NCT04288713

Brief 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. 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

First QC Date

February 27, 2020

Last Update Submit

March 26, 2020

Conditions

Coronavirus

Keywords

Covid19SolirisEculizumabCovid-19ComplementImmunomodulationARDSAdult respiratory distress syndromeCoronavirusCorona Virus

Interventions

EculizumabDRUG

A distal complement inhibitor.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older.
  • Confirmed Covid-19 infection
  • ARDS
  • ICU patient

You may not qualify if:

  • Active Neisseria infection.
  • Concomitant enrollment in another experimental/off-label immunosuppressive therapy trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30301856BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19Respiratory Distress Syndrome

Interventions

eculizumab

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Thomas C Pitts, M.D.

CONTACT

6465967386Drpitts@hudsonmedical.com

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thomas C Pitts, M.D.

Study Record Dates

First Submitted

February 27, 2020

First Posted

February 28, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03