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

Purpose

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

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent. 2. Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization 3. Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening 4. Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation

Exclusion Criteria

  1. Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized 2. Participant is not expected to survive more than 24 hours 3. Participant has an unresolved Neisseria meningitidis infection 4. Hypersensitivity to murine proteins or to one of the excipients of Soliris

Study Design

Phase
Study Type
Expanded Access

Recruiting Locations

Cedars-Sinai Medical Center
Los Angeles, California 90048

Boston Medical Center
Boston, Massachusetts 02118

Newton-Wellesley Hospital
Newton, Massachusetts 02462

Mayo Clinic
Rochester, Minnesota 55905

Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901

Icahn School of Medicine at Mount Sinai
New York, New York 10029

The Ohio State University Wexner Medical Center
Columbus, Ohio 43210

More Details

NCT ID
NCT04355494
Status
No longer available
Sponsor
Alexion Pharmaceuticals, Inc.

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.