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NIH starts Covid-19 trial of drug touted by Trump

Study ‘urgently needed’ as many hospitals are already using hydroxychloroquine on patients, lead researcher says

The National Institutes of Health has enrolled the first patients onto a multi-site US clinical trial of the drug hydroxychloroquine as a potential treatment for Covid-19, after the drug was repeatedly talked up by president Donald Trump on little scientific basis.

The Orchid study will use the NIH’s lung injury clinical trial network to recruit Covid-19 patients from across the US, the NIH said on 9 April, with the first patients already recruited at Vanderbilt University Medical Centre in Tennessee.

Many hospitals are already using the anti-malarial drug as a treatment for Covid-19, a viral respiratory infection, despite there being “extremely limited clinical data supporting its effectiveness”, said Wesley Self, the lead investigator for the trial.

Self, who is based at VUMC, said this meant that data on the efficacy and dangers of using the drug to treat Covid-19 were “urgently needed to inform clinical practice”.

The trial follows the controversial decision by the Food and Drug Administration chief scientist Denise Hinton to grant emergency approval of the use of forms of the drug to treat Covid-19, in response to a request from Rick Bright, director of the Biomedical Advanced Research and Development Authority.

One former head of the FDA, Margaret Hamburg, told Science magazine that approving emergency use of chloroquine phosphate and hydroxychloroquine sulfate to treat Covid-19 could hamper data collection on its efficacy.

The approval, combined with the promotion of hydroxychloroquine by Trump, could mean patients will be less likely to enrol on a trial and risk getting a placebo, Covid-19 researcher David Boulware told Science.

The FDA did not respond to a request for comment.

The Orchid study hopes to recruit 500 hospitalised Covid-19 patients, which would dwarf an earlier French study of 36 patients that has been influential in the drug’s promotion by the White House.

In a press conference on 5 April, Trump referred to the use of hydroxychloroquine as a promising treatment for Covid. “What do you have to lose?” he said, referring to severely ill Covid-19 patients. “I really think they should take it.” He described the use of the drug in combination with an antibiotic as “one of the biggest game changers in the history of medicine”.

The International Society of Antimicrobial Chemotherapy and the academic publisher Elsevier have both distanced themselves from the write-up of the French trial, which was published in a journal they co-own, the International Journal of Antimicrobial Agents.

The study “does not meet the society’s expected standard”, ISAC said in a statement, specifically raising concerns about patient safety due to the criteria used to select participants.

In a separate statement, the society and publisher defended the peer review process at the IJAA, after it emerged that one of the paper’s authors, Jean-Marc Rolain, is also the editor in chief of the journal.

“The journal’s standard peer review process was followed in the publication of this paper,” they said in a statement, adding that Rolain was not involved in the peer review process of his work but noting that concerns had also been raised “regarding the content, the ethical approval of the trial”.

Elsevier is carrying out post-publication peer review of the study and its authors have been contacted and asked to respond to the concerns raised, it said. 

The Orchid trial is expected to finish collecting data on the efficacy of hydroxychloroquine by the end of April, with data collection on the drug’s longer-term effects due to carry on until July 2021.

Forms of the drug are one of four treatments being tested as part of a global WHO megatrial into potential treatments for Covid-19 called Solidarity.