As your partner in health and safety, we are continuously monitoring regulatory updates that may affect your operations. See the NIH's latest COVID-19 updates and resources below.

NIH Begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19

The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications.

The clinical trial aims to determine if modulating that immune response can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system.

https://www.nih.gov/news-events/news-releases/nih-begins-large-clinical-trial-test-immune-modulators-treatment-covid-19

NIH Study Aims to Identify Promising COVID-19 Treatments for Larger Clinical Trials

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials.

The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized with COVID-19 at as many as 40 U.S sites, is being conducted in collaboration with the NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovation and Vaccines (ACTIV) program.

https://www.nih.gov/news-events/news-releases/nih-study-aims-identify-promising-covid-19-treatments-larger-clinical-trials

NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins

A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral Remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun.

The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC.

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-testing-hyperimmune-intravenous-immunoglobulin-plus-remdesivir-treat-covid-19-begins

NIH RADx Initiative Advances Six New COVID-19 Testing Technologies

The National Institutes of Health, working in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), announced a third round of contract awards for scale-up and manufacturing of new COVID-19 testing technologies. The six new Rapid Acceleration of Diagnostics (RADx) initiative contracts total $98.35 million for point-of-care and other novel test approaches that provide new modes of sample collection, processing and return of results. Innovations in these new technologies include integration with smart devices, mobile-lab processing that can be deployed to COVID-19 hot spots, and test results available within minutes.

https://www.nih.gov/news-events/news-releases/nih-radx-initiative-advances-six-new-covid-19-testing-technologies

NIH to Assess and Expand COVID-19 Testing for Underserved Communities

The National Institutes of Health has awarded nearly $234 million to improve COVID-19 testing for underserved and vulnerable populations. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program will support 32 institutions across the United States and will focus on populations disproportionately affected by the pandemic. These groups include African Americans, American Indians/Alaskan Natives, Latinos/Latinas, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated.

“It is critical that all Americans have access to rapid, accurate diagnostics for COVID-19, especially underserved and vulnerable populations who are bearing the brunt of this disease,” said NIH Director Francis S. Collins, M.D., Ph.D. “The RADx-UP program will help us better understand and alleviate the barriers to testing for those most vulnerable and reduce the burden of this disease.”

https://www.nih.gov/news-events/news-releases/nih-assess-expand-covid-19-testing-underserved-communities

Investigational COVID-19 Vaccine Well-tolerated and Generates Immune Response in Older Adults

A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.

The experimental vaccine, mRNA-1273, was co-developed by researchers at NIAID and Moderna, Inc. of Cambridge, Massachusetts. The Phase 1 trial began on March 16, 2020 and was expanded to enroll older adults about one month later. Older adults are more vulnerable to complications of COVID-19 and are an important population for vaccination. Understanding how the vaccine affects older adults is a critical part of measuring its safety and efficacy.

https://www.nih.gov/news-events/news-releases/investigational-covid-19-vaccine-well-tolerated-generates-immune-response-older-adults

Scientists Discover Genetic and Immunologic Underpinnings of Some Cases of Severe COVID-19

New findings help explain why some people with COVID-19 develop severe disease and may provide the first molecular explanation for why more men than women die from COVID-19. The researchers found that more than 10% of people who develop severe COVID-19 have misguided antibodies―autoantibodies―that attack the immune system rather than the virus that causes the disease. Another 3.5% or more of people who develop severe COVID-19 carry a specific kind of genetic mutation that impacts immunity. Consequently, both groups lack effective immune responses that depend on type I interferon, a set of 17 proteins crucial for protecting cells and the body from viruses.

https://www.nih.gov/news-events/news-releases/scientists-discover-genetic-immunologic-underpinnings-some-cases-severe-covid-19

NIH Expands Clinical Trials to Test Convalescent Plasma Against COVID-19

Rigorous Studies to Build on Earlier Efforts to Test the Experimental Treatment

Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19.

https://www.nih.gov/news-events/news-releases/nih-expands-clinical-trials-test-convalescent-plasma-against-covid-19

