NCT04355494

SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19

SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This protocol provides access to eculizumab treatment for participants with severe COVID-19.

Detailed description

This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment). The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized). For each participant, the total duration of the program is anticipated to be 4.5 months.

Conditions

• COVID-19
• Pneumonia, Viral
• Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
BIOLOGICAL	eculizumab	Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)

Timeline

• First posted: 2020-04-21
• Last updated: 2021-03-09

Locations

12 sites across 2 countries: United States, France