Daily Archives: April 25, 2021

SOURCES:

UpToDate: Coronavirus disease 2019 (COVID-19): Epidemiology, virology, clinical features, diagnosis and prevention.

Medscape: Kidney Complications in COVID-19 Send Hospitals Scrambling.

Global Radiology CME: COVID-19 Presenting with Syncope.

Iranian Red Crescent Medical Journal: Frequent Convulsive Seizures in an Adult Patient With COVID-19: A Case Report.

Consul General of the Official Colleges of Podiatrists, Spain: COVID-19 Compatible Case Register.

World Health Organization: Q&A on coronaviruses (COVID-19), Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19).

CDC: Coronavirus disease 2019 (COVID-19) and you, Symptoms of coronavirus disease 2019, Symptoms,Coronavirus Disease 2019 (COVID-19).

University of Alabama at Birmingham: Sorting out symptoms of COVID-19, influenza, colds and allergies.

UpToDate: Coronavirus disease 2019 (COVID-19).

Merck Manual Consumer Version: Fever in Adults, Shortness of Breath.

Loma Linda University Health: Coronavirus 2019 (COVID-19).

American Society of Clinical Oncology: Shortness of Breath or Dyspnea.

American Academy of Family Physicians: Shortness of Breath.

American Academy of Ophthalmology: Coronavirus Eye Safety.

The Lancet Gastroenterology and Hepatology: Liver injury in COVID-19: management and challenges.

National Institute of Allergy and Infectious Diseases Cold, Flu, or Allergy?

The New England Journal of Medicine: Large-Vessel Stroke as Presenting Feature of Covid-19 in the Young.

American Stroke Association: Stroke Symptoms."

Boston Childrens Hospital: COVID-19 and a serious inflammatory syndrome in children: Unpacking recent warnings.

Nemours/KidsHealth: Kawasaki Disease, Fevers.

Morbidity and Mortality Weekly Report: Coronavirus Disease 2019 in Children United States, February 12-April 2, 2020.

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Signs of Coronavirus (COVID-19) - WebMD

The West Virginia Department of Health and Human Resources (DHHR) reports as of April 25, 2021, there have been 2,673,838 total confirmatory laboratory results received for COVID-19, with 151,382 total cases and 2,821 total deaths.DHHR has confirmed the deaths of a 63-year old male from Raleigh County, a 43-year old male from Raleigh County, a 73-year old female from Raleigh County and a 78-year old female from Kanawha County.We remember today the unique burden the pandemic has placed upon children who have suffered loss of a family member, said Bill J. Crouch, DHHR Cabinet Secretary. We must do all we can to support them and keep them safe.CASES PER COUNTY: Barbour (1,368), Berkeley (11,877), Boone (1,928), Braxton (885), Brooke (2,138), Cabell (8,677), Calhoun (276), Clay (467), Doddridge (560), Fayette (3,328), Gilmer (745), Grant (1,248), Greenbrier (2,691), Hampshire (1,742), Hancock (2,732), Hardy (1,461), Harrison (5,506), Jackson (1,951), Jefferson (4,445), Kanawha (14,390), Lewis (1,146), Lincoln (1,421), Logan (2,994), Marion (4,244), Marshall (3,322), Mason (1,946), McDowell (1,525), Mercer (4,625), Mineral (2,797), Mingo (2,457), Monongalia (9,027), Monroe (1,094), Morgan (1,105), Nicholas (1,547), Ohio (4,097), Pendleton (695), Pleasants (848), Pocahontas (657), Preston (2,832), Putnam (4,896), Raleigh (6,390), Randolph (2,508), Ritchie (673), Roane (591), Summers (774), Taylor (1,206), Tucker (524), Tyler (677), Upshur (1,833), Wayne (2,851), Webster (459), Wetzel (1,247), Wirt (384), Wood (7,626), Wyoming (1,949).

Delays may be experienced with the reporting of information from the local health department to DHHR. As case surveillance continues at the local health department level, it may reveal that those tested in a certain county may not be a resident of that county, or even the state as an individual in question may have crossed the state border to be tested.

West Virginians may pre-register for their COVID-19 vaccination at vaccinate.wv.gov. The COVID-19 dashboard located at http://www.coronavirus.wv.gov shows the total number of vaccines administered. Please see the vaccine summary tab for more detailed information.

