WHO SOLIDARITY study published in NEJM
9 December 2020. Related: COVID-19: investigational drugs, COVID-19.
Simon Collins, HIV i-Base
On 2 December 2020, the controversial results from the international, randomised, open label WHO SOLIDARITY study were published in NEJM. [1]
Earlier results were published ahead of peer review last month. [2]
This large study randomised more than 11,500 adults from over 400 sites in 30 countries to remdesivir (n=2750), hydroxychloroquine (HCQ, n=954), lopinavir (LPV/r) without interferon (n=1411), interferon (IFN, n=2063, including 651 to interferon plus lopinavir) or a control arm with no study drugs (n=4088).
None of these drugs significantly reduced mortality (including in any subgroup) or needing ventilation or duration of hospitalisation (including remdesivir).
Rate ratios for death by day 28 were, 0.95 (95%CI: 0.81 to 1.11);,1.19 (95% CI: 0.89 to 1.59); 1.00 (95% CI: 0.79 to 1.25); and 1.16 (95% CI: 0.96 to 1.39), for remdesivir, HCQ, LPV/r, and IFN respectively.
In a related editorial, SOLIDARITY is recognised as a significant achievement in rapidly enrolling so many participants from very diverse health settings and that the results “sends the clear message that these drugs as currently used should no longer be considered viable treatment options for Covid-19”. [3]
It separates the more controversial results on remdesivir as “more nuanced” due to its role in reducing hospital duration (the basis for current FDA and EU approval). However, it also suggests that further research is needed on timing of remdesivir, use in specific populations, and in combination with other drugs before concluding: “It will not be simple to achieve clarity on when and how – or even whether –to use remdesivir”.
References
- WHO Solidarity Trial Consortium. Repurposed antiviral drugs for COVID-19 — interim WHO Solidarity trial results. NEJM. DOI: 10.1056/NEJMoa2023184. (2 December 2020).
https://www.nejm.org/doi/full/10.1056/NEJMoa2023184 - No survival benefit from remdesivir, hydroxychloroquine, lopinavir/r or interferon-β1a in moderate and severe COVID-19: interim results from the WHO SOLIDARITY study. HTB (11 November 2020).
https://i-base.info/htb/39223 - Harrington DP et al. A large, simple trial leading to complex questions. NEJM. DOI: 10.1056/NEJMe2034294. (2 December 2020).
https://www.nejm.org/doi/full/10.1056/NEJMe2034294
This report was first posted on 3 December 2020.