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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04355494
• Other study ID #: ECU-COV-401
• Status: No longer available

Study information

• Verified date: March 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• eculizumab
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)

Locations

Country	Name	City	State
France	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
United States	Boston Medical Center	Boston	Massachusetts
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
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	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,