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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 5368361, California 5332921 90048

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118

Newton-Wellesley Hospital
Newton 4945283, Massachusetts 6254926 02462

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Robert Wood Johnson University Hospital
New Brunswick 5101717, New Jersey 5101760 08901

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.