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.

Available
Intermediate-size Population
COVID-19
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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
France
Contacts

Alexion Pharmaceuticals Inc.
1-855-752-2356
clinicaltrials@alexion.com

Alexion Pharmaceuticals
NCT Number
Keywords
Acute Lung Injury
Acute Respiratory Distress Syndrome
Antibodies
Monoclonal
humanized
complement inhibition
Covid-19
Eculizumab
emergency treatment
Expanded Access Program
hospitalization
Pneumonia
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
severe pneumonia
Soliris
Viral
MeSH Terms
Pneumonia, Viral
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Syndrome