August 10, 2020
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.
August 05, 2020
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.
August 05, 2020
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 today 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.
NIH Clinical Trial to Test Antibodies and Other Experimental Therapeutics for Mild and Moderate COVID-19
August 04, 2020
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.
August 04, 2020
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.
July 28, 2020
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, report scientists from 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.
July 27, 2020
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 the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.
July 24, 2020
Today the European Medicines Agency (EMA) announced it has adopted a positive scientific opinion on the dapivirine vaginal ring for use by cisgender women ages 18 and older in developing countries to reduce their risk of HIV infection. This milestone marks an important step toward expanding the number of biomedical HIV prevention options available to women in sub-Saharan Africa, who are among those most affected by the HIV epidemic.
July 23, 2020
Kidney transplantation from deceased donors with HIV to people living with both HIV and end-stage kidney disease is feasible and safe, investigators supported by the National Institutes of Health have found. Their study demonstrates that the pool of available kidneys for people with HIV can be expanded by including donors with HIV, making more kidneys available for all who are awaiting a transplant.
July 14, 2020
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 ongoing Phase 1 trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine is being co-developed by researchers at NIAID and at Moderna, Inc.
July 08, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has established a new clinical trials network that aims 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.
July 07, 2020
A pre-exposure prophylaxis (PrEP) regimen containing an investigational long-acting form of the HIV drug cabotegravir injected once every 8 weeks was more effective than daily oral Truvada at preventing HIV acquisition among cisgender men who have sex with men and transgender women who have sex with men in a clinical trial sponsored by the National Institutes of Health. While both methods were highly effective for HIV prevention in the study population, the final data analysis indicated that cabotegravir had a superior protective effect.
June 23, 2020
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. The group gathered for an online workshop in May to discuss the role of serology testing in understanding and responding to the COVID-19 public health crisis and to explore strategies to address key scientific knowledge opportunities and gaps in the emerging field.
June 23, 2020
NIH 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. Their finding provides a potential target for an immunotherapy that might be applied to a wide range of infectious diseases.
BULLETIN—NIH Clinical Trial Evaluating Hydroxychloroquine and Azithromycin for COVID-19 Closes Early
June 20, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has stopped enrollment in its clinical trial evaluating whether hydroxychloroquine and azithromycin can prevent hospitalization and death from coronavirus disease 2019 (COVID-19). This action was taken because NIAID, the study leadership and the independent data and safety monitoring board (DSMB) overseeing the trial determined that the rate of participant enrollment has been inadequate for the trial to meet its objectives in a timely manner.
May 22, 2020
The investigational antiviral remdesivir is superior to the standard of care for the treatment of COVID-19, according to a report published today in The New England Journal of Medicine. The preliminary analysis is based on data from the Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
May 18, 2020
An investigational long-acting form of the HIV drug cabotegravir injected once every 8 weeks safely and effectively prevents HIV acquisition in men who have sex with men and transgender women who have sex with men. This finding, from a planned interim analysis of study data, marks the first time a large-scale clinical trial has shown a systemic, long-acting form of HIV prevention to be highly effective.
May 15, 2020
A single dose of ChAdOx1 nCoV-19, an investigational vaccine against SARS-CoV-2, has protected six rhesus macaques from pneumonia caused by the virus, according to National Institutes of Health scientists and University of Oxford collaborators. SARS-CoV-2 is the virus that causes COVID-19. The researchers posted their data to the preprint server bioRxiv. The findings are not yet peer-reviewed but are being shared to assist the public health response to COVID-19.
May 14, 2020
A clinical trial has begun to evaluate whether the malaria drug hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from coronavirus disease 2019 (COVID-19). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG). Teva Pharmaceuticals is donating medications for the study.
May 11, 2020
A harmonized and collaborative approach to the clinical testing, scale-up and distribution of candidate vaccines to prevent COVID-19 is essential, scientific leaders write in a perspective published today in Science. As the COVID-19 pandemic continues, government, industry and academia have introduced a variety of vaccine candidates. The authors note that more than one effective vaccine approach likely will be required to successfully protect the global community from SARS-CoV-2, the virus that causes COVID-19.
NIH Clinical Trial Testing Antiviral Remdesivir Plus Anti-Inflammatory Drug Baricitinib for COVID-19 Begins
May 08, 2020
A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun. The trial is now enrolling hospitalized adults with COVID-19 in the United States. The trial is expected to open at approximately 100 U.S. and international sites. Investigators currently anticipate enrolling more than 1,000 participants.
May 05, 2020
Today on World Asthma Day, the National Institutes of Health stands with patients, families, advocates, researchers, and health care professionals to raise awareness about this common chronic respiratory disease, the people it affects, and the biomedical research that improves its prevention and treatment.
May 04, 2020
A study to help determine the rate of novel coronavirus infection in children and their family members in the United States has begun enrolling participants. The study, called Human Epidemiology and Response to SARS-CoV-2 (HEROS), also will help determine what percentage of children infected with SARS-CoV-2, the virus that causes COVID-19, develop symptoms of the disease. In addition, the HEROS study will examine whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not.
April 29, 2020
Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients, which began on February 21.
April 22, 2020
Urgent public health measures are needed to control the spread of the novel coronavirus (SARS-CoV-2) and the disease it causes, coronavirus disease 2019, or COVID-19. Scientific research to improve our understanding of the virus and how it causes disease, and to develop strategies to mitigate illness and death, is of paramount importance. A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.