saliva samples, blood oxygen levels using a pulse oximeter, and antibody concentrations in blood samples. The main efficacy measures are prevention of hospitalization and survival time of participants.

If results from the first 220 participants look promising, the Activ-2 trial will add a larger-scale sample of 1,780 participants, also individuals with Covid-19 infections, but not needing hospitalization. These participants will also be randomly assigned to receive LY-CoV555 or a placebo, and be assessed for 28 days with similar samples and measures as the smaller group.

The Activ-3 trial is testing LY-CoV555 among patients hospitalized with Covid-19 infections. Like the Activ-2 trial, Activ-3 is first recruiting a sample of 300 participants with Covid-19 and displaying no more than moderate symptoms, randomly assigned to receive LY-CoV555 infusions or a placebo. All patients in the trial are also receiving the antiviral drug remdesivir, approved by FDA as a treatment for advanced Covid-19 infections. After five days, patients are assessed for adverse reactions to the treatment and severity of their symptoms, including the need for supplemental oxygen, use of a ventilator, or other supportive care.

If results from this first group show LY-CoV555 is safe and effective, Activ-3 will add 700 more participants to the sample, although the new patients will include more severe cases, including those needing mechanical ventilation and with organ failure other than the lungs. The main efficacy measure is sustained recovery of patients for 14 days following release from the hospital.

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