An expanded access record providing eculizumab in COVID-19, Pneumonia, Viral and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), sponsored by Alexion Pharmaceuticals, Inc.. No longer available at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Alexion Pharmaceuticals, Inc. · Expanded access
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
Also known as: Soliris
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
No contact was published for this record. The registry link below has the sponsor’s details.
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Alexion Pharmaceuticals, Inc.