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:

  • Conditions:
  • Age: Between 18 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants able and willing to provide written informed consent for the study
    2. Participants who have confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
    3. 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.
    4. Participants who had severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation with invasive or noninvasive mechanical ventilation
    5. Body weight = 40 kg at the time of providing informed consent.
    6. 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:

    1. Those who are not expected to survive for more than 24 hours.
    2. Participants on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening
    3. Severe pre-existing cardiac disease
    4. Participants who have an unresolved Neisseria meningitidis infection.
    5. 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.
    6. Participating in another clinical study
    7. Participants who are pregnant or lactating
    8. 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.