COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
|---|---|
| Enthalten in: |
Open forum infectious diseases - 11(2024), 4 vom: 27. Apr., Seite ofae102 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Le, Michelle [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Acute respiratory distress syndrome |
|---|
| Anmerkungen: |
Date Revised 03.04.2024 published: Electronic-eCollection ClinicalTrials.gov: NCT04720612 Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1093/ofid/ofae102 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370501020 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370501020 | ||
| 003 | DE-627 | ||
| 005 | 20240404000215.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240403s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/ofid/ofae102 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1363.xml |
| 035 | |a (DE-627)NLM370501020 | ||
| 035 | |a (NLM)38560604 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Le, Michelle |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 03.04.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT04720612 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. | ||
| 520 | |a 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 | ||
| 520 | |a Objective: We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for coronavirus disease 2019 (COVID-19) pneumonia | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV2 | |
| 650 | 4 | |a acute respiratory distress syndrome | |
| 650 | 4 | |a coronavirus | |
| 650 | 4 | |a omalizumab | |
| 700 | 1 | |a Khoury, Lauren |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Prosty, Connor |e verfasserin |4 aut | |
| 700 | 1 | |a Cormier, Maxime |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Mathew P |e verfasserin |4 aut | |
| 700 | 1 | |a Fowler, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Murthy, Srinivas |e verfasserin |4 aut | |
| 700 | 1 | |a Tsang, Jennifer L Y |e verfasserin |4 aut | |
| 700 | 1 | |a Ben-Shoshan, Moshe |e verfasserin |4 aut | |
| 700 | 1 | |a Rahme, Elham |e verfasserin |4 aut | |
| 700 | 1 | |a Golchi, Shirin |e verfasserin |4 aut | |
| 700 | 1 | |a Dendukuri, Nandini |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Todd C |e verfasserin |4 aut | |
| 700 | 1 | |a Netchiporouk, Elena |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Open forum infectious diseases |d 2014 |g 11(2024), 4 vom: 27. Apr., Seite ofae102 |w (DE-627)NLM243576811 |x 2328-8957 |7 nnns |
| 773 | 1 | 8 | |g volume:11 |g year:2024 |g number:4 |g day:27 |g month:04 |g pages:ofae102 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/ofid/ofae102 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 11 |j 2024 |e 4 |b 27 |c 04 |h ofae102 | ||