University of California, Los Angeles (UCLA), Health Sciences

ACTG Launches Clinical Trial Testing Treatment for COVID-19

Study will Evaluate Hydroxychloroquine+Azithromycin among Adults with Mild to Moderate COVID-19 in the United States

 

Newswise — Los Angeles, Calif. – The AIDS Clinical Trials Group (ACTG), the world’s largest and longest established HIV research network, today announced the initiation of ACTG 5395, a clinical trial to evaluate whether the drug combination hydroxychloroquine and azithromycin can prevent hospitalization and death from COVID-19 (which is caused by infection with the virus SARS-CoV-2). There is currently no approved vaccine or therapeutic to prevent or treat COVID-19, which has been spreading worldwide since cases were first reported in December 2019 in Wuhan, Hubei Province, China. For information about enrolling in the trial, please email actg.communications@fstrf.org

“There is an urgent public health need to rapidly evaluate interventions to treat COVID-19, which has emerged as a global pandemic in recent months,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “Well-designed trials are needed to evaluate whether drugs that have been studied and used over many years to treat other conditions are effective against COVID-19. ACTG’s history of implementing a wide variety of clinical trials over the last 33 years positions us well to quickly execute this clinical trial and help determine whether hydroxychloroquine and azithromycin may be an effective treatment for COVID-19.” 

ACTG is conducting this double-blind, placebo-controlled, randomized phase 2b clinical trial at 31 of its U.S.-based sites (the list can be accessed here) and will enroll approximately 2,000 adults with COVID-19. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which also funds the ACTG. Participants will be randomized to orally receive one of two regimens. The first arm will receive a loading dose of hydroxychloroquine (400 mg twice a day on the first day), followed by 200 mg twice a day for six days, plus 500 mg of azithromycin on the first day, followed by 250 mg every day for four days. The second arm will receive matching placebos.

In order to qualify for the study, participants must have tested positive for SARS-CoV-2 infection in the outpatient setting and be experiencing at least one of the following symptoms: fever, cough, or shortness of breath. Eligible participants include people living with HIV, women who are pregnant, and those currently breastfeeding.

ACTG 5395 is being led by protocol chair Davey Smith, M.D. of the University of California, San Diego, along with David Wohl, M.D. of the University of North Carolina and Kara W. Chew M.D., M.S. and Eric S. Daar, M.D. of the University of California, Los Angeles.  

“Because the COVID-19 pandemic has been particularly devastating for people who are older and have underlying health issues, it is our goal that at least half of study participants will be members of these high-risk groups,” said Dr. Smith. “By ensuring meaningful representation of individuals who are 60 years and older or immunocompromised and those with chronic lung, kidney, and liver disease, severe obesity, hypertension, or diabetes, we are hopeful that we will gain important insights that will directly impact care for people with COVID-19.” 

As of May 14, 2020, the World Health Organization (WHO) has reported 4,218,212 cases and 290,242 related deaths worldwide. The United States became the epicenter of the epidemic on March 26, 2020, reporting more cases than any other country worldwide. As of May 13, 2020, the Centers for Disease Control and Prevention (CDC) has reported 1,364,061 cases and 82,246 related deaths in the United States. 

Hydroxychloroquine is currently approved for malaria treatment and prevention, as well as for the treatment of autoimmune conditions, including rheumatoid arthritis and lupus. Azithromycin is currently approved to treat bacterial infections, including sinusitis, community-acquired pneumonia, urethritis/cervicitis, pharyngitis, and acute exacerbations of COPD. While there has been some evidence that this drug combination may decrease viral loads among people with COVID-19, large, well-controlled clinical trials are needed to determine its true efficacy. The ACTG, with its ability to use existing sites and staff to rapidly conduct trials, is ideally positioned to conduct a major clinical trial among patients with COVID-19 (who currently have no proven treatment options) during this pandemic. 

For more information about ACTG 5395, visit www.actgnetwork.org or ClinicalTrials.gov using study identifier NCT04358068.

 

About the AIDS Clinical Trials Group

Founded in 1987, the AIDS Clinical Trials Group (ACTG) is the world’s largest and longest established HIV research network. The ACTG conducts groundbreaking studies to improve the treatment of HIV and its complications, reduce new infections and HIV-related illness, and advance new approaches to prevent, treat, and ultimately cure HIV in adults and children. ACTG investigators and research units in 12 countries serve as major resources for HIV/AIDS research, treatment, care, and training/education in their communities. ACTG studies have helped establish current paradigms for managing HIV disease, and have informed HIV treatment guidelines, resulting in dramatic decreases in HIV-related mortality worldwide.

