National Health Institutes to evaluate a combination of antibiotic drug and Teva's malaria drug

The National Institutes of Health said it began a study to evaluate the combination of antibiotic azithromycin and malaria drug hydroxychloroquine, which was previously touted by U.S. President Donald Trump as a "game changer" for the treatment of COVID-19.
The study, for which Teva Pharmaceutical Industries Ltd will be donating medicines, will assess whether the combination can prevent hospitalization and death from COVID-19, the coronavirus respiratory disease.
 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.

The Phase 2b trial will enroll approximately 2,000 adults at participating ACTG sites (link is external) across the United States. Study participants must have confirmed infection with SARS-CoV-2, the virus that causes COVID-19, 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 placebos. People living with HIV and pregnant and breastfeeding women are also eligible to participate in the study. The first participant enrolled today in San Diego, California.
“We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment, ”said NIAID Director Anthony S. Fauci, M.D. "Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes."
As of May 13, the World Health Organization (WHO) (link is external) has reported 4.17 million cases of and 287,399 deaths from COVID-19 worldwide. In the United States, 1.36 million confirmed COVID-19 cases and 82,246 deaths have been reported as of May 13, according to the Centers for Disease Control and Prevention (CDC) (link is external).
Currently, there are no specific therapeutics approved by the U.S. Food and Drug Administration to treat people with COVID-19. Hydroxychloroquine is FDA approved to prevent and treat malaria, as well as to treat the autoimmune diseases rheumatoid arthritis and lupus. Some preliminary reports have suggested that hydroxychloroquine, alone or in combination with the FDA-approved antibiotic azithromycin, may benefit people with COVID-19. Numerous clinical trials are planned or underway, including a recently launched study supported by NIH's National Heart, Lung and Blood Institute evaluating the safety and effectiveness of hydroxychloroquine for treatment of adults hospitalized with COVID-19. On March 28, the FDA issued an Emergency Use Authorization (link is external) (EUA) to allow hydroxychloroquine and medical-grade chloroquine to be distributed from the Strategic National Stockpile and prescribed by doctors to hospitalized adolescents and adults with COVID-19, as appropriate , when a clinical trial is not available or feasible.
Participants in the ACTG study, called A5395, will receive oral medications to take 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 will also 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. Whenever possible, participants will come to the clinical research site for an in-person visit on day 20. Additional follow-ups will be conducted by telephone three and six months after treatment begins.
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