Phase
Condition
Lung Injury
Acute Respiratory Distress Syndrome (Ards)
Respiratory Syncytial Virus (Rsv) Infection
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time ofproviding informed consent.
- 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.
- 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.
- Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airwaypressure or bilevel positive airway pressure).
- 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:
- Participant was not expected to survive for more than 24 hours.
- Participant was on invasive mechanical ventilation with intubation for more than 48hours prior to Screening.
- Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 orClass 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
- Participant had an unresolved Neisseria meningitidis infection.
- Used the following medications and therapies:
- Current treatment with a complement inhibitor or
- Intravenous immunoglobulin within 4 weeks prior to randomization on Day 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.
- Female participants who were breastfeeding or who have a positive pregnancy testresult at Screening.
- History of hypersensitivity to any ingredient contained in the study drug, includinghypersensitivity to murine proteins.
- 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
Connect with a study center
Hôpital Raymond Poincaré
Garches, Hauts De Seine 92380
FranceSite Not Available
Hôpital Henri Mondor
Créteil, Val De Marne 94000
FranceSite Not Available
Hôpital Bicêtre
Le Kremlin-Bicêtre cedex, Val De Marne 94275
FranceSite Not Available
Clinical Trial Site
Le Kremlin-Bicêtre, 94275
FranceSite Not Available
Clinical Trial Site
Paris, 75475
FranceSite Not Available
Hôpital Saint-Louis
Paris cedex, 75475
FranceSite Not Available
Jikei University Hospital
Minato-Ku, Tokyo 105-8471
JapanSite Not Available
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo 160-0023
JapanSite Not Available
Medical Hospital, Tokyo Medical and Dental University
Bunkyō-Ku, Tokyo-To 113-8519
JapanSite Not Available
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Barcelona 08907
SpainSite Not Available
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hammersmith Hospital
London, Greater London W12 0HS
United KingdomSite Not Available
King's College Hospital
London, Greater London SE5 9RS
United KingdomSite Not Available
Royal Liverpool University Hospital
Liverpool, Merseyside L7 8XP
United KingdomSite Not Available
Queen Elizabeth Hospital
Birmingham, West Midlands B15 2TH
United KingdomSite Not Available
St James's University Hospital
Leeds, West Yorkshire LS9 7TF
United KingdomSite Not Available
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas 72205
United StatesSite Not Available
LAC/USC Health Center
Los Angeles, California 90033
United StatesSite Not Available
UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
United StatesSite Not Available
Alternative Research Associates, LLC
Hialeah, Florida 33012
United StatesSite Not Available
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesSite Not Available
University of Florida
Jacksonville, Florida 32209
United StatesSite Not Available
Jupiter Medical Center
Jupiter, Florida 33458
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Norton Healthcare
Louisville, Kentucky 40241
United StatesSite Not Available
Overton Brooks VA Medical Center
Shreveport, Louisiana 71101
United StatesSite Not Available
Baltimore VA Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Mayo Clinic Health System
Mankato, Minnesota 56001
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
NYU Langone Health Center
New York, New York 10016
United StatesSite Not Available
Westchester Medical Center
Valhalla, New York 10595
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Baptist Memorial Hospital
Memphis, Tennessee 38120
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
VA Puget Sound Health Care System
Seattle, Washington 98108
United StatesSite Not Available
Mayo Clinic Health System in Eau Claire
Eau Claire, Wisconsin 54703
United StatesSite Not Available
Mayo Clinic Health System
La Crosse, Wisconsin 54601
United StatesSite Not Available
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