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

Sponsor

Alexion Pharmaceuticals (Industry)

Overall Status

No longer available

CT.gov ID

NCT04355494

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia, Viral Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)	Biological: eculizumab

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 Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation

Exclusion Criteria:

Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
Participant is not expected to survive more than 24 hours
Participant has an unresolved Neisseria meningitidis infection
Hypersensitivity to murine proteins or to one of the excipients of Soliris

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Boston Medical Center	Boston	Massachusetts	United States	02118
3	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
4	Mayo Clinic	Rochester	Minnesota	United States	55905
5	Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901
6	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
7	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
8	Hôpital Henri Mondor	Creteil		France	94000
9	Hôpital Garches Raymond Poincaré	Garches		France	92380
10	Hôpital de Bicêtre	Le Kremlin Bicêtre		France	94275
11	Hôpital Saint Louis	Paris		France	75010
12	Hôpital Paul Brousse	Villejuif		France	94800