Free pop-up COVID-19 testing is available today in Greenbrier County and on Monday, April 26 in Barbour, Berkeley, Jefferson, Lincoln, Logan, Marshall, Mineral, Monongalia, Morgan, Pendleton, Preston and Wayne counties:

Greenbrier County

10:00 AM 5:00 PM, Dorie Miller Park, 396 Feamster Road, Lewisburg, WV

April 26

Barbour County

9:00 AM 11:00 AM, Barbour County Health Department, 109 Wabash Avenue, Philippi, WV

1:00 PM 5:00 PM, Junior Volunteer Fire Department, 331 Row Avenue, Junior, WV

Berkeley County

10:00 AM 5:00 PM, 891 Auto Parts Place, Martinsburg, WV

10:00 AM 5:00 PM, Ambrose Park, 25404 Mall Drive, Martinsburg, WV

Jefferson County

10:00 AM 6:00 PM, Hollywood Casino, 750 Hollywood Drive, Charles Town, WV

12:00 PM 5:00 PM, Shepherd University Wellness Center Parking Lot, 164 University Drive, Shepherdstown, WV

Lincoln County

9:00 AM 3:00 PM, Lincoln County Health Department, 8008 Court Avenue, Hamlin, WV (pre-registration: https://wv.getmycovidresult.com/)

Logan County

9:00 AM 9:45 AM, Man City Hall, 105 Market Street, Man, WV (pre-registration: https://wv.getmycovidresult.com/)

10:00 AM 10:45 AM, Kistler Grocery, 601 Buffalo Creek Road, Kistler, WV (pre-registration: https://wv.getmycovidresult.com/)

11:00 AM 11:45 AM, Ellis Supply, 234 Spirit Lane, Accoville, WV (pre-registration: https://wv.getmycovidresult.com/)

12:00 PM 12:45 PM, Buffalo Creek Fire Department, 70 Garrison Drive, Amherstdale, WV (pre-registration: https://wv.getmycovidresult.com/)

1:00 PM 1:45 PM, Buffalo Creek Apartments at Robinette, 40 Johnson Heights Drive, Robinette, WV (pre-registration: https://wv.getmycovidresult.com/)

2:00 PM 2:45 PM, Buffalo Creek Apartments at Crites, 175 Rendezvous Road, Lundale, WV (pre-registration: https://wv.getmycovidresult.com/)

3:00 PM 3:45 PM, Lorado Post Office, 9964 Buffalo Creek Road, Lorado, WV (pre-registration: https://wv.getmycovidresult.com/)

4:00 PM 4:45 PM, Curtis Church, 16541 Buffalo Creek Road, Lorado, WV (pre-registration: https://wv.getmycovidresult.com/)

Marshall County

10:00 AM 2:00 PM, Marshall County Health Department, 513 6th Street, Moundsville, WV (pre-registration: https://wv.getmycovidresult.com/)

Mineral County

10:00 AM 6:00 PM, Mineral County Health Department, 541 Harley O. Staggers Drive, Keyser, WV (pre-registration: https://wv.getmycovidresult.com/)

Monongalia County

9:00 AM 11:00 AM, WVU Recreation Center, lower level, 2001 Rec Center Drive, Morgantown, WV

Morgan County

11:00 AM 4:00 PM, Valley Health War Memorial Hospital, 1 Health Way, Berkeley Springs, WV

Pendleton County

11:00 AM 5:00 PM, Pendleton County Health Department, 273 Mill Road, Franklin, WV (pre-registration: https://wv.getmycovidresult.com/)

Preston County

4:00 PM 5:30 PM, Terra Alta EMS, 1124 East State Avenue, Terra Alta, WV (pre-registration: https://wv.getmycovidresult.com/)

Wayne County

10:00 AM 2:00 PM, Wayne Community Center, 11580 Rt. 152, Wayne, WV

For more free COVID-19 testing opportunities across the state, please visit https://dhhr.wv.gov/COVID-19/pages/testing.aspx.

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COVID-19 Daily Update 4-25-2021 - West Virginia Department of Health and Human Resources

The United States is deeply concerned by a massive surge in coronavirus cases in India and will race additional support to the Indian government and health care workers, a White House spokeswoman said on Saturday.

"We are in active conversations at high levels and plan to quickly deploy additional support to the Government of India and Indian health care workers as they battle this latest severe outbreak. We will have more to share very soon," the spokeswoman told Reuters via email.

