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Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition

Trial Profile

Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 01 Apr 2020

At a glance

  • Drugs Eculizumab (Primary)
  • Indications COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Acronyms SOLID-C19
  • Most Recent Events

    • 03 Mar 2020 New trial record

Trial Overview

Purpose

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.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

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

Patient Exclusion Criteria

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

Trial Details

Identifiers

Identifier Owner
NCT04288713 ClinicalTrials.gov: US National Institutes of Health
COVID19 -

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Clinical Phase Unknown
  • Location USA
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
EculizumabPrimary Drug Intravenous Infusion

Drug: Eculizumab (A distal complement inhibitor.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Thomas C Pitts, M.D.
6465967386
Drpitts@hudsonmedical.com
show details
, Hudson Medical
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Hudson Medical
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-

Trial History

Event Date Event Type Comment
01 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 01 Apr 2020
03 Mar 2020 New trial record New trial record Updated 03 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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