Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation

NCT04492514 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IND 149353
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

Conditions

COVID 19; SARS-CoV 2; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Alive and Off Oxygen at 14 Days

  Number of subjects alive and off of oxygen

  14 days

Secondary Outcomes (1)

• Proportion of Subjects Alive and Without Respiratory Failure at 28 Days

  28 days

Study Arms (2)

Mavrilimumab

EXPERIMENTAL

Mavrilimumab Treatment infusion

Drug: Mavrilimumab

Placebo

PLACEBO COMPARATOR

Placebo infusion

Drug: Placebo

Interventions

Mavrilimumab DRUG

Treatment infusion

Also known as: KPL-301

Mavrilimumab

Placebo DRUG

Placebo infusion

Also known as: Control

Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained before any assessment is performed
• Documented COVID19 pneumonia defined as positive SARS-CoV2 test AND abnormalities/ infiltrates on chest x-ray or computed tomography AND active fever or documented fever within 24-48 hours or ongoing anti-pyretic use to suppress fever
• Hypoxia (Room air SpO2 \<92% or requirement for supplemental oxygen)
• Increased serum inflammatory marker (CRP \> 5 mg/dL)
• Severity of disease warrants inpatient hospitalization

You may not qualify if:

• Onset of COVID-19 symptoms \>14 days
• Age \< 18 years-old
• Hospitalized \>7 days
• Mechanically ventilated
• Serious concomitant illness which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):
• History of immunodeficiency (congenital or acquired)
• Neutropenia (absolute neutrophil count \<1,500/mm3)
• History of solid-organ or bone marrow transplant
• History of current systemic autoimmune or autoinflammatory disease(s) requiring systemic immune-modulating drugs
• History of myeloproliferative disorder or active malignancy receiving cytotoxic chemotherapy
• Pre-existing severe pulmonary disease (i.e. steroid dependent asthma, COPD on home oxygen, or other restrictive/obstructive lung disease requiring home oxygen)
• Pre-existing severe left ventricular systolic dysfunction (i.e. LVEF \<35%)
• Known or suspected active tuberculosis (TB), latent TB, or history of incompletely treated TB or at high risk for latent TB (from exposure or prior incarceration)
• History of active or latent viral hepatitis (i.e. Hepatitis B or C)
• Concomitant uncontrolled systemic bacterial or fungal infection

Sponsors & Collaborators

• Kristin Hudock: lead
• Kiniksa Pharmaceuticals, Ltd.: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• Cremer PC, Abbate A, Hudock K, McWilliams C, Mehta J, Chang SY, Sheng CC, Van Tassell B, Bonaventura A, Vecchie A, Carey B, Wang Q, Wolski KE, Rajendram P, Duggal A, Wang TS, Paolini JF, Trapnell BC; MASH-COVID study group. Mavrilimumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation (MASH-COVID): an investigator initiated, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Rheumatol. 2021 Jun;3(6):e410-e418. doi: 10.1016/S2665-9913(21)00070-9. Epub 2021 Mar 17.

  PMID: 33754144 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

mavrilimumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Research Director
• Organization: University of Cincinnati

mcmahasn@ucmail.uc.edu

513-584-0156

Study Officials

• Kristin Hudock, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Pediatrics

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: May 20, 2020
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)