COVID-19 Soliris Expanded Access Protocol

NCT04802083 | Unknown

• 1 other identifier: ECU-COV-402
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This protocol provides participants with COVID-19 access to Soliris.

Conditions

Covid19

Keywords

Soliris; eculizumab; C5 inhibitor; COVID-19; SARS-COV-2; acute lung injury; severe pneumonia; acute respiratory distress syndrome; severe acute respiratory syndrome coronavirus 2; severe acute respiratory syndrome; multi-organ injury; hospitalization; antibodies, monoclonal, humanized; emergency treatment; viral; expanded access

Interventions

Eculizumab BIOLOGICAL

Eculizumab 900-1200 mg will be administered intravenously.

Also known as: Soliris, monoclonal antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years of age and body weight ≥ 40 kg.
• Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
• Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1.
• In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.

You may not qualify if:

• Unresolved Neisseria meningitidis infection.
• Known hypersensitivity to murine proteins or to an excipient of Soliris.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

COVID-19; Acute Lung Injury; Pneumonia; Respiratory Distress Syndrome; Severe Acute Respiratory Syndrome

Interventions

eculizumab; Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Respiration Disorders

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 17, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09