Phase 3 Open-label Randomized Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia Acute Lung Injury or Acute Respiratory Distress
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Covid
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Age: Between 18 - 99 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants able and willing to provide written informed consent for the study
- Participants who have confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
- Those who had severe pneumonia, acute lung injury, or ARDS confirmed by computed tomography (CT) or X-ray at Screening or within the 3 days prior to Screening, as part of the patient’s routine clinical care.
- Participants who had severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation with invasive or noninvasive mechanical ventilation
- Body weight = 40 kg at the time of providing informed consent.
- Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug
You may not be eligible for this study if the following are true:
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- Those who are not expected to survive for more than 24 hours.
- Participants on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening
- Severe pre-existing cardiac disease
- Participants who have an unresolved Neisseria meningitidis infection.
- Use of the following medications and therapies
- Current treatment with a complement inhibitor
- Rituximab within 3 months of Screening
- Mitoxantrone within 3 months of Screening
- Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening.
- Participating in another clinical study
- Participants who are pregnant or lactating
- Those who have history of hypersensitivity to any ingredient contained in the study drug
If you are registered as a volunteer, please login to the dashboard to send referrals.