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Clinical Trial
. 2024 Feb 23;11(4):ofae102.
doi: 10.1093/ofid/ofae102. eCollection 2024 Apr.

COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial

Michelle Le  1 , Lauren Khoury  2 , Yang Lu  3 , Connor Prosty  2 , Maxime Cormier  4 , Mathew P Cheng  5 , Robert Fowler  6 , Srinivas Murthy  7 , Jennifer L Y Tsang  8 , Moshe Ben-Shoshan  9 , Elham Rahme  3 , Shirin Golchi  3 , Nandini Dendukuri  3 , Todd C Lee  5 , Elena Netchiporouk  1
Affiliations
Clinical Trial

COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial

Michelle Le et al. Open Forum Infect Dis. .

Abstract

Background: Omalizumab is an anti-immunoglobulin E monoclonal antibody used to treat moderate to severe chronic idiopathic urticaria, asthma, and nasal polyps. Recent research suggested that omalizumab may enhance the innate antiviral response and have anti-inflammatory properties.

Objective: We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for coronavirus disease 2019 (COVID-19) pneumonia.

Methods: This was a phase II randomized, double blind, placebo-controlled trial comparing omalizumab with placebo (in addition to standard of care) in hospitalized patients with COVID-19. The primary endpoint was the composite of mechanical ventilation and/or death at day 14. Secondary endpoints included all-cause mortality at day 28, time to clinical improvement, and duration of hospitalization.

Results: Of 41 patients recruited, 40 were randomized (20 received the study drug and 20 placebo). The median age of the patients was 74 years and 55.0% were male. Omalizumab was associated with a 92.6% posterior probability of a reduction in mechanical ventilation and death on day 14 with an adjusted odds ratio of 0.11 (95% credible interval 0.002-2.05). Omalizumab was also associated with a 75.9% posterior probability of reduced all-cause mortality on day 28 with an adjusted odds ratio of 0.49 (95% credible interval, 0.06-3.90). No statistically significant differences were found for the time to clinical improvement and duration of hospitalization. Numerically fewer adverse events were reported in the omalizumab group and there were no drug-related serious adverse events.

Conclusions: These results suggest that omalizumab could prove protective against death and mechanical ventilation in hospitalized patients with COVID-19. This study could also support the development of a phase III trial program investigating the antiviral and anti-inflammatory effect of omalizumab for severe respiratory viral illnesses requiring hospital admission. ClinicalTrials.gov ID: NCT04720612.

Keywords: COVID-19; SARS-CoV2; acute respiratory distress syndrome; coronavirus; omalizumab.

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Conflict of interest statement

Potential conflicts of interest. M.L. reports funding support from the Canadian Institutes of Health Research (CIHR) Vanier Doctoral Scholarship. M.P.C. reports grants from the McGill Interdisciplinary Initiative in Infection and Immunity and personal fees from GEn1E Lifesciences (as a member of the scientific advisory board) and personal fees from nplex biosciences (as a member of the scientific advisory board). J.L.Y.T. reports a Physicians” Services Incorporated Foundation grant to her institution, outside the submitted work. She is cochair of the Canadian Community ICU Research Network (CCIRNet) and vice chair of the Quest Community Health Centre board of directors. S.M. reports a grant from the Health Research Foundation, Innovative Medicines Canada. M.B.S. reports salary support from Fonds de recherche du Québec—Santé and is part of the advisory Board or equivalent of: Bausch, Stallergenes, Novartis, & Sanofi. Participating or participated in a clinical trial: Novartis, Aimmune, & Sanofi. T.C.L. reports salary support from Fonds de recherche du Québec—Santé. E.N. has been an Advisory Board/Speaker/Consultant and/or received Investigator Initiated Educational and/or Research funding from AbbVie Inc., Bausch Health, Beiersdorf, Boehringer Ingelheim International, Bristol Myers Squibb, Eli Lilly, Galderma SA., Janssen Inc., LEO Pharma, Medexus, Novartis Pharmaceuticals, Pfizer Inc., Sanofi Genzyme, Sun Pharmaceuticals, and UCB. All other authors report no potential conflicts.

Figures

Figure 1.
Figure 1.
Participant flow diagram.
Figure 2.
Figure 2.
Posterior probability density plot illustrating adjusted odds ratio (aOR) for omalizumab in association with death or mechanical ventilation at day 14.
Figure 3.
Figure 3.
Unadjusted Kaplan-Meier plot depicting all-cause mortality up to 28 d comparing omalizumab and placebo groups.
See this image and copyright information in PMC

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