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 2822
Newswise: coronavirus-image1-300x300.jpg
Released: 6-Aug-2020 11:20 AM EDT
WashU Expert: Pandemic lessons from 2-1-1
Washington University in St. Louis

There have been more than 3.5 million requests for assistance to 2-1-1 help lines around the United States since the coronavirus pandemic hit this spring. The impact was immediate and dramatic, said a Brown School researcher who tracks calls to 2-1-1 help lines across the U.S.During COVID-19, the volume of requests to 2-1-1s has increased exponentially, said Matthew Kreuter, the Kahn Family Professor of Public Health at Washington University in St.

Newswise: Cancer vs. COVID: When a pandemic upended cancer care
5-Aug-2020 12:40 PM EDT
Cancer vs. COVID: When a pandemic upended cancer care
Michigan Medicine - University of Michigan

A team of researchers interviewed physicians and patients at the beginning of the COVID-19 pandemic to identify eight scenarios impacting cancer care. Using communication strategies, they created examples of language to help oncologists respond to patients empathetically.

Newswise:Video Embedded delay-in-breast-cancer-operations-due-to-covid-19-pandemic-appears-to-be-non-life-threatening-for-women-with-early-stage-disease
VIDEO
5-Aug-2020 4:25 PM EDT
Delay in breast cancer operations due to COVID-19 pandemic appears to be non-life-threatening for women with early-stage disease
American College of Surgeons (ACS)

A new breast cancer study brings reassuring findings for women with early-stage breast cancer who were forced to delay their cancer operations because of the Coronavirus Disease 2019 (COVID-19) pandemic.

Released: 6-Aug-2020 9:00 AM EDT
Blood Test May Point to Patients at Higher Risk for COVID-19 Deterioration, Death
George Washington University

George Washington University researchers found five biomarkers associated with higher odds of clinical deterioration and death in COVID-19 patients. Published in Future Medicine, these findings will help physicians better predict outcomes for COVID-19 patients in the U.S.

Released: 6-Aug-2020 8:10 AM EDT
Recovery After Severe COVID Infection Poses Unique Challenges
Michigan Medicine - University of Michigan

As more patients recovered from COVID-19 are discharged from stressed ICUs, they face multiple problems brought on by the pandemic.

Newswise: Two-Thirds of Adults Support Vaccination, National Survey Says
Released: 6-Aug-2020 8:05 AM EDT
Two-Thirds of Adults Support Vaccination, National Survey Says
Rutgers University-New Brunswick

When a COVID-19 vaccine becomes available, 66 percent of adults are likely to get vaccinated, and have their children vaccinated as well, according to a new nationwide survey led by researchers from Rutgers University–New Brunswick, Northeastern, Harvard, and Northwestern universities.

Released: 5-Aug-2020 10:05 PM EDT
UCLA Fielding School of Public Health team leading California state study of air pollution and COVID-19
UCLA Fielding School of Public Health

UCLA Fielding School of Public Health team leading California state study of air pollution and COVID-19. A research team led by UCLA Fielding School of Public Health faculty has been awarded a contract to study connections between air pollution and the COVID-19 pandemic, officials said.

Newswise:Video Embedded uab-department-of-pathology-develops-strategy-to-support-guidesafe-entry-testing-process-more-than-200-000-samples
VIDEO
Released: 5-Aug-2020 4:10 PM EDT
UAB Department of Pathology develops strategy to support GuideSafe™ Entry Testing, process more than 200,000 samples
University of Alabama at Birmingham

This strategy will allow for ramping up testing capacity tenfold for the next 20-plus days leading up to the start of school.


Showing results

110 of 2822

close
3.77938