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

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

• Registration Number: NCT04355494
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (12)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Newton-Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

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

Hôpital Saint Louis; 🇫🇷 Paris, France

Hôpital Garches Raymond Poincaré; 🇫🇷 Garches, France

Hôpital de Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States