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

No longer available
Intermediate-size Population
Pneumonia, Viral
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Biological: eculizumab

Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
Other Name: Soliris

Eligibility Criteria

Inclusion Criteria:

1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed

2. Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

Cedars-Sinai Medical Center
Los Angeles, California, United States

Boston Medical Center
Boston, Massachusetts, United States

Newton-Wellesley Hospital
Newton, Massachusetts, United States

Mayo Clinic
Rochester, Minnesota, United States

Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai
New York, New York, United States

The Ohio State University Wexner Medical Center
Columbus, Ohio, United States

Hôpital Henri Mondor
Creteil, France

Hôpital Garches Raymond Poincaré
Garches, France

Hôpital de Bicêtre
Le Kremlin Bicêtre, France

Hôpital Saint Louis
Paris, France

Hôpital Paul Brousse
Villejuif, France

Alexion Pharmaceuticals, Inc.
NCT Number
Acute Lung Injury
Acute Respiratory Distress Syndrome
antibodies, monoclonal, humanized
complement inhibition
emergency treatment
Expanded Access Program
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
severe pneumonia
MeSH Terms
Pneumonia, Viral
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury