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Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial

Annane et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(23)00082-6, ALXN1210-COV-305, NCT04369469
Mar 2023  
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Mortality -8% Improvement Relative Risk Ravulizumab  ALXN1210-COV-305  VENTILATED PATIENTS  RCT Is late treatment with ravulizumab beneficial for COVID-19? RCT 201 patients in multiple countries (May 2020 - January 2021) No significant difference in mortality c19early.org Annane et al., The Lancet Respiratory .., Mar 2023 Favorsravulizumab Favorscontrol 0 0.5 1 1.5 2+
RCT 201 mechanically ventilated patients with severe COVID-19 showing no significant difference in mortality with ravulizumab. The study was terminated early due to futility.
risk of death, 7.6% higher, RR 1.08, p = 0.76, treatment 55 of 135 (40.7%), control 25 of 66 (37.9%), day 90.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Annane et al., 20 Mar 2023, Randomized Controlled Trial, multiple countries, peer-reviewed, mean age 63.0, 14 authors, study period 10 May, 2020 - 13 January, 2021, average treatment delay 12.4 days, trial NCT04369469 (history) (ALXN1210-COV-305). Contact: austin.kulasekararaj@nhs.net.
This PaperRavulizumabAll
Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial
Djillali Annane, Sean J Pittock, Hrishikesh S Kulkarni, Brian W Pickering, Matt R Khoshnevis, Jason L Siegel, Charles A Powell, Pedro Castro, Tomoko Fujii, Derek Dunn, Keisha Smith, Sanjay Mitter, MD Shamsah Kazani, Dr Austin Kulasekararaj
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(23)00082-6
Background The complement pathway is a potential target for the treatment of severe COVID-19. We evaluated the safety and efficacy of ravulizumab, a terminal complement C5 inhibitor, in patients hospitalised with severe COVID-19 requiring invasive or non-invasive mechanical ventilation. Methods This phase 3, multicentre, open-label, randomised controlled trial (ALXN1210-COV-305) enrolled adult patients (aged ≥18 years) from 31 hospitals in France, Japan, Spain, the UK, and the USA. Eligible patients had a confirmed diagnosis of SARS-CoV-2 that required hospitalisation and either invasive or non-invasive mechanical ventilation, with severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by CT scan or x-ray. We randomly assigned participants (2:1) to receive intravenous ravulizumab plus best supportive care (BSC) or BSC alone using a web-based interactive response system. Randomisation was in permuted blocks of six with stratification by intubation status. Bodyweight-based intravenous doses of ravulizumab were administered on days 1, 5, 10, and 15. The primary efficacy endpoint was survival based on all-cause mortality at day 29 in the intentionto-treat (ITT) population. Safety endpoints were analysed in all randomly assigned patients in the ravulizumab plus BSC group who received at least one dose of ravulizumab, and in all randomly assigned patients in the BSC group. The trial is registered with ClinicalTrials.gov, NCT04369469, and was terminated at interim analysis due to futility. Findings Between May 10, 2020, and Jan 13, 2021, 202 patients were enrolled in the study and randomly assigned to ravulizumab plus BSC or BSC. 201 patients were included in the ITT population (135 in the ravulizumab plus BSC group and 66 in the BSC group). The ravulizumab plus BSC group comprised 96 (71%) men and 39 (29%) women with a mean age of 63•2 years (SD 13•23); the BSC group comprised 43 (65%) men and 23 (35%) women with a mean age of 63•5 years (12•40). Most patients (113 [84%] of 135 in the ravulizumab plus BSC group and 53 [80%] of 66 in the BSC group) were on invasive mechanical ventilation at baseline. Overall survival estimates based on multiple imputation were 58% for patients receiving ravulizumab plus BSC and 60% for patients receiving BSC (Mantel-Haenszel analysis: risk difference -0•0205; 95% CI -0•1703 to 0•1293; one-sided p=0•61). In the safety population, 113 (89%) of 127 patients in the ravulizumab plus BSC group and 56 (84%) of 67 in the BSC group had a treatmentemergent adverse event. Of these events, infections and infestations (73 [57%] vs 24 [36%] patients) and vascular disorders (39 [31%] vs 12 [18%]) were observed more frequently in the ravulizumab plus BSC group than in the BSC group. Five patients had serious adverse events considered to be related to ravulizumab. These events were bacteraemia, thrombocytopenia, oesophageal haemorrhage, cryptococcal pneumonia, and pyrexia (in one patient each)...
Data sharing Alexion, AstraZeneca Rare Disease will consider requests for disclosure of clinical study participant-level data provided that participant privacy is assured by methods such as data de-identification, pseudonymisation, or anonymisation (as required by applicable law), and if such disclosure was included in the relevant study informed consent form or similar documentation. Qualified academic investigators can request participant-level clinical data and supporting documents (statistical analysis and protocol) pertaining to Alexion-sponsored studies. Further details regarding data availability and instructions for requesting information are available in the Alexion Clinical Trials Disclosure and Transparency Policy at https://alexionclinicaltrials.com/Disclosure-and-Transparency-Policy. The data request form is available at https://alexion.com/contact-alexion/medical-information.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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