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Fighting COVID-19: NIH In Bethesda Begins Clinical Trial Of Hydroxychloroquine And Azithromycin Combination

MBS Staff

The National Institutes of Health (NIH) announced that a clinical trial has begun using a combination of the malaria drug hydroxychloroquine along with the antibiotic azithromycin. They enrolled the first participant yesterday in San Diego, California.

Hydroxychloroquine has consistently made headline news this year as a potential treatment for COVID-19 in large part due to it being touted by President Trump as a “game changer.” The nation's medical research agency is now looking into the matter and will see for itself if the drug actually makes an impact on the coronavirus.

“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 National Institute of Allergy and Infectious Diseases (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.”

The Phase 2b drug trial is going to enroll a total of 2,000 patients from all over the United States. The NIAID (a component of NIH) will sponsor the trial led by the NIAID-funded AIDS Clinical Trials Group (ACTG). Israel-based Teva Pharmaceuticals is donating medications for the study.

NIH said the World Health Organization (WHO) reported 4.17 million cases and 287,399 deaths from COVID-19 worldwide. In the United States the Centers for Disease Control and Prevention (CDC) reported 1.36 million COVID-19 cases and 82,246 deaths. Both reports are as of May 13.

Several Montgomery County biotechs have received national attention for their involvement in fighting COVID-19. One of the companies constantly in the media is Gaithersburg-based Novavax (NASDAQ: NVAX) that is fast-tracking a vaccine for COVID-19. The company made a recent announcement that it received an additional $384 million in funding towards that goal. Its stock price has skyrocketed in a matter months with its market value jumping from a little over $100 million in November 2019 to $2.5 billion in early May. Emergent BioSolutions (NYSE: EBS) is also getting coverage as a large vaccine manufacturer supporting not only Novavax but big pharma as well. Also based in Gaithersburg, the company recently announced it would receive $135 million from Johnson & Johnson (NYSE: JNJ) to manufacture their COVID-19 candidate vaccine in Baltimore.