A Study to Evaluate the Effectiveness and Safety of Ravulizumab vs. Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome (Enrolling by Invitation Only)

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of Ravulizumab compared to Supportive Care in patients with COVID-19 severe pneumonia.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female.
  • Patient must be ≥ 18 years of age at the time of providing informed consent.
  • Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization.
  • 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.
  • Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation with invasive or noninvasive mechanical ventilation (WHO, 2020).
  • 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.

Exclusion Criteria:

  • Patient is not expected to survive for more than 24 hours.
  • Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
  • Severe pre-existing cardiac disease (i.e., New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
  • Patient has 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; and
    • Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening.
  • Participation in another interventional treatment study within 30 days before initiation of ravulizumab on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
  • Female patients who are breastfeeding or who have a positive pregnancy test result at Screening or on Day 1.
  • History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Mankato, Minn.

Mayo Clinic principal investigator

Syed Khan, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Amanda O'connor R.N.

(507) 594-6895

Oconnor.Amanda@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Joseph Poterucha, D.O.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Traci Heaney M.S.N., R.N.

(608) 392-6810

Heaney.Traci@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Siegel, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Heather Cissel

Cissel.Heather@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Sean Pittock, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Christina McCarthy

McCarthy.Christina@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Larry Lutwick, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cailyn Turner

(715) 464-8173

Turner.Cailyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20488594

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