Coronavirus Clinical Trial
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.
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 In that case, antibiotic therapy should be withdrawn no sooner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.
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