White House working on platform to track patient outcomes for off-label COVID-19 drugs: NYT

White House
The White House is preparing a platform to promote off-label use of drugs to treat COVID-19, NYT reports. (Photo by AndrewSoundarajan/iStock/Getty Images Plus/Getty Images)

As President Donald Trump continues to tout hydroxychloroquine as a potential COVID-19 treatment—despite wait-and-see advice from health officials—the White House is preparing to roll out a platform to promote the drugs and track patients’ progress, The New York Times reports.

The drug, which has been used for decades to treat malaria, lupus and arthritis, is available for cheap. Several drugmakers have pledged donations and scaled up manufacturing to help meet potential demand. Meanwhile, reports of shortages have popped up as fervor around the medicine swells, and one analyst has his own hesitations about early "positive" clinical data from China.

The White House engaged tech giant Oracle to help with the project, which aims to log information about off-label usage of chloroquine and hydroxychloroquine—and perhaps other medicines, NYT reports. Some experts worry the program would essentially represent a massive uncontrolled clinical trial. 

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Meanwhile, New York has started running a trial combining hydroxychloroquine with the antibiotic azithromycin, following approval from the FDA, according to reports. With more than 25,000 cases of COVID-19, the state is by far the hardest hit in the U.S.

Enthusiasm around hydroxychloroquine stems partly from early data from a French study (PDF) conducted by professor Didier Raoult and his team. In that study, 70% of patients given hydroxychloroquine tested negative for the virus after six days. In the control arm, only two out of 16 patients were negative after six days. Some of the hydroxychloroquine patients also received the antibiotic azithromycin; all six of them tested negative.

Weighing the findings, two experts told investigative journalist Mary Beth Pfeiffer the results were enough for them to recommend the treatment regimen of hydroxychloroquine and azithromycin for patients hospitalized with COVID-19, considering the graveness of the pandemic and lack of available treatments. 

RELATED: Amid frenzy over potential COVID-19 drug, patients see shortages and states fight reckless scripts 

Some experts worry about hyping the meds as a “game changer,” as the president has, without adequate data. National Institute of Allergy and Infectious Diseases Director Anthony Fauci has said that any data to date are “anecdotal.” He and other federal health officials met Tuesday to discuss their problems with the Oracle plan, NYT reports. 

As attention to the medicines ratchets up, some patients who have taken hydroxychloroquine for years have reported shortages. One wrote to FiercePharma that her pharmacist instructed her to call around the state and a neighboring state for her medication.

Hydroxychloroquine and chloroquine are just a couple of existing medicines being touted as a potential treatments for COVID-19 as scientists work on advancing new therapies. But in recent days, hydroxychloroquine, AbbVie’s HIV med Kaletra and influenza med Arbidol each disappointed in preliminary studies. 

RELATED: Top COVID-19 aspirants chloroquine, AbbVie’s Kaletra and a flu drug disappoint in clinical tests 

The hydroxychloroquine study, conducted in China, had earlier been characterized as a “positive” result, but Evercore ISI analyst Umer Raffat begged to differ after looking into the data for himself. Hydroxychloroquine failed to beat placebo at virological clearance rate and temperature normalization at day seven, he pointed out. 

Follow these links to learn more about other drug and vaccine projects underway. 

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