Covid-19 has spread rapidly throughout the world causing widespread panic, death, andinjury. While this virus is the provocateur, it is often the patient's owndisproportionate 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 tocause 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 preventingthe formation of the membrane attack complex. By modulating this portion of the immuneresponse, mortality can be halted while the patient has time to recover from the viruswith 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should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal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.
Drug: Eculizumab
A distal complement inhibitor.
Inclusion Criteria:
- Age 18 or older.
- Confirmed Covid-19 infection
- ARDS
- ICU patient
Exclusion Criteria:
- Active Neisseria infection.
- Concomitant enrollment in another experimental/off-label immunosuppressive therapy
trial.
Thomas C Pitts, M.D.
6465967386
Drpitts@hudsonmedical.com