First results from a controlled trial in COVID-19 patients supports the case for larger trials

The first results from a randomised controlled trial of a treatment for COVID-19 provide support for larger trials of the drug.

Lopinavir-ritonavir is an antiviral drug used in HIV that has previously shown promise in laboratory studies in SARS and Middle East Respiratory Syndrome coronaviruses.  

Since early January colleagues in China, supported by researchers at the ISARIC Support Centre at the University of Oxford, have run a randomised controlled trial of lopinavir-ritonavir in patients hospitalised with COVID-19.

The first patient was enrolled in the LOTUS trial on the 19^th January, just 20 days after WHO announced the outbreak in Wuhan. The results of the trial have been published today in the New England Journal of Medicine

Trial results

One hundred patients were randomised to standard care and 99 patients were randomised to standard care plus lopinavir-ritonavir for 14 days.

Allocation to lopinavir-ritonavir was not associated with a statistically significant difference in time to clinical improvement, and mortality 28 days after randomisation was similar in both groups (19% in the lopinavir-ritonavir patients versus 25% in the standard of care patients).

However, the trial found that patients treated with lopinavir-ritonavir spent less time in hospital (12 vs. 14 days) and in intensive care (6 vs. 11 days).  

Next steps

Although this study did not find a benefit of treatment, the trial enrolled severely ill patients and was not big enough to detect modest benefits Much larger studies in patients with COVID-19 are warranted to confirm or exclude if lopinavir-ritonavir treatment can help.

Oxford, United Kingdom  – 19 March

Full article here:

https://www.nejm.org/doi/full/10.1056/NEJMoa2001282?query=featured_home#article_references