Washington is under increasing pressure to do more to help India, the world's largest democracy and a strategic ally in President Joe Biden's efforts to counter China, as it grapples with a record-setting surge in coronavirus infections.

The U.S. Chamber of Commerce on Friday called on the Biden administration to release millions of stored doses of AstraZeneca (AZN.L) vaccine for shipment to India, Brazil and other hard hit countries.

The Indian government has deployed military planes and trains to get urgently needed oxygen to Delhi from other parts of the country and foreign countries, including Singapore.

The number of cases across the country surged by a record daily rise of 349,691 on Sunday, for a total of 16.96 million cases, including 192,311 deaths, the health ministry said.

The country of 1.3 billion people is on the brink of a humanitarian catastrophe, Ashish Jha, dean of the Brown University School of Public Health, warned in an op-ed published Saturday in the Washington Post.

He said some 2,000 people were dying daily, but most experts estimated that the true number was five to 10 times that level.

Officials from both countries are engaged at various levels to ensure a smooth supply of inputs and components from U.S. companies for production of COVID-19 vaccines in India, a spokesman at the Indian Embassy in Washington told Reuters.

He said it was important to work together to identify ways to overcome bottlenecks in medical supply chains and expedite ongoing vaccination efforts.

Jha called on Washington to send India oxygen, excess testing kits and high-quality personal protective equipment, including face masks, and medicines to treat COVID-19 patients, including sedatives and Remdesivir.

Jha also urged the Biden administration to share excess vaccines with India and other countries in crisis, citing some 30 million unused doses of the AstraZeneca vaccine that is in use elsewhere, but has not been authorized by U.S. regulators.

Washington should also lift export controls on raw materials put in place via the Defense Production Act and an associated export embargo in February, Jha wrote.

White House Press Secretary Jen Psaki on Friday said U.S. and Indian officials were working to find ways to help address the crisis, but gave no timetable for the support.

She said the United States has already provided India some $1.4 billion in health assistance, emergency relief supplies, pandemic training for Indian state and local health officials, and ventilators.

Our Standards: The Thomson Reuters Trust Principles.

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U.S. racing to send aid to India as COVID-19 cases soar - Reuters India

Franketa A. Taylor, of Birmingham, was arrested in the U.S. Virgin Islands after authorities say she submitted an altered negative COVID-19 test to the U.S.V.I., online travel portal,according to a Virgin Islands Daily News report Friday.

The report states Taylor is facing charges including: fraudulent claims upon the government, access to a computer for fraudulent purposes, use of false information, and filing or recording forged instruments.

The U.S. Virgin Islands territory currently requires visitors to provide a negative COVID-19 test within five days of arrival, according to cbs42.com.

V.I. Daily News says Taylor is the seventh person thus far to be charged with entering an altered or forged COVID-19 test in the portal, which screens incoming travelers to prevent the spread of the virus.

According to Virgin Island Daily News, Taylor was unable to post her $5,500 bail and was turned over to the V.I. Bureau of Corrections pending an advice-of-rights hearing.

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Alabama woman arrested in Virgin Islands for providing false COVID-19 test - AL.com

Michigan and other states that experienced springtime Covid-19 surges or faced worrisome transmission trends appear to have turned a corner, with drops in new cases in recent days as vaccines reach more people.

After hovering at stubbornly high levels or increasing over the past two months, average daily cases in Massachusetts, Minnesota, New Jersey, Illinois, and other states in the Midwest and Northeast have started to fall, providing a breath of relief that the communities are past their most recent peaks. Crucially, new infections in Michigan which experienced the worst of the spring spikes, with some of its highest Covid-19 levels of the entire pandemic occurring in recent weeks have started declining, with hospitalizations also starting to tick down.

Experts are cautious that the progress has just begun and needs to be sustained if the states want to actually achieve low levels of transmission. But theyre heartened that it appears vaccines are increasingly not just protecting individuals from Covid-19, but are starting to have broader benefits for communities.

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Aprils been a bad month, said Preeti Malani, an infectious disease physician at the University of Michigan. There are hospitals across the state overwhelmed with patients. And because staff are sick, theyve been having trouble with staffing their hospitals. Different parts of the state remain under different levels of pressure, but now, with a big increase in vaccine availability in the past month, Malani said, Im optimistic about the direction were headed.

At the national level, the countrys average daily infection count has also started to come down, from more than 70,000 in the middle of April to closer to 60,000 now. But summarizing the U.S. Covid-19 epidemic from that frame obscures how much variability there is. After experiencing a horrific surge over the winter, California now has one of the lowest rates of infections in the country, while cases in Puerto Rico have increased over the past month.