Fourth Large-Scale COVID-19 Vaccine Trial Begins in the United States

Trial Evaluating Investigational Janssen COVID-19 Vaccine

A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.

https://www.nih.gov/news-events/news-releases/fourth-large-scale-covid-19-vaccine-trial-begins-united-states

NIH Awards Contracts to Develop Innovative Digital Health Technologies for COVID-19

The National Institutes of Health has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals.

https://www.nih.gov/news-events/news-releases/nih-awards-contracts-develop-innovative-digital-health-technologies-covid-19

Substance Use Disorders Linked to COVID-19 Susceptibility

A National Institutes of Health-funded study found that people with substance use disorders (SUDs) are more susceptible to COVID-19 and its complications. The research, published in Molecular Psychiatry, was co-authored by Nora D. Volkow, M.D., director of the National Institute on Drug Abuse (NIDA). The findings suggest that health care providers should closely monitor patients with SUDs and develop action plans to help shield them from infection and severe outcomes.

https://www.nih.gov/news-events/news-releases/substance-use-disorders-linked-covid-19-susceptibility

NIH ACTIV Initiative Launches Adaptive Clinical Trials of Blood-Clotting Treatments for COVID-19

The National Institutes of Health has launched two of three adaptive Phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, these trials will be conducted at more than 100 sites around the world and will involve patients in various clinical settings—those who have not been hospitalized, those currently hospitalized and those discharged after hospitalization for moderate to severe disease.

Collectively known as ACTIV-4 Antithrombotics, the trials will provide critical insights that could help guide the care of patients with COVID-19, particularly those who suffer from life-threatening blood clots. The trial for hospitalized COVID-19 patients and the trial for patients with COVID-19 who have not been hospitalized are now underway. A third trial to start later will focus on patients discharged after hospitalization for moderate to severe COVID-19 disease. All three clinical trials will be coordinated and overseen by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, and funded through Operation Warp Speed.

https://www.nih.gov/news-events/news-releases/nih-activ-initiative-launches-adaptive-clinical-trials-blood-clotting-treatments-covid-19

NIH Continues to Boost National COVID-19 Testing Capacity

The National Institutes of Health today announced $129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. These tests add to initial awards made to seven companies on July 31, 2020.

https://www.nih.gov/news-events/news-releases/nih-continues-boost-national-covid-19-testing-capacity

NIH-Supported Study to Track Prevalence and Impact of SARS-CoV-2 Among Pregnant Women in Low- and Middle-Income Countries

The National Institutes of Health has launched a study to track the prevalence and impact of SARS-CoV-2 infection among approximately 16,000 pregnant women in seven low- and middle-income countries. The study will follow women through pregnancy and 12 months after childbirth to compare maternal, fetal and newborn outcomes of participants who have been infected with the virus to those of pregnant women who have not been infected. At delivery, women enrolled in the study will receive an antibody test to determine if they have been exposed to SARS-CoV-2. Researchers hope to determine if infection increases the risk of complications such as preterm birth, fetal growth restriction, stillbirth, newborn death and birth defects. They also hope to assess participants’ knowledge and attitudes of COVID-19 during pregnancy, including safety, protective practices and prenatal care. Women in the study will also be invited to participate in a follow-up analysis to determine if maternal SARS-CoV-2 infection influences infant outcomes such as cerebral palsy, developmental delays and hearing and vision abnormalities.

https://www.nih.gov/news-events/news-releases/nih-supported-study-track-prevalence-impact-sars-cov-2-among-pregnant-women-low-middle-income-countries

Phase 3 Clinical Testing in the US of AstraZeneca COVID-19 Vaccine Candidate Begins

A multi-site, Phase 3 clinical trial evaluating an investigational COVID-19 vaccine known as AZD1222 has begun. The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to evaluate if the candidate vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19). The United Kingdom-based global biopharmaceutical company AstraZeneca is leading the trial as regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are providing funding support for the trial.

https://www.nih.gov/news-events/news-releases/phase-3-clinical-testing-us-astrazeneca-covid-19-vaccine-candidate-begins

