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COVID-19 is an illness caused by the virus SARS-CoV-2 virus. Currently, there is no approved therapeutic or vaccine to prevent or treat COVID-19. As you know, this virus has spread around the globe from Wuhan, Hubei Province, China, since it was first reported in December 2019.
As of May 14, 2020, WHO (the World Health Organization) has reported 4,218,212 cases and 290,242 COVID-19 related deaths globally.
On March 26, 2020, the United States became began reporting more COVID-19 cases than any other country. As of May 13, 2020, the CDC (Centers for Disease Control and Prevention) has reported 1,364,061 COVID-19 cases and 82,246 related deaths.
“There is an urgent need to quickly evaluate treatments for COVID-19, which, in recent months, has emerged as a global pandemic,” ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles, said. “We need well-designed trials to evaluate whether drugs that have been used and studied over the years to treat other illnesses are effective on COVID-19. ACTG has a history of implementing a variety of clinical trials over the last 33 years. This positions us to execute this clinical trial quickly, and determine whether hydroxychloroquine and azithromycin could be an effective treatment for COVID-19.”
The AIDS Clinical Trials Group is conducting the placebo-controlled, double-blind, randomized phase 2b clinical trial at 31 of its U.S.-based locations. The study will enroll around 2,000 adults who have contracted COVID-19. You can find the list of locations here.
The study is sponsored by NIAID (the National Institute of Allergy and Infectious Diseases), which is part of the National Institutes of Health. NIAID also funds the ACTG.
Randomized study participants will orally receive one of two plans. The first group will receive a 400 mg dose of hydroxychloroquine twice a day on the first day, followed by 200 mg twice a day for six days. Additionally, on the first day, this group will receive 500 mg of azithromycin, followed by 250 mg of azithromycin every day for four days. The second group will receive placebos.
To qualify for the study, potential participants must test positive for SARS-CoV-2 in an outpatient setting. In addition, participants must experience at least one of the following symptoms: cough, fever, or shortness of breath. Eligible participants include those living with HIV, as well as women who are pregnant or currently breastfeeding.
The drug hydroxychloroquine is currently approved for preventing and treating malaria, as well as for treating autoimmune conditions, including lupus and rheumatoid arthritis.
Azithromycin is an antibiotic currently approved to treat bacterial infections, including community-acquired pneumonia, pharyngitis, sinusitis, urethritis/cervicitis, and acute exacerbation of COPD.
There has been evidence that this drug combination can decrease the viral load in those with COVID-19. A big, well-controlled clinical trial will determine its true efficacy. The ACTG, with its ability to use its global sites and staff to quickly conduct trials, is ideally positioned to conduct a major clinical trial among patients with COVID-19 during this pandemic.
The study, ACTG 5395, is led by protocol chair Davey Smith, M.D. of the University of California, San Diego. Also leading the study are David Wohl, M.D. of the University of North Carolina, Eric S. Daar, M.D. of the University of California, Los Angeles, and Kara W. Chew M.D., M.S.
“Since the COVID-19 pandemic has been especially devastating to people who have underlying health issues and are older, our goal is to have at least half of the study participants be in these high-risk groups,” said Dr. Smith. “With a meaningful representation of people who are immuno-compromised, 60 years and older and people with chronic lung, liver and kidney disease, hypertension, severe obesity, or diabetes, we hope to gain valuable insights that will directly impact caring for people with COVID-19.”
Founded in 1987, the AIDS Clinical Trials Group is the largest and best established HIV research network in the world. The ACTG conducts innovative studies to provide better treatment of HIV and its complications. Likewise, the ACTG also conducts studies aimed at reducing new infections and HIV-related illnesses. Finally, the ACTG is dedicated to advancing new ways to prevent, treat, and finally cure HIV in both adults and children.
We have investigators and research groups in 12 countries and ACTG serves as a major resource for HIV/AIDS research, treatment, and care. ACTG also provides training and education in their local communities. Our studies have helped to establish the current treatments for managing HIV, as well as informing HIV treatment guidelines. Due to our decades of work in this field, there has been a dramatic decrease in HIV-related mortality globally.