Eculizumab (Soliris) in Covid-19 Infected Patients (SOLID-C19)
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|ClinicalTrials.gov Identifier: NCT04288713|
Expanded Access Status : Available
First Posted : February 28, 2020
Last Update Posted : March 30, 2020
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|Condition or disease||Intervention/treatment|
- Time in the ICU
- Time on a ventilator
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.
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 In that case, antibiotic therapy should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal vaccines (see ACIP guidelines in complement deficient patients).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 Type :||Expanded Access|
|Expanded Access Type :||Individual Patients, Treatment IND/Protocol|
|Official Title:||Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition.|
- Drug: Eculizumab
A distal complement inhibitor.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Age 18 or older.
- Confirmed Covid-19 infection
- ICU patient
- Active Neisseria infection.
- Concomitant enrollment in another experimental/off-label immunosuppressive therapy trial.
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): NCT04288713
|Contact: Thomas C Pitts, M.D.||6465967386||Drpitts@hudsonmedical.com|
|Responsible Party:||Thomas Pitts, M.D., Thomas C Pitts, M.D., Hudson Medical|
|Other Study ID Numbers:||
|First Posted:||February 28, 2020 Key Record Dates|
|Last Update Posted:||March 30, 2020|
|Last Verified:||March 2020|
Adult respiratory distress syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Complement Inactivating Agents
Physiological Effects of Drugs