Clinical Trials of Monoclonal Antibodies to Prevent COVID-19 Now Enrolling

NIH reported that two Phase 3, randomized, placebo-controlled, double-blind clinical trials testing whether experimental monoclonal antibodies (mAbs) can prevent infection by SARS-CoV-2 coronavirus are now enrolling healthy adults at clinical trial sites in the United States. Many of the trial sites and study investigators are part of the COVID-19 Prevention Network (CoVPN), recently established by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. The trials are enrolling adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection.

https://www.nih.gov/news-events/news-releases/clinical-trials-monoclonal-antibodies-prevent-covid-19-now-enrolling

NIH-Funded Project Seeks to Identify Children at Risk for MIS-C

The National Institutes of Health has announced research funding to encourage the development of approaches that identify children at high risk for developing Multisystem Inflammatory Syndrome in Children (MIS-C), thought to be a severe complication of COVID-19. Most children exposed to or infected with SARS-CoV-2, the virus that causes COVID-19, develop only a mild form of the illness. However, others go on to develop MIS-C, a severe, sometimes fatal, inflammation of organs and tissues, including the heart, lungs, kidneys, brain, skin and eyes. The new effort seeks to encourage studies of genetic, immune, viral, environmental, and other factors that influence how severe a case of COVID-19 will be and the chances of developing to MIS-C.

https://www.nih.gov/news-events/news-releases/nih-funded-project-seeks-identify-children-risk-mis-c

  

NIH Clinical Trial Testing Remdesivir Plus Interferon Beta-1a for COVID-19 Treatment Begins

The National Institutes of Health announced that a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen consisting of the antiviral remdesivir plus the immunomodulator interferon beta-1a in patients with coronavirus disease 2019 (COVID-19) has begun. The study, called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the United States and abroad. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial. ACTT 3 is the third iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT). ACTT began on Feb. 21 to evaluate remdesivir, an investigational broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc, of Foster City, California. A preliminary analysis of ACTT data found that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo. These results were published on May 22. More detailed information about the results, including more comprehensive data, will be available in a forthcoming report.

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-testing-remdesivir-plus-interferon-beta-1a-covid-19-treatment-begins

NIH-Moderna Investigational COVID-19 Vaccine Shows Promise in Mouse Studies

NIH reported that the investigational vaccine known as mRNA-1273 protected mice from infection with SARS-CoV-2, the virus that causes COVID-19, according to research published in Nature. Scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the biotechnology company Moderna, based in Cambridge, Massachusetts, along with collaborators from the University of North Carolina at Chapel Hill, Vanderbilt University Medical Center in Nashville, and the University of Texas at Austin conducted the preclinical research. NIAID Vaccine Research Center (VRC) scientists worked with investigators from the University of Texas at Austin to identify the atomic structure of the spike protein on the surface of the novel coronavirus. This structure was used by VRC and Moderna in the development of the vaccine candidate.

https://www.nih.gov/news-events/news-releases/nih-moderna-investigational-covid-19-vaccine-shows-promise-mouse-studies

  

NIH Harnesses AI for COVID-19 Diagnosis, Treatment, and Monitoring

NIH reported that they have launched the Medical Imaging and Data Resource Center (MIDRC), an ambitious effort that will harness the power of artificial intelligence and medical imaging to fight COVID-19. The multi-institutional collaboration, led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of NIH, will create new tools that physicians can use for early detection and personalized therapies for COVID-19 patients.

https://www.nih.gov/news-events/news-releases/nih-harnesses-ai-covid-19-diagnosis-treatment-monitoring

NIH Clinical Trial to Test Antibodies and Other Experimental Therapeutics for Mild and Moderate COVID-19

NIH reported that a Phase 2 clinical trial will evaluate the safety and efficacy of potential new therapeutics for COVID-19, including an investigational therapeutic based on synthetic monoclonal antibodies (mAbs) to treat the disease. Researchers sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are working with clinical sites to identify potential patient volunteers currently infected with SARS-CoV-2, the virus which causes COVID-19, who have mild to moderate disease not requiring hospitalization. They will be invited to take an experimental therapy or a placebo as part of a rigorously designed randomized clinical trial. The trial, which is known as ACTIV-2, also may investigate other experimental therapeutics later under the same trial protocol.

