Eculizumab (Soliris) in Covid-19 Infected Patients

Studies

Study First Submitted Date 2020-02-27
Study First Posted Date 2020-02-28
Last Update Posted Date 2020-03-30
Verification Month Year March 2020
Verification Date 2020-03-31
Last Update Posted Date 2020-03-30

Detailed Descriptions

Sequence: 20650198
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 In that case, antibiotic therapy should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal vaccines (see ACIP guidelines in complement deficient patients).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.

Browse Interventions

Sequence: 95693900 Sequence: 95693901 Sequence: 95693902 Sequence: 95693903 Sequence: 95693904
Mesh Term Eculizumab Mesh Term Complement Inactivating Agents Mesh Term Immunosuppressive Agents Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs
Downcase Mesh Term eculizumab Downcase Mesh Term complement inactivating agents Downcase Mesh Term immunosuppressive agents Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51986213
Name Coronavirus
Downcase Name coronavirus

Id Information

Sequence: 40014490
Id Source org_study_id
Id Value COVID19

Interventions

Sequence: 52297728
Intervention Type Drug
Name Eculizumab
Description A distal complement inhibitor.

Keywords

Sequence: 79576323 Sequence: 79576324 Sequence: 79576325 Sequence: 79576326 Sequence: 79576327 Sequence: 79576328 Sequence: 79576329 Sequence: 79576330 Sequence: 79576331 Sequence: 79576332
Name Covid19 Name Soliris Name Eculizumab Name Covid-19 Name Complement Name Immunomodulation Name ARDS Name Adult respiratory distress syndrome Name Coronavirus Name Corona Virus
Downcase Name covid19 Downcase Name soliris Downcase Name eculizumab Downcase Name covid-19 Downcase Name complement Downcase Name immunomodulation Downcase Name ards Downcase Name adult respiratory distress syndrome Downcase Name coronavirus Downcase Name corona virus

Browse Conditions

Sequence: 192754870 Sequence: 192754871 Sequence: 192754872 Sequence: 192754873 Sequence: 192754874 Sequence: 192754875 Sequence: 192754876 Sequence: 192754877 Sequence: 192754878 Sequence: 192754879 Sequence: 192754880 Sequence: 192754881
Mesh Term COVID-19 Mesh Term Coronavirus Infections Mesh Term Pneumonia, Viral Mesh Term Pneumonia Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Virus Diseases Mesh Term Coronaviridae Infections Mesh Term Nidovirales Infections Mesh Term RNA Virus Infections Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term covid-19 Downcase Mesh Term coronavirus infections Downcase Mesh Term pneumonia, viral Downcase Mesh Term pneumonia Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term virus diseases Downcase Mesh Term coronaviridae infections Downcase Mesh Term nidovirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48145835
Agency Class OTHER
Lead Or Collaborator lead
Name Hudson Medical

Central Contacts

Sequence: 11967382
Contact Type primary
Name Thomas C Pitts, M.D.
Phone 6465967386
Email Drpitts@hudsonmedical.com
Role Contact

Eligibilities

Sequence: 30656576
Gender All
Minimum Age 18 Years
Maximum Age N/A
Criteria 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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254264824
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Responsible Parties

Sequence: 28769935
Responsible Party Type Principal Investigator
Name Thomas Pitts, M.D.
Title Thomas C Pitts, M.D.
Affiliation Hudson Medical

Study References

Sequence: 51870669
Pmid 30301856
Reference Type background
Citation 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.