COVID-19NCT04355494
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
A study testing eculizumab in people with COVID-19 and Pneumonia, Viral, run by Alexion Pharmaceuticals, Inc. at 12 sites in 2 countries.
Trial summary
This protocol provides access to eculizumab treatment for participants with severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- eculizumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 12 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
- Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
- Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
- Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation
Who cannot join
- Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
- Participant is not expected to survive more than 24 hours
- Participant has an unresolved Neisseria meningitidis infection
- Hypersensitivity to murine proteins or to one of the excipients of Soliris
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States7 sites
Boston Medical Center
Boston, Massachusetts, 02118
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Mayo Clinic
Rochester, Minnesota, 55905
France5 sites
Hôpital Henri Mondor
Créteil, 94000
Hôpital Garches Raymond Poincaré
Garches, 92380
Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Saint Louis
Paris, 75010
Hôpital Paul Brousse
Villejuif, 94800
About this study
Official title: SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
Read the detailed description
This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment).
The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized).
For each participant, the total duration of the program is anticipated to be 4.5 months.
- Being tested
- eculizumab
- Keywords
- acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, complement inhibition, COVID-19, eculizumab, emergency treatment, expanded access program, hospitalization, pneumonia, severe acute respiratory syndrome, severe acute respiratory syndrome coronavirus 2, severe pneumonia, Soliris, viral
- Medical subject headings
- COVID-19, Pneumonia, Viral, Acute Lung Injury, Respiratory Distress Syndrome, Pneumonia, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eculizumabBiological
Also called Soliris
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355494
- Sponsor's protocol ID
- ECU-COV-401
- Status last verified
- Mar 2021
- First submitted
- 17 Apr 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
Publications
Burwick RM, Dellapiana G, Newman RA, Smithson SD, Naqvi M, Williams J 3rd, Wong MS, Bautista M, Gaden A, Kazani SD, Dunn DA, Ma MH, Mitter S, Monteleone JPR, Ortiz SR, Ghandehari S, Merin N, Zakowski MI, Karumanchi SA. Complement blockade with eculizumab for treatment of severe Coronavirus Disease 2019 in pregnancy: A case series. Am J Reprod Immunol. 2022 Aug;88(2):e13559. doi: 10.1111/aji.13559. Epub 2022 May 12.
PubMed 35514201
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment
- ClinicalTrials.gov ID
- NCT04355494
- Acronym / sponsor ID
- ECU-COV-401
- Keywords
- acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, complement inhibition, COVID-19, eculizumab, emergency treatment, expanded access program
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
Detailed description
This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment).
The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized).
For each participant, the total duration of the program is anticipated to be 4.5 months.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
- Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
- Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
- Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation
Key exclusion criteria (4 listed)
- Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
- Participant is not expected to survive more than 24 hours
- Participant has an unresolved Neisseria meningitidis infection
- Hypersensitivity to murine proteins or to one of the excipients of Soliris
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 |
|---|---|---|
| eculizumabAlso: SolirisEculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 35514201Burwick RM, Dellapiana G, Newman RA, Smithson SD, Naqvi M, Williams J 3rd, Wong MS, Bautista M, Gaden A, Kazani SD, Dunn DA, Ma MH, Mitter S, Monteleone JPR, Ortiz SR, Ghandehari S, Merin N, Zakowski MI, Karumanchi SA. Complement blockade with eculizumab for treatment of severe Coronavirus Disease 2019 in pregnancy: A case series. Am J Reprod Immunol. 2022 Aug;88(2):e13559. doi: 10.1111/aji.13559. Epub 2022 May 12.
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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.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eculizumab in people with COVID-19 and Pneumonia, Viral, run by Alexion Pharmaceuticals, Inc. at 12 sites in 2 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355494, which also lists 1 linked publication.
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 9 Mar 2021.