COVID-19 Severe PneumoniaPhase 3NCT04369469

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

A Phase 3 study testing Ravulizumab and BSC in people with COVID-19 Severe Pneumonia and Acute Lung Injury, run by Alexion Pharmaceuticals, Inc. at 39 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome
What is being tested?: Ravulizumab and BSC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 39 sitesin 5 countries
Study dates: 10 May 2020to 8 Apr 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time of providing informed consent.
Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (for example, via polymerase chain reaction 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 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 airway pressure or bilevel positive airway pressure).
Female participants of childbearing potential and male participants with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.

Who cannot join

Participant was not expected to survive for more than 24 hours.
Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 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

Show all 13Show fewer

Intravenous immunoglobulin within 4 weeks prior to randomization on Day 1
Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever was greater. Exceptions:
Investigational therapies were allowed if received as part of BSC through an expanded access protocol or emergency approval for the treatment of COVID-19.
Investigational antiviral therapies (such as remdesivir) were allowed even if received as part of a clinical study.
Female participants who were 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.
Participant who was not currently vaccinated against Neisseria meningitidis, unless the participant 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 participant receives vaccination against Neisseria meningitidis.

Trial locations and contacts

39 sites in 5 countries.

Country

City, postcode or hospital

39 sites in 5 countries

United States24 sites

Baltimore VA Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
Henry Ford Hospital
Detroit, Michigan, 48202
Mayo Clinic Health System in Eau Claire
Eau Claire, Wisconsin, 54703
Houston Methodist Hospital
Houston, Texas, 77030
University of Florida
Jacksonville, Florida, 32209
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Health System
La Crosse, Wisconsin, 54601
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
LAC/USC Health Center
Los Angeles, California, 90033
Norton Healthcare
Louisville, Kentucky, 40241
Mayo Clinic Health System
Mankato, Minnesota, 56001
Baptist Memorial Hospital
Memphis, Tennessee, 38120
NYU Langone Health Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
UC Irvine Medical Center
Orange, California, 92868
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Westchester Medical Center
Valhalla, New York, 10595
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom5 sites

Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP
King's College Hospital
London, Greater London, SE5 9RS
Hammersmith Hospital
London, Greater London, W12 0HS

Other trials in United Kingdom

Spain4 sites

Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Ramon y Cajal
Madrid, 28034

Other trials in Spain

France3 sites

Hôpital Henri Mondor
Créteil, Val De Marne, 94000
Hôpital Raymond Poincaré
Garches, Hauts De Seine, 92380
Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94275

Other trials in France

Japan3 sites

Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, Tokyo-To, 113-8519
Jikei University Hospital
Minato-Ku, Tokyo, 105-8471
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023

Other trials in Japan

About this study

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

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.

Conditions: COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Viral
Being tested: Ravulizumab, BSC
Keywords: 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
Medical subject headings: Acute Lung Injury, Respiratory Distress Syndrome, Pneumonia, Viral, COVID-19, Pneumonia, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RavulizumabBiological
Also called Ultomiris, ALXN1210
Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15.
BSCOther
Participants received medications, therapies, and interventions per standard hospital treatment protocols.

Study groups in NCT04369469
Study group	Role	What they receive
Group 1 - Ravulizumab + BSC	Experimental	Not described Receives: Biological: Ravulizumab; Other: BSC
Group 2 - BSC alone	Other	Not described Receives: Other: BSC

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29
Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.
Measured: Day 29

Secondary outcomes (9)

Number Of Days Free Of Mechanical Ventilation At Day 29
The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation.
Measured: Day 29
Number of Days the Participants Were Alive and Not in ICU
The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented.
Measured: Day 1 through Day 29
Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29
Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition.
Measured: Baseline, Day 29
Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29
Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point.
Measured: Baseline, Day 29
Number of Days the Participants Were Alive and Not in the Hospital
The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented.
Measured: Day 1 through Day 29
Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90
For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section.
Measured: Up to Day 60 and Up to Day 90
Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29
Results are reported in micrograms/milliliter (μg/mL).
Measured: Day 1 and Day 29
Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29
Measured: Baseline, Day 29
Change From Baseline In Terminal Complement Complex C5b-9 At Day 29
Measured: Baseline, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 20208 Apr 2021

First posted30 Apr 2020
Study start10 May 2020
Primary completion8 Feb 2021
Study completion8 Apr 2021

Why it stopped: Met futility bar at interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for COVID-19 Severe PneumoniaStudies of the same condition, open and under way.
More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04369469
Sponsor's protocol ID: ALXN1210-COV-305
Status last verified: May 2022
First submitted: 28 Apr 2020
Last updated: 24 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Publications

WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.
McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7.
PubMed 33826106
Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. 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: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z.
PubMed 32660611
Annane D, Pittock SJ, Kulkarni HS, Pickering BW, Khoshnevis MR, Siegel JL, Powell CA, Castro P, Fujii T, Dunn D, Smith K, Mitter S, Kazani S, Kulasekararaj A. Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2023 Dec;11(12):1051-1063. doi: 10.1016/S2213-2600(23)00082-6. Epub 2023 Mar 20.
PubMed 36958364
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15):e140711. doi: 10.1172/jci.insight.140711.
PubMed 32554923

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 Severe Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04369469
Acronym / sponsor ID: ALXN1210-COV-305
Conditions: COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Viral
Keywords: acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, COVID-19, hospitalization, pneumonia, severe pneumonia, severe acute respiratory syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Met futility bar at interim analysis
Enrolment: 202 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 10 May 2020 (actual)
Primary completion: 8 Feb 2021 (actual)
Study completion: 8 Apr 2021 (actual)
First posted: 30 Apr 2020 (actual)
Results: Posted 24 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 - Ravulizumab + BSC	Experimental	Biological: Ravulizumab, Other: BSC
Group 2 - BSC alone	Other	Other: BSC

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time of providing informed consent.
Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (for example, via polymerase chain reaction 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 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 airway pressure or bilevel positive airway pressure).
Female participants of childbearing potential and male participants with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.

Key exclusion criteria (13 listed)

Participant was not expected to survive for more than 24 hours.
Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
Participant had an unresolved Neisseria meningitidis infection.
Used the following medications and therapies:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RavulizumabAlso: Ultomiris, ALXN1210Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15.	Biological	Group 1 - Ravulizumab + BSC
BSCParticipants received medications, therapies, and interventions per standard hospital treatment protocols.	Other	Group 1 - Ravulizumab + BSC, Group 2 - BSC alone

Primary outcome

Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29
Time frame: Day 29
Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.

9 secondary outcomes

Number Of Days Free Of Mechanical Ventilation At Day 29
Time frame: Day 29
Number of Days the Participants Were Alive and Not in ICU
Time frame: Day 1 through Day 29
Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29
Time frame: Baseline, Day 29
Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29
Time frame: Baseline, Day 29
Number of Days the Participants Were Alive and Not in the Hospital
Time frame: Day 1 through Day 29
Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90
Time frame: Up to Day 60 and Up to Day 90
Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29
Time frame: Day 1 and Day 29
Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29
Time frame: Baseline, Day 29
Change From Baseline In Terminal Complement Complex C5b-9 At Day 29
Time frame: Baseline, Day 29

Results and safety

Results posted to the registry on 24 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - Ravulizumab + BSC	135	125
Group 2 - BSC Alone	67	58

Primary outcome: Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29

Time frame: Day 29. Number. Unit: Percentage of participants

Measure	Group 1 - Ravulizumab + BSC n = 135	Group 2 - BSC Alone n = 66
Value	57.6	59.7

Group 1 - Ravulizumab + BSC vs Group 2 - BSC Alone: Risk Difference (RD): -0.0205 (95% CI -0.1703 to 0.1293), p = 0.6059, Mantel Haenszel

Population analysed: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 90. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - Ravulizumab + BSC	79 of 127 (62.2%)	97 of 127 (76.4%)	55 of 135
Group 2 - BSC Alone	38 of 67 (56.7%)	49 of 67 (73.1%)	25 of 66

Limitations and caveats (from the sponsor): Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundWHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.
Results publication: PubMed 33826106McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7.
Results publication: PubMed 32660611Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. 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: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z.
Derived from this study: PubMed 36958364Annane D, Pittock SJ, Kulkarni HS, Pickering BW, Khoshnevis MR, Siegel JL, Powell CA, Castro P, Fujii T, Dunn D, Smith K, Mitter S, Kazani S, Kulasekararaj A. Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2023 Dec;11(12):1051-1063. doi: 10.1016/S2213-2600(23)00082-6. Epub 2023 Mar 20.
Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Derived from this study: PubMed 32554923Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15):e140711. doi: 10.1172/jci.insight.140711.
Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

39 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ravulizumab and BSC in people with COVID-19 Severe Pneumonia and Acute Lung Injury, run by Alexion Pharmaceuticals, Inc. at 39 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, United Kingdom, Spain, France, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 (time frame: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04369469, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.