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We remain in a complicated stage, Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said at a briefing Monday. On the one hand, more people in the United States are being vaccinated every single day at an accelerated pace. On the other hand, cases and hospitalizations are increasing in some areas of the country, and cases among young people who have not yet been vaccinated are also increasing.

The progress in the United States stands in stark contrast to most of the rest of the world, which lacks anything close to the vaccine supply this country has. Persistently high cases in Europe and the Americas and huge spikes in Asia have driven global case counts to among the highest levels of the whole pandemic.

Trends can also be moving in the right direction when, in raw numbers, infections are still high. Cases may be coming down in Michigan, but theyre still higher than they were there at just about at any other point in the pandemic. National case counts in the 60,000 range as opposed to the, say, 20,000 range mean that many more people will suffer severe outcomes from the coronavirus. And while death counts have dropped dramatically from the more than 3,000 people taken daily in the United States in stretches of January and February, the progress has been stalled at more than 700 deaths per day. The hope is that if case counts continue to fall over the coming weeks, deaths will follow in turn.

Already, the rollout of vaccines has dramatically changed the dynamics of the U.S. epidemic. Hospitalization and death rates among older adults the population with the highest immunization coverage have plummeted, while hospitalizations among younger adults have also started to come down more recently. Whereas for the first year of the pandemic hospitalizations and deaths would follow case counts in predictable patterns, experts now speak of vaccines decoupling those metrics because they are so powerfully protective against the worst outcomes of the disease.

But the shots arent just protecting individuals. Increasing evidence shows that they take a substantial bite out of transmission once theyre given to a certain swath of the population, as countries like Israel that have vaccinated most of their populations have demonstrated. Its not a specific threshold it will vary place to place depending on other factors but experts are hoping and anticipating that some places in the U.S. could be nearing that point, and drops in case counts could accelerate.

I think that might be whats happening in the Upper Midwest, said infectious disease physician Monica Gandhi of UCSF.

Experts had expected that the vaccine rollout would suppress Covid-19 come this summer, to such low levels that many of the activities weve forsaken over the past year could be done relatively safely.

But there was an intermediate hurdle: In some states, cases started rising again this spring, as politicians eased restrictions and individuals grew more relaxed. More transmissible variants of the coronavirus pushed cases up or slowed progress most notably B.1.1.7, which ignited major outbreaks in the United Kingdom (where it first emerged) and then in other European countries. Some recent transmission in New York and New Jersey also seems to have been driven by another variant, B.1.526.

The declining case counts in Michigan and other states suggest we may be back on track.

Im hopeful for that, epidemiologist Stephen Kissler of Harvards T.H. Chan School of Public Health said about the U.S. dodging the full brunt of B.1.1.7. Im cautiously optimistic.

One reason is that the weather got warmer, which appears to have an impact on transmission both for behavioral reasons (people spend more time outdoors) and perhaps for biological ones (many respiratory viruses lose some of their transmission efficiency in hotter, more humid temperatures). B.1.1.7-fueled spikes in the U.K. and Europe were exacerbated because they occurred over the colder months, for example.

The U.S. also had a big wall of natural immunity blunting just how widely the virus could spread this spring. Experts estimate that more than 100 million people in the country have recovered from an infection the vast majority of whom remain protected against reinfection for now.

And then, of course, vaccines. More than half of adults in the U.S. have received at least one dose of a vaccine, and a full third of adults are fully vaccinated.

The factors that spur outbreaks or slow them the weather, the number of susceptible people, the virus itself, the precautions people take can compound or counteract each other, and the plateaued national case count in recent weeks is a reflection of an almost even tug-of-war. But it appears that the balance in more places appears to be tilting toward declines.

Our optimism that the country as a whole has reached a clear turning point is further reinforced, modelers at Childrens Hospital of Philadelphias PolicyLab wrote in their latest update on Wednesday. This is great news for a Covid-weary nation, but we are mindful that the rates of improvement for some areas will be quicker than others.

For all the progress achieved with vaccines, the U.S. is reaching the point where supply is outpacing demand in a growing number of communities. The average number of daily vaccines administered reached a peak of nearly 3.2 million earlier this month, but has since fallen to 2.8 million, even as all people 16 and up became eligible for the shots. Its a matter of both access and hesitancy, and health officials at every level will increasingly have to reach people where they are or assuage their concerns to get more shots in arms. The University of Michigans Malani, for example, raised the concern that teens and young adults could drive outbreaks if theyre not incentivized to get vaccinated.

