Covid19NCT04802083
COVID-19 Soliris Expanded Access Protocol
A study testing Eculizumab in people with Covid19, run by Alexion Pharmaceuticals, Inc..
Trial summary
This protocol provides participants with COVID-19 access to Soliris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Eculizumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- 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 body weight ≥ 40 kg.
- Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
- Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1.
- In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.
Who cannot join
- Unresolved Neisseria meningitidis infection.
- Known hypersensitivity to murine proteins or to an excipient of Soliris.
About this study
Official title: SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol
This protocol provides participants with COVID-19 access to Soliris.
Read the detailed description
This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.
- Conditions
- Covid19
- Being tested
- Eculizumab
- Keywords
- Soliris, eculizumab, C5 inhibitor, COVID-19, SARS-COV-2, acute lung injury, severe pneumonia, acute respiratory distress syndrome, severe acute respiratory syndrome coronavirus 2, severe acute respiratory syndrome, multi-organ injury, hospitalization, antibodies, monoclonal, humanized, emergency treatment, viral, expanded access
- Medical subject headings
- COVID-19, Acute Lung Injury, Pneumonia, Respiratory Distress Syndrome, 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, monoclonal antibody
Eculizumab 900-1200 mg will be administered intravenously.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- NCT04802083
- Sponsor's protocol ID
- ECU-COV-402
- Status last verified
- Sep 2021
- First submitted
- 17 Feb 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 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 Protocol
- ClinicalTrials.gov ID
- NCT04802083
- Acronym / sponsor ID
- ECU-COV-402
- Conditions
- Covid19
- Keywords
- Soliris, eculizumab, C5 inhibitor, COVID-19, SARS-COV-2, acute lung injury, severe pneumonia, acute respiratory distress syndrome
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 17 Mar 2021 (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 participants with COVID-19 access to Soliris.
Detailed description
This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.
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 body weight ≥ 40 kg.
- Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
- Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1.
- In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.
Key exclusion criteria (2 listed)
- Unresolved Neisseria meningitidis infection.
- Known hypersensitivity to murine proteins or to an excipient 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: Soliris, monoclonal antibodyEculizumab 900-1200 mg will be administered intravenously. | 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 4 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Eculizumab in people with Covid19, run by Alexion Pharmaceuticals, Inc..
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 2 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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 4 Oct 2021.