COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)
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- STATUS
- Recruiting
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- End date
- Jul 17, 2023
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- participants needed
- 200
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- sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Summary
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.
Description
Coronavirus disease 2019 (COVID-19) has affected over 88 million people, resulting in the death of at least 1.9 million individuals and numbers continue to climb exponentially. Despite these staggering numbers, there are currently very few effective treatments for COVID-19. The immune response to COVID-19 virus appears to follow 2 phases. During the incubation and early disease, interferon (ex. INF-α) signaling and adaptive immunity preclude the disease from progressing. If, and when, this immune response is impaired, the virus may cause pathologic inflammation leading to massive organ dysfunction leading to acute respiratory distress syndrome (ARDS).
Omalizumab is a humanized anti-IgE antibody approved by Health Canada for the treatment of moderate-severe asthma and chronic spontaneous urticaria. Omalizumab has been shown to exhibit antiviral and anti-inflammatory effects in virally exacerbated asthma cases that may be relevant to the treatment of COVID-19.
This is a double blind randomized placebo-controlled trial to evaluate the efficacy of a single dose of omalizumab in reducing all cause mortality at day 29 in severe hospitalized COVID-19 cases. Moreover, time to improvement/hospital discharge, incidence and duration of mechanical ventilation and safety will be assessed.
Details
| Condition | Covid19 |
|---|---|
| Treatment | Placebo, omalizumab |
| Clinical Study Identifier | NCT04720612 |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Last Modified on | 4 October 2022 |
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