 

 

# # #

 

 




Filters close

Showing results

110 of 3718
Released: 20-Oct-2020 5:40 PM EDT
Nearly a Quarter of New York City Transit Workers Report Having Had COVID-19
New York University

A survey of New York City’s bus and subway workers finds that 24 percent report having contracted COVID-19 and 90 percent fear getting sick at work. The pilot study, conducted by researchers at NYU School of Global Public Health, in coordination with the Transport Workers Union (TWU) Local 100, helps document the toll the pandemic has taken on the physical and mental health of essential workers.

Released: 20-Oct-2020 5:10 PM EDT
Viral post claiming Dr. Anthony Fauci was indicted is entirely false
Newswise

A Facebook post from May that is newly gaining traction says that Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and the leading voice of experts in the coronavirus pandemic, has been indicted for treason. This claim is entirely false. Despite President Donald Trump calling him a "disaster," Fauci has not been indicted. There is no news coverage to support this claim, nor any original, credible documents or sources to corroborate it.

Released: 20-Oct-2020 4:10 PM EDT
Safety Considerations for Visiting Primary Care Doctors
Rutgers University-New Brunswick

The COVID-19 pandemic has left many people with chronic health conditions relying on telemedicine rather than seeing their doctor in person when necessary or putting off important visits entirely because they fear being infected. Ann M. Nguyen, an assistant research professor at Rutgers Center for State Health Policy at the Institute for Health, Health Care Policy and Aging Research, who recently published a paper on safety measures at physician offices, discusses what people should know about visiting their doctor and why putting off appointments that need to be done in person could lead to other health problems.

Released: 20-Oct-2020 3:50 PM EDT
New Jersey, Nation Surpass Halfway Employment Recovery Mark
Rutgers University-New Brunswick

New Jersey gained back half of the jobs lost due to the coronavirus pandemic but a wide disparity remains between higher-income professionals working at home and lower-wage support workers still bearing the brunt of the economic downturn that has gripped the nation, according to a new Rutgers report.

Newswise: 246364_web.jpg
Released: 20-Oct-2020 3:25 PM EDT
Effective ventilation may be a key factor in preventing the spread of COVID-19
ESTONIAN RESEARCH COUNCIL

During the first wave of COVID-19, which paralyzed the world in spring, it was initially thought that effective hand washing and 2-metre social distancing would help prevent the highly contagious virus.

Released: 20-Oct-2020 3:10 PM EDT
Researchers discovered the second 'key' used by the SARS-CoV-2 virus to enter into huma
University of Helsinki

To efficiently infect human cells, SARS-CoV-2, the virus that causes COVID-19, is able to use a receptor called Neuropilin-1, which is very abundant in many human tissues including the respiratory tract, blood vessels and neurons. The breakthrough discovery was made by a German-Finnish team of researchers led by neuroscientists Mika Simons ,Technical University of Munich, Germany and virologist Giuseppe Balistreri, University of Helsinki, Finland.

Released: 20-Oct-2020 2:50 PM EDT
Population currently sees coronavirus as the greatest health risk
BFR Federal Institute For Risk Assessment

Next on the list of concerns, though notably less frequently mentioned, are unhealthy or wrong diet as well as climate and environmental pollution - these were the most frequently mentioned concerns in February's survey. "The coronavirus pandemic dominates public perception", says BfR President Professor Dr. Dr. Andreas Hensel.

Released: 20-Oct-2020 2:45 PM EDT
Trump Mocked Biden for Saying He'll ‘Listen to the Scientists’
Newswise

U.S. President Donald Trump emphasized his stark contrast to his opponent Joe Biden in dealing with the COVID-19 pandemic when he mocked Biden for saying he'll "listen to scientists."

Released: 20-Oct-2020 2:35 PM EDT
Most psoriasis patients taking immunosuppressants survive COVID-19
National Institute for Health Research

Patients with psoriasis who are taking drugs that affect their immune system have high rates of survival from COVID-19. According to the first findings from a global registry of psoriasis and COVID-19 patients, led by Guy's and St Thomas' clinicians, over 90% survive.

Newswise: Halloween Safety in the Coronavirus Era
Released: 20-Oct-2020 2:20 PM EDT
Halloween Safety in the Coronavirus Era
Cedars-Sinai

Halloween isn't going to be the same this year, but families can still have fun while reducing their risk of exposure to the virus that causes COVID-19 (coronavirus), says Priya Soni, MD, a Cedars-Sinai pediatric infectious disease specialist.


Showing results

110 of 3718

close
3.23916