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New data backs remdesivir for COVID-19, but rings hydroxychloroquine alarm bell

Remdesivir could speed recovery of patients with COVID-19, but hydroxychloroquine may not be safe


Gilead Sciences’ remdesivir has results suggesting it can speed the recovery of people with COVID-19, but hydroxychloroquine may not be safe and could make people less likely to get better.

Those are the divergent conclusions of new data reported in the last few days, as countries across Europe start to relax coronavirus lockdowns and contemplate measures to start an economic recovery.

The results with remdesivir are an update from the 1,063-patient ACCT-1 trial that catapulted remdesivir to the forefront of drug candidates to treat COVID-19, and underpinned emergency use authorisation in the US.

Reported in the New England Journal of Medicine, the new data reinforces the message that the drug is safe and does seem to reduce the time people need to stay in hospital, but in a new twist suggests that most of its benefit is in people who are less sick.

Those with the most severe symptoms who required mechanical ventilation as part of their treatment – who have the highest mortality rate – didn’t appear to benefit from the drug.

Overall, the updated results reveal that patients who received remdesivir recovered in a median of 11 days, compared to 15 days for those who received placebo.

The death rate in the remdesivir group was 7.1%, compared to 11.9% for placebo group – a non-significant difference that does improve a little on the earlier readout from the trial.

With remdesivir still in short supply, the finding suggests that initially at least it should be reserved for use in patients who aren’t critically ill with COVID-19, although the researchers note that the data isn’t locked for all patients yet and a further update will be needed “to fully understand the efficacy of remdesivir in this trial”.

WHO suspends hydroxychloroquine study arm

Meanwhile, the World Health Organization (WHO) has decided to suspend dosing of hydroxychloroquine in its SOLIDARITY drug trial after finding an increased risk of death in patients who were given the drug – which President Donald Trump famously says he has been taking prophylactically to ward off coronavirus infection.

The decision to halt treatment hydroxychloroquine and related drug chloroquine stems from a registry analysis published last week in medical journal The Lancet, looking at records of almost 15,000 patients, which found an elevated risk of ventricular arrhythmias and “lower in-hospital survival” when used in COVID-19 patients.

The WHO has launched a review of the data it has in hand from the chloroquine and hydroxychloroquine arms in SOLIDARITY, but will continue dosing patients in the other arms that are testing remdesivir, AbbVie's HIV drug Kaletra (lopinavir/ritonavir) and interferon beta-1a.

Not everyone agrees with the WHO’s cautionary stance on hydroxychloroquine’s safety, however. Professor Peter Horby, who is leading the University of Oxford’s large-scale RECOVERY trial of coronavirus drugs, told the BBC’s Today programme this morning that his team hasn’t seen that safety signal.

RECOVERY – the largest study of COVID-19 worldwide with more than 10,000 patients enrolled – should be a better judge of hydroxychloroquine as it comes from a randomised, prospective study, rather than looking back at hospital records, he said.

The RECOVERY team looked at their own data in response to the WHO announcement but didn’t find an increased risk of death, so are pressing ahead with the hydroxychloroquine arm of their study.

The study has been testing hydroxychloroquine, antibiotic azithromycin, steroid dexamethasone, Kaletra and Roche’s anti-inflammatory RoActemra (tocilizumab) for activity against COVID-19.

Today, the Oxford team added another treatment arm to the study that will look at the use of convalescent plasma that has been collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus.

Article by
Phil Taylor

26th May 2020

From: Research, Regulatory, Healthcare



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