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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355494
Expanded Access Status : Available
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

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

Condition or disease Intervention/treatment
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.

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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



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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Locations
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France
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
Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04355494    
Other Study ID Numbers: ECU-COV-401
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Keywords provided by Alexion Pharmaceuticals:
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
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Virus Diseases