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-test-antibodies-other-experimental-therapeutics-mild-moderate-covid-19

  

NIH Launches Clinical Trial to Test Antibody Treatment in Hospitalized COVID-19 Patients

The NIH reported that patients admitted with COVID-19 at select hospitals may now volunteer to enroll in a clinical trial to test the safety and efficacy of a potential new treatment for the disease. The Phase 3 randomized, controlled trial is known as ACTIV-3, and as a “master protocol,” it is designed to expand to test multiple different kinds of monoclonal antibody treatments. It also can enroll additional volunteers in the middle of the trial, if a specific investigational treatment shows promise.

https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trial-test-antibody-treatment-hospitalized-covid-19-patients

NIH Delivering New COVID-19 Testing Technologies to Meet U.S. Demand

The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing (which detects SARS-CoV-2 coronavirus). NIH’s Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020. With national demand estimated to be millions more tests per day above current levels, these technologies are expected to make a significant contribution to expanding the nation’s testing capacity.

https://www.nih.gov/news-events/news-releases/nih-delivering-new-covid-19-testing-technologies-meet-us-demand

Experimental COVID-19 Vaccine Protects Upper and Lower Airways in Nonhuman Primates

Scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health reported that two doses of an experimental vaccine to prevent coronavirus disease 2019 (COVID-19) induced robust immune responses and rapidly controlled the coronavirus in the upper and lower airways of rhesus macaques exposed to SARS-CoV-2.

https://www.nih.gov/news-events/news-releases/experimental-covid-19-vaccine-protects-upper-lower-airways-nonhuman-primates

Phase 3 Clinical trial of Investigational Vaccine for COVID-19 Begins

NIH reported that a phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. The vaccine, known as mRNA-1273, was co-developed by a Cambridge, Massachusetts-based biotechnology and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial, which will be conducted at US clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.

https://www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins

NIH Leadership Details Unprecedented Initiative to Ramp Up Testing Technologies

In a paper in the New England Journal of Medicine, scientific leaders from the National Institutes of Health set forth a framework to increase significantly the number, quality and type of daily tests for detecting SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations that have been disproportionally affected by the disease. To fill this urgent need, the Rapid Acceleration of Diagnostics (RADx) program was established. The four major components of the RADx are listed in full detail at the following link:

https://www.nih.gov/news-events/news-releases/nih-leadership-details-unprecedented-initiative-ramp-testing-technologies-covid-19

Experimental COVID-19 Vaccine Safe, Generates Immune Response

An investigational vaccine, mRNA-1273, designed to protect against SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), was generally well tolerated and prompted neutralizing antibody activity in healthy adults, according to interim results published online today in The New England Journal of Medicine. The experimental vaccine is being co-developed by researchers at NIAID and at Moderna, Inc. of Cambridge, Massachusetts. Manufactured by Moderna, mRNA-1273 is designed to induce neutralizing antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells. A Phase 2 clinical trial of mRNA-1273, began enrollment in late May. Plans are underway to launch a Phase 3 efficacy trial in July 2020.

https://www.nih.gov/news-events/news-releases/experimental-covid-19-vaccine-safe-generates-immune-response

  

Placenta Lacks Major Molecules Used by SARS-CoV-2 Virus to Cause Infection

The placental membranes that contain the fetus and amniotic fluid lack the messenger RNA (mRNA) molecule required to manufacture the ACE2 receptor, the main cell surface receptor used by the SARS-CoV-2 virus to cause infection, according to a study by researchers at the National Institutes of Health. Their findings appear in the journal eLife.

https://www.nih.gov/news-events/news-releases/placenta-lacks-major-molecules-used-sars-cov-2-virus-cause-infection

