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COVID-19 Soliris Expanded Access Protocol

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ClinicalTrials.gov Identifier: NCT04802083
Expanded Access Status : Available
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
This protocol provides participants with COVID-19 access to Soliris.

Condition or disease Intervention/treatment
Covid19 Biological: Eculizumab

Detailed Description:
This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.

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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 Protocol



Intervention Details:
  • Biological: Eculizumab
    Eculizumab 900-1200 mg will be administered intravenously.
    Other Name: Soliris, monoclonal antibody

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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 body weight ≥ 40 kg.
  2. Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
  3. Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1.
  4. In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.

Exclusion Criteria:

  1. Unresolved Neisseria meningitidis infection.
  2. Known hypersensitivity to murine proteins or to an excipient 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): NCT04802083


Contacts
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Contact: Alexion Pharmaceuticals, Inc. 855-75202356 alexionaccess@alexion.com

Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04802083    
Other Study ID Numbers: ECU-COV-402
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: February 2021
Keywords provided by Alexion Pharmaceuticals:
Soliris
eculizumab
C5 inhibitor
COVID-19
SARS-COV-2
acute lung injury
severe pneumonia
acute respiratory distress syndrome
severe acute respiratory syndrome coronavirus 2
severe acute respiratory syndrome
multi-organ injury
hospitalization
antibodies, monoclonal, humanized
emergency treatment
viral
expanded access
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Eculizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs