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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369469
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Severe Pneumonia Acute Lung Injury Acute Respiratory Distress Syndrome Pneumonia, Viral Biological: Ravulizumab Other: Best Supportive Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Ravulizumab plus Best Supportive Care Biological: Ravulizumab
Weight-based doses of ravulizumab will be administered intravenously on Days 1, 5, 10, and 15.
Other Names:
  • Ultomiris
  • ALXN1210

Other: Best Supportive Care
Patients will receive medications, therapies, and interventions per standard hospital treatment protocols.

Best Supportive Care Other: Best Supportive Care
Patients will receive medications, therapies, and interventions per standard hospital treatment protocols.




Primary Outcome Measures :
  1. Survival (based on all-cause mortality) at Day 29 [ Time Frame: Baseline, Day 29 ]

Secondary Outcome Measures :
  1. Number of days free of mechanical ventilation at Day 29 [ Time Frame: Baseline, Day 29 ]
  2. Duration of intensive care unit stay at Day 29 [ Time Frame: Baseline, Day 29 ]
  3. Change from baseline in Sequential Organ Failure Assessment at Day 29 [ Time Frame: Baseline, Day 29 ]
  4. Change from baseline in SpO2/FiO2 at Day 29 [ Time Frame: Baseline, Day 29 ]
  5. Duration of hospitalization at Day 29 [ Time Frame: Baseline, Day 29 ]
  6. Survival (based on all-cause mortality) at Day 60 and Day 90 [ Time Frame: Baseline, Day 60, Day 90 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  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:

    • Current treatment with a complement inhibitor or
    • Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization on Day 1
  6. 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
  7. Female patients who are breastfeeding or who have a positive pregnancy test result at Screening
  8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins
  9. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369469


Contacts
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Contact: Alexion Pharmaceuticals, Inc. +1 855-752-2356 clinicaltrials@alexion.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Alexion Pharmaceuticals
Publications:
WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04369469    
Other Study ID Numbers: ALXN1210-COV-305
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals:
acute lung injury
acute respiratory distress syndrome
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
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Syndrome
Disease
Pathologic Processes
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Virus Diseases
Ravulizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs