SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
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|ClinicalTrials.gov Identifier: NCT04355494|
Expanded Access Status : Available
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment|
|COVID-19 Pneumonia, Viral Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)||Biological: eculizumab|
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|
|Official Title:||SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment|
- Biological: eculizumab
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)Other Name: Soliris
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355494
|Contact: Alexion Pharmaceuticals Inc.||email@example.com|
|Hôpital Henri Mondor||Available|
|Creteil, France, 94000|
|Hôpital Garches Raymond Poincaré||Available|
|Garches, France, 92380|
|Hôpital de Bicêtre||Available|
|Le Kremlin Bicêtre, France, 94275|
|Hôpital Saint Louis||Available|
|Paris, France, 75010|
|Hôpital Paul Brousse||Available|
|Villejuif, France, 94800|