Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

Last updated: May 4, 2022
Sponsor: Alexion Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT04369469
ALXN1210-COV-305
  • Ages > 18
  • All Genders

Study Summary

This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time ofproviding informed consent.
  2. Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (forexample, via polymerase chain reaction and/or antibody test) presenting as severeCOVID-19 requiring hospitalization.
  3. Severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmedby computed tomography or X-ray at Screening or within the 3 days prior to Screening,as part of the participant's routine clinical care.
  4. Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airwaypressure or bilevel positive airway pressure).
  5. Female participants of childbearing potential and male participants with femalepartners of childbearing potential must follow protocol specified contraceptionguidance for avoiding pregnancy for 8 months after treatment with the study drug.

Exclusion

Exclusion Criteria:

  1. Participant was not expected to survive for more than 24 hours.
  2. Participant was on invasive mechanical ventilation with intubation for more than 48hours prior to Screening.
  3. Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 orClass 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
  4. Participant had an unresolved Neisseria meningitidis infection.
  5. Used the following medications and therapies:
  • Current treatment with a complement inhibitor or
  • Intravenous immunoglobulin within 4 weeks prior to randomization on Day 1
  1. Treatment with investigational therapy in a clinical study within 30 days beforerandomization, or within 5 half-lives of that investigational therapy, whichever wasgreater. Exceptions:
  • Investigational therapies were allowed if received as part of BSC through anexpanded access protocol or emergency approval for the treatment of COVID-19.
  • Investigational antiviral therapies (such as remdesivir) were allowed even ifreceived as part of a clinical study.
  1. Female participants who were breastfeeding or who have a positive pregnancy testresult at Screening.
  2. History of hypersensitivity to any ingredient contained in the study drug, includinghypersensitivity to murine proteins.
  3. Participant who was not currently vaccinated against Neisseria meningitidis, unlessthe participant agrees to receive prophylactic treatment with appropriate antibioticsfor at least 8 months after the last infusion of study drug or until at least 2 weeksafter the participant receives vaccination against Neisseria meningitidis.

Study Design

Total Participants: 202
Study Start date:
May 10, 2020
Estimated Completion Date:
April 08, 2021

Connect with a study center

  • Hôpital Raymond Poincaré

    Garches, Hauts De Seine 92380
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, Val De Marne 94000
    France

    Site Not Available

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre cedex, Val De Marne 94275
    France

    Site Not Available

  • Clinical Trial Site

    Le Kremlin-Bicêtre, 94275
    France

    Site Not Available

  • Clinical Trial Site

    Paris, 75475
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris cedex, 75475
    France

    Site Not Available

  • Jikei University Hospital

    Minato-Ku, Tokyo 105-8471
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Medical Hospital, Tokyo Medical and Dental University

    Bunkyō-Ku, Tokyo-To 113-8519
    Japan

    Site Not Available

  • Hospital Universitari de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hammersmith Hospital

    London, Greater London W12 0HS
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool, Merseyside L7 8XP
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, West Midlands B15 2TH
    United Kingdom

    Site Not Available

  • St James's University Hospital

    Leeds, West Yorkshire LS9 7TF
    United Kingdom

    Site Not Available

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • LAC/USC Health Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Alternative Research Associates, LLC

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Florida

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Jupiter Medical Center

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Norton Healthcare

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Overton Brooks VA Medical Center

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Baltimore VA Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Mayo Clinic Health System

    Mankato, Minnesota 56001
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Health Center

    New York, New York 10016
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Baptist Memorial Hospital

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • VA Puget Sound Health Care System

    Seattle, Washington 98108
    United States

    Site Not Available

  • Mayo Clinic Health System in Eau Claire

    Eau Claire, Wisconsin 54703
    United States

    Site Not Available

  • Mayo Clinic Health System

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

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