Experts still foresee a summer when vacations and barbecues return. The coronavirus wont be gone from the United States, but at what level it circulates and how much damage it inflicts in large part depends on how many people in each area remain unvaccinated. (Most children still wont be vaccinated this summer, but experts say that high levels of vaccine coverage among adults and lower transmission rates generally will reduce spread among children as well. Children overall are far less vulnerable to severe outcomes from Covid-19 than older adults, and appear to transmit the virus at lower levels.)

One trend experts will be keeping an eye on this summer is if there are echoes of summer 2020. While the warmer weather gives states in the northern part of the country some breathing room, last summer brought large outbreaks in places like Texas and Florida, where summer temperatures drive people into air-conditioned indoors. If there are large pockets of people who remain susceptible to Covid-19 in those places, they could potentially see a repeat increase in cases if on a significantly smaller scale this summer.

Continued here:

States with springtime Covid-19 surges appear to have turned a corner - STAT

News Release

Friday, April 23, 2021

Enrollment begins at NIH Clinical Center.

A study assessing how people with immune system deficiencies or dysregulations respond to COVID-19 vaccination has begun enrolling participants at the National Institutes of Health Clinical Center in Bethesda, Maryland. The single-site study is led by researchers from the National Institute of Allergy and Infectious Diseases (NIAID) and aims to enroll 500 people, 400 with primary or secondary immune system disorders and 100 without such conditions.

Through large Phase 3 trials, several experimental COVID-19 vaccines were shown to be safe and effective and three are now authorized by the U.S. Food and Drug Administration for emergency use in the United States, said NIAID Director Anthony S. Fauci M.D. People with immune disorders are typically excluded from trials of experimental vaccines, and this was the case in the COVID-19 vaccine trials. This new study will characterize the features and adequacy of immune responses to COVID-19 vaccination in people with a range of immune deficiencies and dysregulation syndromes and will provide valuable information about benefits and potential risks in these individuals.

In addition to analyzing how they respond to vaccination, the study team will gather information about COVID-19 illness in people with immune deficiencies and dysregulation conditions.

Currently, there are few published studies on the incidence and clinical presentation of COVID-19 disease in people who have immune deficiencies, especially those who have inborn conditions involving deficits or dysregulations in antibody or cell-based immune responses to infections, said study principal investigator Emily Ricotta, Ph.D., MSc, of the NIAID Laboratory of Clinical Immunology and Microbiology. Our study aims to fill this knowledge gap.

Potential volunteers may be identified and invited to join the new study through existing NIH study protocol pools of healthy volunteers or via existing protocols involving persons with immune system disorders. Healthcare providers also may refer their patients with immune deficiencies or dysregulation conditions for enrollment. Initially, the study will enroll participants 16 years of age and older. If COVID-19 vaccines are authorized for use in younger people in the future, the enrollment age criterion could expand to include them.

All study visits can be conducted either in person at the NIH Clinical Center or remotely. Participants may be enrolled if they are completely or partially vaccinated against COVID-19. If a volunteer has not yet been vaccinated, they will provide a blood sample to investigators seven days prior to receipt of an FDA-authorized COVID-19 vaccine. Study participants can receive any authorized COVID-19 vaccine in their local communities. Depending on which manufacturers vaccine a participant receives, additional blood samples will be collected between 14 and 28 days after the first dose. Participants who receive vaccine that is administered as a two-dose regimen will provide an additional blood sample between 21 and 28 days after the second vaccine dose. Participants who receive the one-dose Johnson & Johnson COVID-19 vaccine will provide a single blood sample between 21 and 28 days after vaccination.

Blood sampled before and shortly after vaccination will be used to study short-term immunological effects of immunization. Participants have the option to provide additional samples approximately six, 12 and 24 months after the last dose. These samples will permit the researchers to assess the persistence of vaccine-induced antibodies and T-cell responses and to compare responses made by people with and without immune system disorders. If vaccine booster injections are recommended in the future, volunteers may choose to provide additional blood samples following those booster vaccines.

At enrollment, participants will be asked if they have been diagnosed with COVID-19 in the past and about symptom severity, using standardized questionnaires.

