The National Institute of Allergy and Infectious Diseases (NIAID), part of the National institutes of Health (NIH), announced its sponsoring of a clinical trial to evaluate the malaria drug hydroxychloroquine in combination with azithromycin to determine if the treatment can prevent hospitalization and death from SARS-CoV-2, the virus behind the COVID-19 pandemic. Teva Pharmaceuticals has donated the medications to support the study.
A Phase II clinical trial, the sponsor seeks to enroll 2,000 adults at participating ACTG sites across America. The AIDS Clinical Trials Group (ACTG) is the worlds largest and longest running HIV clinical trials network. Study participants must have confirmed infection with SARS-CoV-2 and be experiencing fever, cough and /or shortness of breath. The investigators anticipate that many of those enrolled will be 60 years of age or older or have a comorbidity associated with developing serious complications from COVID-19, such as cardiovascular disease or diabetes. Participants will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebo. People living with HIV and pregnant and breastfeeding women also are eligible to participate in the study. The first participant enrolled today in San Diego, California.
Participants in the ACTG study, called A5395, will receive oral medications to take at home. Those randomly assigned to the experimental treatment group will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for an additional six days. They also will take 500 mg of azithromycin on the first day and 250 mg daily for an additional four days. The control group will receive equivalent numbers of placebo pills. Neither the participants nor the study team will know who received experimental treatment or placebo until the end of the trial.
Participants will record their symptoms, adherence to treatment, and major events such as hospitalizations in a diary for 20 days. Study staff will follow up with participants by telephone during this period. When possible, participants will come to the clinical research site for an in-person visit at day 20. Additional follow-ups will be conducted by telephone three and six months after treatment starts.
The main objective of the study is to determine whether hydroxychloroquine and azithromycin can prevent hospitalization and death due to COVID-19. Additionally, investigators will evaluate the safety and tolerability of the experimental treatment for people with SARS-CoV-2 infection. While hydroxychloroquine and azithromycin are both considered safe in most people, they can cause side effects ranging from headache and nausea to, rarely, heart rhythm problems that can be life-threatening. Because of the risk of heart problems when hydroxychloroquine is used alone or combined with azithromycin, FDA cautions that use of hydroxychloroquine for COVID-19 should be limited to clinical trials or for treating certain hospitalized patients under EUA so clinicians can monitor patients for adverse effects.
Urgent Need for Treatments
Dr. Anthony Fauci, MD, NIAID Director, declared, “We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone existing testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment.” Dr. Fauci reported that the quest is now to understand whether hydroxychloroquine and azithromycin can offer benefit to COVID-19 patients based on “solid data from a large randomized, controlled clinical trial.”
Study Chair, Davey Smith, MD, University of California, San Diego