Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition
Latest Information Update: 01 Apr 2020
At a glance
- Drugs Eculizumab (Primary)
- Indications COVID 2019 infections
- Focus Expanded access; Therapeutic Use
- Acronyms SOLID-C19
- 03 Mar 2020 New trial record
Most Recent Events
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
show details
Drpitts@hudsonmedical.com |
, Hudson Medical |
-
|
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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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