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

NCT04399980 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IND 149324IRB 20-523
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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)

• Subjects Alive and Off of Oxygen at Day 14

  Number and percentage of subjects alive and off of oxygen at day 14

  Day 14

Secondary Outcomes (2)

• Number of Subjects Alive and Without Respiratory Failure at Day 28

  Day 28

• Mortality at Day 28

  Day 28

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Treatment infusion

Drug: Mavrilimumab

Control

PLACEBO COMPARATOR

Placebo infusion

Drug: Placebos

Interventions

Mavrilimumab DRUG

Treatment infusion

Also known as: KPL-301

Intervention

Placebos DRUG

Placebo infusion

Also known as: Control

Control

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

• The Cleveland Clinic: lead
• Kiniksa Pharmaceuticals, Ltd.: collaborator

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Cleveland Clinic Health System

Cleveland, Ohio, 44195, 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: Paul C. Cremer, MD
• Organization: Cleveland Clinic

cremerp@ccf.org

216-444-6765

Study Officials

• Paul C Cremer, M. D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 22, 2020
• Study Start: May 20, 2020
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)