COVID-19 Soliris Expanded Access Protocol

• Conditions: Covid19

• Registration Number: NCT04802083
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified