Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.

Official Title

A 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 Syndrome

Keywords

COVID-19 Severe Pneumonia Acute Lung Injury Acute Respiratory Distress Syndrome Pneumonia, Viral antibodies, monoclonal, humanized COVID-19 hospitalization pneumonia severe pneumonia severe acute respiratory syndrome severe acute respiratory syndrome coronavirus 2 randomized controlled study ravulizumab respiratory distress syndrome, adult Ultomiris viral Respiratory Distress Syndrome, Newborn Lung Injury Syndrome Best Supportive Care

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent
  2. Confirmed diagnosis of SARS-CoV-2 infection (eg, via polymerase chain reaction [PCR] and/or antibody test) presenting as severe COVID-19 requiring hospitalization
  3. Severe pneumonia, acute lung injury, or acute respiratory distress syndrome 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. Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP])
  5. 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 CAN'T join if...

  1. Patient is not expected to survive for more than 24 hours
  2. Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening
  3. Severe pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias)
  4. Patient has an unresolved Neisseria meningitidis infection
  5. Use of the following medications and therapies:
  6. Current treatment with a complement inhibitor or
  7. Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization on Day 1
  8. Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever is greater

Exceptions:

  • Investigational therapies will be allowed if received as part of best supportive care through an expanded access protocol or emergency approval for the treatment of COVID-19
  • Investigational antiviral therapies (such as remdesivir) will be allowed even if received as part of a clinical study
  • Female patients who are breastfeeding or who have a positive pregnancy test result at Screening
  • History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins
  • Patient who is not currently vaccinated against N. meningitidis, unless the patient agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the patient receives vaccination against N. meningitidis

Locations

  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • LAC/USC Health Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals
ID
NCT04369469
Phase
Phase 3
Study Type
Interventional
Last Updated