NIH Launches Clinical Trials Network to Test COVID-19 Vaccines

The COVID-19 Prevention Trials Network (COVPN) was established to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19. People also can learn more about the different stages of vaccine research and the new network’s COVID-19 vaccine and monoclonal antibody studies by visiting the COVPN’s website. The first Phase 3 clinical trial that the COVPN is expected to conduct will involve testing the investigational mRNA-1273 vaccine, developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. That study is expected to begin this summer.

https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trials-network-test-covid-19-vaccines-other-prevention-tools

Vaccine Working Group Weighs Role of Human Challenge Studies for SARS-CoV-2 Vaccine Development

Experts determine a timeline for developing robust Controlled Human Infection Model (CHIM) that meets the essential criteria for limiting risk for study volunteers could take one to two years. Members of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group assess practical considerations and prerequisites for using controlled human infection models, which can be used for human challenge studies, to support SARS-CoV-2 vaccine development. In a CHIM study, participants are intentionally exposed to an infectious agent to help scientists understand the virus or test interventions to prevent or treat infection. CHIMs use well-characterized microorganisms that either do not cause serious disease, are easily treated, or both. In addition, CHIM studies must take place in laboratories with rigorous isolation to ensure that the infection does not spread into the community.

https://www.nih.gov/news-events/news-releases/nih-activ-working-group-weighs-role-human-challenge-studies-sars-cov-2-vaccine-development

Steps to Expand and Improve Antibody Tests

More than 300 scientists and clinicians that were NIH workshop attendees reviewed capabilities and limits of SARS-CoV-2 serology testing. Attendees recommended that additional research is needed to determine if and to what extent a positive antibody test means a person may be protected from reinfection with SARS-CoV-2. Attendees emphasized that until such data is available, serology tests should not be used as a stand-alone tool to make decisions about personal safety related to SARS-CoV-2 exposure. Researchers are now pursuing studies in humans and in animal models to better understand SARS-CoV-2 immunity. Attendees noted that such understanding could help identify optimal donors of convalescent plasma that potentially could be used to help treat those with severe COVID-19.

https://www.nih.gov/news-events/news-releases/experts-identify-steps-expand-improve-antibody-tests-covid-19-response

Broad Spectrum Infectious Diseases Immunotherapy Study Shows Promise

National Institutes of Health investigators and colleagues have discovered that when the immune system first responds to infectious agents such as viruses or bacteria, a natural brake on the response prevents overactivation. Their new study in mBio describes this brake and the way pathogens such as SARS-CoV-2, the virus that causes COVID-19, turn it on.

https://www.nih.gov/news-events/news-releases/nih-investigators-hope-cd47-study-leads-broad-spectrum-infectious-diseases-immunotherapy

Experts Identify Steps to Expand and Improve Antibody Tests in COVID-19 Response

More than 300 scientists and clinicians from the federal government, industry and academia published a report of their conclusions and recommendations on COVID-19 serology studies online in Immunity. While such tests do not diagnose active infection, they can indicate prior infection with SARS-CoV-2 that may have been missed because a person did not experience significant symptoms or access testing while infected. Attendees recommended that additional research is needed to determine if and to what extent a positive antibody test means a person may be protected from reinfection with SARS-CoV-2. Attendees emphasized that until such data is available, serology tests should not be used as a stand-alone tool to make decisions about personal safety related to SARS-CoV-2 exposure.

https://www.nih.gov/news-events/news-releases/experts-identify-steps-expand-improve-antibody-tests-covid-19-response

NIH Halts Clinical Trial of Hydroxychloroquine

A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has been stopped by the National Institutes of Health. A data and safety monitoring board (DSMB) met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19.

https://www.nih.gov/news-events/news-releases/nih-halts-clinical-trial-hydroxychloroquine

Leveraging Existing Program for Antibody Testing

The All of Us Research Program, part of the National Institutes of Health, today announced that it is leveraging its significant and diverse participant base to seek new insights into COVID-19—through antibody testing, a survey on the pandemic’s impacts and collection of electronic health record information. All of Us will test blood samples from 10,000 or more participants who joined the program most recently, starting with samples from March 2020 and working backward until positive tests are no longer found. The tests will show the prevalence of novel coronavirus exposure among All of Us participants, and help researchers assess varying rates across regions and communities.

