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Randomized Controlled Trial
. 2022 Aug 4;17(8):e0269065.
doi: 10.1371/journal.pone.0269065. eCollection 2022.

Efficacy and safety of anakinra in adults presenting deteriorating respiratory symptoms from COVID-19: A randomized controlled trial

Alexandra Audemard-Verger  1   2 , Amélie Le Gouge  3 , Vincent Pestre  4 , Johan Courjon  5 , Vincent Langlois  6 , Marc-Olivier Vareil  7 , Mathilde Devaux  8 , Boris Bienvenu  9 , Vincent Leroy  10 , Radjiv Goulabchand  11 , Léa Colombain  12 , Adrien Bigot  1 , Thomas Guimard  13 , Youcef Douadi  14 , Geoffrey Urbanski  15 , Jean François Faucher  16 , Laurence Maulin  17 , Bertrand Lioger  18 , Jean-Philippe Talarmin  19 , Matthieu Groh  20 , Joseph Emmerich  21 , Sophie Deriaz  1 , Nicole Ferreira-Maldent  1 , Ann-Rose Cook  1 , Céline Lengellé  22 , Hélène Bourgoin  23 , Arsène Mekinian  24 , Achille Aouba  25 , François Maillot  1   2 , Agnès Caille  2   3
Affiliations
Randomized Controlled Trial

Efficacy and safety of anakinra in adults presenting deteriorating respiratory symptoms from COVID-19: A randomized controlled trial

Alexandra Audemard-Verger et al. PLoS One. .

Abstract

Objective: We aimed to investigate whether anakinra, an interleukin-1receptor inhibitor, could improve outcome in moderate COVID-19 patients.

Methods: In this controlled, open-label trial, we enrolled adults with COVID-19 requiring oxygen. We randomly assigned patients to receive intravenous anakinra plus optimized standard of care (oSOC) vs. oSOC alone. The primary outcome was treatment success at day 14 defined as patient alive and not requiring mechanical ventilation or extracorporeal membrane oxygenation.

Results: Between 27th April and 6th October 2020, we enrolled 71 patients (240 patients planned to been enrolled): 37 were assigned to the anakinra group and 34 to oSOC group. The study ended prematurely by recommendation of the data and safety monitoring board due to safety concerns. On day 14, the proportion of treatment success was significantly lower in the anakinra group 70% (n = 26) vs. 91% (n = 31) in the oSOC group: risk difference-21 percentage points (95% CI, -39 to -2), odds ratio 0.23 (95% CI, 0.06 to 0.91), p = 0.027. After a 28-day follow-up, 9 patients in the anakinra group and 3 in the oSOC group had died. Overall survival at day 28 was 75% (95% CI, 62% to 91%) in the anakinra group versus 91% (95% CI, 82% to 100%) (p = 0.06) in the oSOC group. Serious adverse events occurred in 19 (51%) patients in the anakinra group and 18 (53%) in the oSOC group (p = 0·89).

Conclusion: This trial did not show efficacy of anakinra in patients with COVID-19. Furthermore, contrary to our hypothesis, we found that anakinra was inferior to oSOC in patients with moderate COVID-19 pneumonia.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow chart.
Fig 2
Fig 2. Secondary outcomes for analyzed patients over 28 days’ follow-up.
A, Overall survival; B, Cumulative incidence of ICU admission; C, Cumulative incidence of need for ventilatory support; D, Cumulative incidence of oxygen independency; and E, Cumulative incidence of hospital discharge. ICU, intensive care unit; oSOC, optimized standard of care.
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