Ravulizumab and COVID-19

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminal complement products and is proposed for the treatment of COVID-19 induced microvasculature injury and endothelial damage leading to thrombotic microangiopathy (TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants with a confirmed diagnosis of COVID-19 who clinically or diagnostically present with deteriorating renal function. Ravulizumab causes immediate and sustained inhibition of the terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 induced kidney injury due to TMA, shorten hospital stay, and improve the overall survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Ravulizumab

Criteria

Inclusion Criteria:

1. Males or Females 18 years of age or above and weighing 40kg or above at the time of providing informed consent.

2. A clinical diagnosis of thrombotic microangiopathy will then be applied to include the following criteria: i) D-dimer > 100% the upper limit of the reference range and ii) serum creatinine >25% of the normal range or iii) >25% increase from patient's baseline serum creatinine.

3. Diagnosis of SARS-CoV-2 infection within 90 days prior to enrollment

Exclusion Criteria:

1. Participant is not expected to survive more than 24 hours.

2. Participant has an unresolved Neisseria Meningitides infection.

3. Hypersensitivity to murine proteins or to one of the excipients of ravulizumab.