URMC to conduct trials of controversial drug

The University of Rochester Medical Center plans to launch a pair of randomized clinical trials this week to test the controversial antimalarial drug hydroxychloroquine’s effectiveness as an anti-COVID-19 agent. 

Conceding that the planned trial of the antimalarial drug comes “amid the recent swirl of contradictory reports,” URMC researchers describe the local effort as one that would provide “conclusive evidence that can guide future treatment of COVID-19 patients.” 

Though evidence of the drug’s effectiveness so far “has not been particularly encouraging,” no “gold standard” randomized trial of hydroxychloroquine has yet been undertaken to determine definitively whether the drug works to cure or inhibit COVID-19, says Michael Keefer M.D., URMC interim chief of infectious diseases and the trials’ principal investigator. 

Hydroxychloroquine burst into international prominence in March after being heavily touted by President Donald Trump as a “game changer” that would not only cure COVID-19 but would act as a preventive to keep the coronavirus at bay for uninfected individuals. 

The president’s enthusiasm was apparently sparked at least in part by the research of Didier Raoult, a French microbiologist who published a study claiming to have achieved a 100 percent COVID-19 cure rate by combining hydroxychloroquine with the antibiotic azithromycin.

In March, while the president enthusiastically urged Americans to take hydroxychloroquine as a COVID-19 cure-all, Anthony Fauci M.D., director of the National Institute of Allergy and Infectious Diseases, and a prominent member of Trump’s COVID-19 task force, downplayed studies claiming to prove hydroxychloroquine’s effectiveness as an antiviral. Such research offered only unproven anecdotal evidence; no treatment had yet been proven to be an effective COVID-19 foil, Fauci cautioned. 

NIAID is a sponsor of one of the two hydroxychloroquine trials URMC plans to join. The other is sponsored by the Swiss pharmaceuticals company Novartis, the maker of hydroxychloroquine. 

Since March, a trial of the antimalarial drug, which has been linked to fatal heart arrhythmia in some patients, was halted in Brazil over fears that the drug might be killing patients while providing at best scant help. 

Nevertheless, Brazilian President Jair Bolsonaro has echoed Trump’s enthusiasm for the drug. The announcement of the start of URMC’s and other U.S. hydroxychloroquine randomized trials comes two days after the United States and Brazil released a joint statement revealing that the United States is sending 2 million doses of hydroxychloroquine to Brazil. The drug is to be given to Brazilian doctors, nurses and health care workers and to treat Brazilian patients, the statement says.

“With President Donald J. Trump and President Jair Bolsonaro having spoken twice since March, the two countries are well-positioned to continue their work together to address the coronavirus pandemic, in addition to other matters of strategic importance,” the joint statement says.

Also pulling back on hydroxychloroquine trials is the World Health Organization, which late last month suspended trials of the drug. WHO officials cited a study published by the British medical journal the Lancet that found hydroxychloroquine to be potentially fatal yet ineffective against COVID-19.  

Expressing doubts over data sets used by researchers who conducted the Lancet study, some scientists have questioned the study’s methods. 

While questions concerning hydroxychloroquine’s effectiveness as a COVID-19 cure or preventive have mounted, Trump last week continued to stoke controversy surrounding the drug by announcing that he was completing a two-week course of hydroxychloroquine doses to ward off COVID-19. Asked by reporters what evidence he had that the drug worked, Trump cited positive calls from unnamed individuals.

Hydroxychloroquine is approved by the Food and Drug Administration as an antimalarial and has been long used to treat that illness. It also has been found to quell symptoms suffered by patients afflicted with lupus, a chronic autoimmune disease that mostly affects women and causes intermittent flareups of variable symptoms that can include painful rashes and swollen joints. 

While the antimalarial drug is not FDA-approved as a COVID-19 treatment, the FDA has released quantities of hydroxychloroquine from the government’s strategic pharmaceuticals stockpile to be given to nursing home and hospital COVID-19 patients who want to take it.  

URMC is one of some 25 U.S. sites conducting such trials. (Anyone wishing to volunteer or learn more can call 585-273-3990.)

Says Keefer: “We really don’t know yet if hydroxychloroquine can help people recover from COVID-19, so it’s really important that we study it in a careful controlled way.” 

Will Astor is Rochester Beacon senior writer. All coronavirus articles are collected here.