https://www.nih.gov/news-events/news-releases/all-us-research-program-launches-covid-19-research-initiatives

Analytics Platform for Nationwide COVID-19 Patient Data

The NIH has launched National COVID Cohort Collaborative (N3C), centralized, secure enclave to store and study vast amounts of medical record data from people diagnosed with coronavirus disease across the country. It is designed to help scientists analyze these data to understand the disease and develop treatments. Data access will be open to all approved users, regardless of whether they contribute data. The data are being provided to NCATS as a Limited Data Set (LDS) that retains only 2 of 18 HIPAA-defined elements: health care provider zip code and dates of service.

https://www.nih.gov/news-events/news-releases/nih-launches-analytics-platform-harness-nationwide-covid-19-patient-data-speed-treatments

Researchers Identify Key Genomic Features of CoV-2

A team of researchers identified genomic features of SARS-CoV-2, and other high-fatality coronaviruses that distinguish them from other members of the coronavirus family. The difference in features include insertions of specific stretches of amino acids into two virus proteins, the nucleocapsid and the spike. These features are found in all three high-fatality coronaviruses and their closest relatives that infect animals, such as bats, but not in four other human coronaviruses that cause non-fatal disease. Implications include potential targets for diagnostics and therapies.

https://www.nih.gov/news-events/news-releases/nih-researchers-identify-key-genomic-features-could-differentiate-sars-cov-2-other-coronaviruses-cause-less-severe-disease

Study to Evaluate Drugs Prescribed to Children with COVID-19

Researchers funded by the National Institutes of Health have launched an effort to evaluate drugs prescribed to treat COVID-19 in infants, children and adolescents across the country. The study leverages an existing clinical trial that examines drugs that are prescribed off-label to children for a variety of medical conditions. Products will be added or removed from the list as researchers learn more about the treatment needs of patients with COVID-19. The study is not a clinical trial with a control group. Rather, healthcare providers who are already treating patients with drugs on the list may enroll patients whose parents or guardians have given their consent.

https://www.nih.gov/news-events/news-releases/nih-funded-study-evaluate-drugs-prescribed-children-covid-19

Potential Treatment Approach for Severe COVID-19 Cases

Early data from a clinical study suggest that blocking the Bruton tyrosine kinase (BTK) protein provided clinical benefit to a small group of patients with severe COVID-19. Researchers observed that the off-label use of the cancer drug Acalabrutinib, a BTK inhibitor that is approved to treat several blood cancers, was associated with reduced respiratory distress and a reduction in the overactive immune response in most of the treated patients. These findings should not be considered clinical advice but are being shared to assist the public health response to COVID-19.

https://www.nih.gov/news-events/news-releases/study-identifies-potential-approach-treat-severe-respiratory-distress-patients-covid-19

Remdesivir Improves COVID-19 Time to Recovery

A study published in the New England Journal of Medicine found that patients with moderate to severe COVID-19 that were hospitalized and required oxygen discharged from the hospital on average 4 days earlier than those given placebo (11 days instead of 15 days). Trial results also suggested a survival benefit with a 14-day mortality rate of 7.1% in the group receiving remdesivir versus 11.9% for the placebo group; however, the difference in mortality was not statistically significant for the sample size of 1,063 total patients enrolled.

J Beigel, et al. Remdesivir for the Treatment of COVID-19 – A Preliminary Report. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2007764 (2020).

https://www.nih.gov/news-events/news-releases/peer-reviewed-data-shows-remdesivir-covid-19-improves-time-recovery

Pregnancy Study During COVID-19

Researchers will analyze the medical records of up to 21,000 women to evaluate whether changes to healthcare delivery that were implemented as a result of the pandemic have led to higher rates of pregnancy-related complications and cesarean delivery.

https://www.nih.gov/news-events/news-releases/nih-funded-study-investigate-pregnancy-outcomes-resulting-covid-19-pandemic

