A Study to Evaluate SOLIRIS® to Treat Participants with Coronavirus Disease 2019

Overview

About this study

Soliris, an effective and extensively studied terminal complement inhibitor with a well-established safety profile, is proposed as an emergency therapy for the treatment of participants who have a confirmed diagnosis of SARS-CoV-2 infection with a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome (ARDS). Soliris produces complete and sustained inhibition of C5-mediated terminal complement activity. It is hypothesized that treatment with Soliris could ameliorate COVID-19-induced lung injury, improve outcomes in participants with COVID-19 severe pneumonia, acute lung injury, or ARDS and, with supportive medical care, provide additional time for participants to recover.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males or females.
  • ≥ 18 years of age.
  • ≥ 40 kg at the time of providing informed consent.
  • Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
  • Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening.
  • Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation (WHO 2020).

Exclusion Criteria:

  • Confirmed diagnosis of SARS-CoV-2 infection presentig as mild-to-moderate COVID-19, eve if the participant is hospitalized.
  • Participant is not expected to survive more than 24 hours.
  • Participants has an unresolved Neisseria meningiditis infection.
  • Hypersensitiviy to murine proteins or one of the excipients of Soliris.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sean Pittock, M.D.

Open for enrollment

Contact information:

Katie Doane

DLCMSANResCoor@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available