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NCT04802083 Clinical Trial

COVID-19 Soliris Expanded Access Protocol

Covid19 Clinical Trial

Official title:
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04802083
Other study ID # ECU-COV-402
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2021
Source Alexion Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Eculizumab
Eculizumab 900-1200 mg will be administered intravenously.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alexion Pharmaceuticals
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