A WHO expert panel has strongly recommended against the use of hydroxychloroquine as prophylaxis against COVID-19 and has also advised against continuing any clinical trials of the drug for prevention.
The WHO has previously recommended against use of hydroxychloroquine as treatment for COVID-19 but now in the first version of a living guideline for drugs to prevent COVID-19, a WHO Guideline Development Group (GDG) panel of international experts has also made “a strong recommendation against the use of hydroxychloroquine for individuals who do not have COVID-19 (high certainty).”
Published in the BMJ, the guidance is based on high certainty evidence from six randomised controlled trials involving over 6,000 participants with and without known exposure to a person with COVID-19 infection, which showed that hydroxychloroquine had no meaningful effect on death and admission to hospital. Moderate certainty evidence showed that hydroxychloroquine had no meaningful effect on laboratory confirmed COVID-19 infection and it probably increased the risk of adverse effects.
The panel noted that hydroxychloroquine had shown an antiviral effect against many viruses in vitro, including SARS-CoV-2, but no clinically useful antiviral effect had been shown for any viral infection.
As such, the panel judged that almost all people would not consider the drug worthwhile.
It also noted that use of hydroxychloroquine for prophylaxis would divert supplies away from its appropriate use in conditions such as SLE.
In addition the panel “considers that this drug is no longer a research priority and that resources should be used to evaluate other more promising drugs to prevent COVID-19.”
“More than 80 trials planning to enrol at least 100 000 participants are registered or ongoing. The high certainty evidence that has emerged regarding the lack of effect of hydroxychloroquine prophylaxis suggests that funders and researchers should reconsider the initiation or continuation of these trials,” it said.
The investigators in an Australian clinical trial of hydroxychloroquine for prophylaxis in healthcare workers told the limbic that their COVID-SHIELD trial was no longer recruiting patients.
“We are in the process of analysing the data and are expecting results of this study between May and July 2021,” said a spokesperson for the Walter and Eliza Hall Institute (WEHI) in Melbourne.
“We are harmonising our data with similar trials internationally, to allow data sharing and complementary analyses of results,” they said.
The COVID-SHIELD trial had originally aimed to recruit 650 participants but stopped recruiting after 250, according to the Australia and NZ Clinical Trail Registry.