CoronavirusSOLID-C19NCT04288713
Eculizumab (Soliris) in Covid-19 Infected Patients
A study testing Eculizumab in people with Coronavirus, run by Hudson Medical.
Trial summary
Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- Eculizumab
- 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
- Age 18 or older.
- Confirmed Covid-19 infection
- ARDS
- ICU patient
Who cannot join
- Active Neisseria infection.
- Concomitant enrollment in another experimental/off-label immunosuppressive therapy trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition.
Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.
Read the detailed description
Recorded Endpoints:
- Mortality
- Time in the ICU
- Time on a ventilator
Administrative:
An Emergency FDA IND must be submitted (FDA form 3926) for each patient.
Subsequent to approval the primary investigator will obtain an authorization letter from Alexion Pharmaceuticals.
Implementation:
Prior to dosing the patient must receive ceftriaxone IV and this must be continued during the entire duration of therapy (vaccination will be mentioned shortly and is the only exception to prophylactic antibiotic coverage). If there is a clinical reason why the patient cannot receive Ceftriaxone (allergy, supply, etc) then an alternative prophylactic antibiotic covering Neisseria meningitis must be given for the duration of therapy. The SeroB and Quadrivalent meningococcal vaccines can be given if the duration of antibiotic therapy becomes unsafe or unfeasible. In that case, antibiotic therapy should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal vaccines (see ACIP guidelines in complement deficient patients). It is preferred that vaccination is avoided while the patient is acutely ill and that prophylactic antibiotics are used as meningococcal vaccination can upregulate the immune system possibly worsening the patient's condition.
Standard dosing protocol - Eculizumab 900mg IV every 7 days. Eculizumab is given IV over 30 minutes without the need of a pump (although one can be used if available).
Supplemental doses of eculizumab can be given if clinically warranted at the discretion of the investigator and clinical team.
The team should perform Murray scores daily for the first 72 hours THEN every other day unless a change is deemed necessary by the attending physician. (table 2)
Complement blood levels should be drawn every 72 hours. They may be drawn sooner if there is clinical inquiry which would affect clinical decision making and/or after a dose of Eculizumab is given.
The duration of therapy is at the discretion of the clinical team and investigator.
Follow up at day 7, 14, and 28 after discharge.
- Conditions
- Coronavirus
- Being tested
- Eculizumab
- Keywords
- Covid19, Soliris, Eculizumab, Covid-19, Complement, Immunomodulation, ARDS, Adult respiratory distress syndrome, Coronavirus, Corona Virus
- Medical subject headings
- Coronavirus Infections, COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
A distal complement inhibitor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 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 CoronavirusStudies of the same condition, open and under way.
- 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
- Hudson Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Pitts, M.D., Hudson Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288713
- Sponsor's protocol ID
- COVID19
- Acronym
- SOLID-C19
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
Publications
Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
PubMed 30301856
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition.
- ClinicalTrials.gov ID
- NCT04288713
- Acronym / sponsor ID
- SOLID-C19 / COVID19
- Conditions
- Coronavirus
- Keywords
- Covid19, Soliris, Eculizumab, Covid-19, Complement, Immunomodulation, ARDS, Adult respiratory distress syndrome
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Hudson MedicalUniversity, hospital or other
- First posted
- 28 Feb 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.
Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.
Detailed description
Recorded Endpoints:
- Mortality
- Time in the ICU
- Time on a ventilator
Administrative:
An Emergency FDA IND must be submitted (FDA form 3926) for each patient.
Subsequent to approval the primary investigator will obtain an authorization letter from Alexion Pharmaceuticals.
Implementation:
Prior to dosing the patient must receive ceftriaxone IV and this must be continued during the entire duration of therapy (vaccination will be mentioned shortly and is the only exception to prophylactic antibiotic coverage). If there is a clinical reason why the patient cannot receive Ceftriaxone (allergy, supply, etc) then an alternative prophylactic antibiotic covering Neisseria meningitis must be given for the duration of therapy. The SeroB and Quadrivalent meningococcal vaccines can be given if the duration of antibiotic therapy becomes unsafe or unfeasible. In that case, antibiotic therapy should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal vaccines (see ACIP guidelines in complement deficient patients). It is preferred that vaccination is avoided while the patient is acutely ill and that prophylactic antibiotics are used as meningococcal vaccination can upregulate the immune system possibly worsening the patient's condition.
Standard dosing protocol - Eculizumab 900mg IV every 7 days. Eculizumab is given IV over 30 minutes without the need of a pump (although one can be used if available).
Supplemental doses of eculizumab can be given if clinically warranted at the discretion of the investigator and clinical team.
The team should perform Murray scores daily for the first 72 hours THEN every other day unless a change is deemed necessary by the attending physician. (table 2)
Complement blood levels should be drawn every 72 hours. They may be drawn sooner if there is clinical inquiry which would affect clinical decision making and/or after a dose of Eculizumab is given.
The duration of therapy is at the discretion of the clinical team and investigator.
Follow up at day 7, 14, and 28 after discharge.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older.
- Confirmed Covid-19 infection
- ARDS
- ICU patient
Key exclusion criteria (2 listed)
- Active Neisseria infection.
- Concomitant enrollment in another experimental/off-label immunosuppressive therapy trial.
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 |
|---|---|---|
| EculizumabA distal complement inhibitor. | Drug | – |
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 30 Mar 2020.
- Background: PubMed 30301856Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Eculizumab in people with Coronavirus, run by Hudson Medical.
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 30 Mar 2020. 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?
Contact Thomas C Pitts, M.D. (6465967386, Drpitts@hudsonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288713, 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 30 Mar 2020.