The prognosis of severe COVID-19 pneumonia remains poor, despite therapeutic advances.
Methods
The Corimmuno19-BEVA randomized controlled trial evaluated efficacy and safety of BEV in severe COVID-19 pneumonia (OMS 6 to 8) requiring high-flow nasal oxygen (HFNO), noninvasive (NIV) or invasive mechanical ventilation (IMV). Exclusion criteria were active pulmonary thromboembolism (PE), bacterial pneumonia and CI to BEV. Primary endpoint was time-to-drop to OMS category ?5, during the 28 days after randomization, analyzed in intent-to-treat basis, using Aalen-Johansen method. Safety analysis was conducted up to D120.
Findings
The study started on April 2021 and stopped on March 2022, due to low inclusion rate. 96 pts (62.0 yr [54.5-70.0], 69% men) were assigned to receive SoC (n=48) alone or combined with BEV (7.5 mg/kg) (n=48) at randomization. At D1 pts received HFNO (n=83), NIV (n=4) or IMV (n=7). SoC were steroids (n=92), anticoagulation (n=94) and tocilizumab (n=32). At D28, 36 pts (SoC) and 37 pts (BEV) dropped to an OMS ?5, with a median time of 8 dys (95%CI 6-10) and 7 dys (95% CI 5-12) in SoC and BEV arms, respectively (HR 0.76 95%CI [0.46-1.26]). At D28, 9 pts (18.8%) (SoC) and 4 pts (8.5%) (BEV) were dead; 4 pts (SoC) and 7 pts (BEV) required HFNO, NIV or IMV. At D120, SAE occurred in 26 pts in SoC arm and 33 pts in BEV arm, with similar frequency of bleeding and PE in both arms.
Conclusions
Addition of BEV to SoC did not shorten the time to improve hypoxemia in severe COVID-19 pneumonia, as compared with Soc. Deaths were numerically lower in BEV. No negative safety signal was observed.