This will allow us to characterize the different manifestations of COVID-19 illness in the study population and to determine what influence these may have on the immune response to COVID-19 vaccination, said Dr. Ricotta.

Participants also will have the option to be screened for SARS-CoV-2 infections following vaccination using at-home saliva collection kits that they will return to the NIH biweekly for six months. (SARS-CoV-2 is the virus that causes COVID-19.) During multiple follow-up timepoints in the trial, participants will be asked about any vaccine-related adverse events, which will allow the study team to better understand safety and tolerability of the vaccines in people with specific immune deficiency or dysregulation disorders.

The information we gather on how well COVID-19 vaccines protect these specific populations and about any adverse events experienced by those with immune dysregulation or other disorders will aid decision-making about vaccination, said Steven Holland, M.D., director of the NIAID Division of Intramural Research, and the studys medically responsible principal investigator.

More information about the study is available at clinicaltrials.gov by searching on the identifier NCT04852276. Study staff may also be contacted by those interested in participating at NIAIDcovidvaccinestudy@niaid.nih.gov.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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COVID-19 vaccine responses to be studied in people with immune deficits - National Institutes of Health

News Release

Wednesday, April 21, 2021

A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19. The trial, ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The therapeutic was developed by SAB Biotherapeutics, Inc. (Sioux Falls, South Dakota).

NIHs Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol designed for evaluating multiple investigational agents in adults with mild-to-moderate COVID-19 who are not hospitalized. Led by the NIAID-funded AIDS Clinical Trials Group (ACTG) and supported by PPD (Wilmington, North Carolina), a global contract research organization that is responsible for trial execution, the trial will enroll participants at sites around the world.

The ACTIV-2 study design allows researchers to evaluate SAB-185 in a small group of volunteers and then continue testing it in a larger group if the antibody appears safe and effective. The trial began on Aug. 4, 2020 and has since added several therapeutics for testing.

SAB-185 is a fully-human polyclonal antibody therapeutic candidate for COVID-19 that has completed enrollment of Phase 1 and Phase 1b clinical studies. In previous pre-clinical studies, SAB-185 demonstrated neutralization of live SARS-CoV-2 at titers higher than convalescent plasma. The therapeutic candidate was developed from SABs platform, which uses genetically engineered cattle to produce fully-human antibodies in a process designed to potentially be both scalable and reliable.SAB-185 is administered intravenously, with the dose depending on the patients weight in kilograms (kg). A high and a low dose of SAB-185 will be tested in this trial.

When participants enroll in ACTIV-2, they will be assigned at random to receive either SAB-185, another therapeutic currently being evaluated in ACTIV-2, or a placebo. Other therapeutics currently being evaluated in ACTIV-2 include:

In the Phase 2 evaluation, each agent tested in ACTIV-2, and the shared placebo group, will enroll 110 participants with mild or moderate COVID-19 who are at risk for disease progression. The trial is blinded, so neither participants nor investigators will know whether a participant is receiving the therapeutic or the placebo. Participants will attend a series of clinic or at-home visits by clinicians and will be followed for a total of 72 weeks.

An independent Data and Safety Monitoring Board (DSMB) overseeing the trial will review the data collected at 28 days. They will monitor data to see if the therapy is safe, reduces the duration of COVID-19 symptoms and eliminates virus from the body. If there are no serious safety concerns and the results of this Phase 2 study seem promising, the trial will transition to Phase 3. It will then enroll 421 additional volunteers to receive the SAB agent, and 421 volunteers in the placebo group. The primary objective of the Phase 3 trial is to determine if the SAB therapy prevents either hospitalization or death by 28 days after study entry.

The study team for ACTIV-2 is led by protocol chairs Kara W. Chew, M.D., of the University of California, Los Angeles (UCLA), and Davey Smith, M.D., of the University of California, San Diego. Eric S. Daar, M.D., of UCLA, and David Wohl, M.D., of the University of North Carolina at Chapel Hill (UNC), serve as protocol vice-chairs. Babafemi Taiwo, MBBS of Northwestern University is a co-investigator focused on the SAB agent. The ACTG network is led by chair Judith Currier, M.D., (UCLA) and vice-chair Joseph Eron, M.D., of UNC.

For more information on this study, please visit http://www.riseabovecovid.org, or visit clinicaltrials.gov and search identifier NCT04518410.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Large NIH clinical trial will test polyclonal antibody therapeutic for COVID-19 - National Institutes of Health