Ravulizumab and COVID-19

NCT04570397 | Unknown Phase 3 FDA Drug

• 1 other identifier: 092420
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Thrombotic Microangiopathies; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of ravulizumab to ameliorate SARS-CoV-2 (COVID-19)-induced acute kidney injury manifesting as thrombotic microangiopathy.

  50% improvement in estimated glomerular filtration rate compared to conventional therapy within 30 days of treatment for COVID-19-induced acute kidney injury.

  30 days

Secondary Outcomes (1)

• Evaluation of pharmacokinetics of ravulizumab in participants with COVID-19

  120 days

Study Arms (2)

Interventional arm

EXPERIMENTAL

ravulizumab

Drug: Ravulizumab

Control arm

NO INTERVENTION

patients in this arm will recieve standard care

Interventions

Ravulizumab DRUG

Patients will receive weight-based dosing of ravulizumab on Days 1, 5, 10, and 15 along with the standard care.

Interventional arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or Females 18 years of age or above and weighing 40kg or above at the time of providing informed consent.
• 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.
• Diagnosis of SARS-CoV-2 infection within 90 days prior to enrollment

You may not qualify if:

• Participant is not expected to survive more than 24 hours.
• Participant has an unresolved Neisseria Meningitides infection.
• Hypersensitivity to murine proteins or to one of the excipients of ravulizumab.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

COVID-19; Thrombotic Microangiopathies; Acute Kidney Injury

Interventions

ravulizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asistant professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: September 30, 2020
• Study Start: December 18, 2020
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

US (1)