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

March 5, 2021 updated by: Alexion Pharmaceuticals

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Hôpital Henri Mondor
      • Garches, France, 92380
        • Hôpital Garches Raymond Poincaré
      • Le Kremlin Bicêtre, France, 94275
        • Hopital de Bicetre
      • Paris, France, 75010
        • Hopital Saint Louis
      • Villejuif, France, 94800
        • Hopital Paul Brousse
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECU-COV-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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