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

Released a statement describing the initiative referred to Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). Which is a public-private initiative designed to coordinate at least 18 leading biopharmaceutical companies, multiple US Federal agencies, and the European Medicines Agency to developing an international strategy for an integrated research response to COVID-19. Four working groups have been established:

  • Preclinical group to standardized evaluation resources and methods
  • Therapeutics Clinical group to prioritize and accelerate clinical evaluation of therapeutic candidates
  • Clinical trial capacity to assemble and coordinate existing networks of clinical trials.
  • Vaccines group to accelerate and evaluate vaccine candidates

https://www.nih.gov/news-events/news-releases/nih-director-defeating-covid-19-requires-unprecedented-action-collaboration

Investigational Vaccine Protects Monkeys Against COVID-19 Pneumonia

University of Oxford researchers developed first vaccine using existing methods but applying SARS-CoV-2 protein. The vaccine was tested with six rhesus monkeys provided adequate immune response to prevent illness when compared to 3 control monkeys that were not given the vaccine.

https://www.nih.gov/news-events/news-releases/investigational-chadox1-ncov-19-vaccine-protects-monkeys-against-covid-19-pneumonia

Coordinated Strategy to Accelerate Multiple COVID-19 Vaccine Candidates is Key, NIH Experts Say

Scientific leaders published in Science a likely path toward vaccine for COVID-19 that includes:

  • No single vaccine or vaccine platform is likely to meet the global need
  • Researchers need to learn more about how to ensure the vaccine actually protects against COVID-19
  • Significant manufacturing capacity will be required to produce the vaccine for worldwide consumption
  • Collaboration will be essential

https://www.nih.gov/news-events/news-releases/coordinated-strategy-accelerate-multiple-covid-19-vaccine-candidates-key-nih-experts-say

  

NIH Begins Clinical Trial of Hydroxychloroquine and Azithromycin to Treat COVID-19

Clinical Trial paring the malaria drug hydroxychloroquine and the antibiotic azithromycin to prevent hospitalization and death has begun. A Phase 2b trial will enroll 2000 adults with confirmed SARS-CoV-2 infection and fever, cough and/or shortness of breath. Participants will take either placebo or medication at home and report symptoms/hospitalizations to researches for the next 20 days. FDA cautions that use of hydroxychloroquine has rare risk of life-threatening heart rhythm problems and should only be used for COVID-19 patients in the clinical trial.

https://www.nih.gov/news-events/news-releases/nih-begins-clinical-trial-hydroxychloroquine-azithromycin-treat-covid-19

NIH Study to Determine Incidence of COVID-19 in Children Begins

Remote surveys of 6,000 children in 2,000 families are designed to increase understanding of full extent of infection in the entire population, and how it manifests in children and spreads to family members.

https://www.nih.gov/news-events/news-releases/study-determine-incidence-novel-coronavirus-infection-us-children-begins

NIH Released a Strategic Plan to Accelerate Research to Diagnose, Prevent, and Treat COVID-19

The plan has a four-pronged approach:

  • Understand the SARS-CoV-2 Virus and resulting COVID-19 illness including transmission surveillance and the role of asymptomatic individuals in viral spread.
  • Development of rapid diagnostics to identify new cases, as well as individuals who may have had an infection and recovered. (see “Diagnostics Innovation Initiative” below).
  • The testing of treatments for the illness by identifying and evaluating drugs already approved for other conditions.
  • Development of safe and effective vaccines to protect individuals from infection and future outbreaks.

https://www.nih.gov/news-events/news-releases/niaid-strategic-plan-details-covid-19-research-priorities

  

NIH Diagnostics Innovation Initiative

The Diagnostics Innovation Initiative is a call to all scientists and inventors with rapid testing technology to compete in the national COVID-19 testing challenge for a share of up to $500M over all phases of development. The goal is to rapidly develop at-home or point-of-care tests.

https://www.nih.gov/news-events/news-releases/nih-mobilizes-national-innovation-initiative-covid-19-diagnostics

The NIH published interim guidelines for the medical management of COVID-19.

People seeking information about registered clinical trials for COVID-19 in the US can search ClinicalTrials.gov.

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