Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04369469 |
Recruitment Status :
Terminated
(Met futility bar at interim analysis.)
First Posted : April 30, 2020
Last Update Posted : September 22, 2021
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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 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 202 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 |
Actual Primary Completion Date : | February 8, 2021 |
Actual Study Completion Date : | April 8, 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:
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. |
- Survival (based on all-cause mortality) at Day 29 [ Time Frame: Baseline, Day 29 ]
- Number of days free of mechanical ventilation at Day 29 [ Time Frame: Baseline, Day 29 ]
- Duration of intensive care unit stay at Day 29 [ Time Frame: Baseline, Day 29 ]
- Change from baseline in Sequential Organ Failure Assessment at Day 29 [ Time Frame: Baseline, Day 29 ]
- Change from baseline in SpO2/FiO2 at Day 29 [ Time Frame: Baseline, Day 29 ]
- Duration of hospitalization at Day 29 [ Time Frame: Baseline, Day 29 ]
- Survival (based on all-cause mortality) at Day 60 and Day 90 [ Time Frame: Baseline, Day 60, Day 90 ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent
- Confirmed diagnosis of SARS-CoV-2 infection (eg, via polymerase chain reaction [PCR] and/or antibody test) presenting as severe COVID-19 requiring hospitalization
- 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
- 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])
- 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 (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias)
- Patient has an unresolved Neisseria meningitidis infection
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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
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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | September 22, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
acute lung injury acute respiratory distress syndrome antibodies, monoclonal, humanized COVID-19 hospitalization pneumonia severe pneumonia |
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COVID-19 Pneumonia Pneumonia, Viral Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Lung Injury Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Wounds and Injuries Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Ravulizumab Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |