Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inflammatory Signal Inhibitors for COVID-19 (MATIS) (MATIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581954
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
Rigel Pharmaceuticals
Novartis
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.

Condition or disease Intervention/treatment Phase
Coronavirus Covid19 Pneumonia Drug: Ruxolitinib Drug: Fostamatinib Other: Standard of care Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Multi-arm Trial of Ruxolitinib (RUX) and Fostamatinib (FOS) for COVID-19 Pneumonia
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Active Comparator: Standard of care Other: Standard of care
Standard of care treatment as per site-level policies and guidelines.

Active Comparator: Fostamatinib Drug: Fostamatinib
Fostamatinib is a tyrosine kinase inhibitor with activity against spleen tyrosine kinase (SYK). It has approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP).

Active Comparator: Ruxolitinib Drug: Ruxolitinib
Ruxolitinib is a Janus kinase 1 (JAK1)/Janus kinase 2 (JAK2) inhibitor approved for clinical use in the treatment of splenomegaly, myelofibrosis, polycythaemia vera and graft-versus-host disease. It is an oral agent with a rapid mode of action.




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Day 14 ]
  2. Number and proportion of patients requiring invasive ventilation [ Time Frame: Day 14 ]
  3. Number and proportion of patients requiring non-invasive ventilation (CPAP and high flow nasal oxygen) [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Day 28 ]
  2. Number and proportion of patients requiring invasive ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: Day 14, 28 ]
  3. Number and proportion of patients requiring non-invasive ventilation including continuous positive airway pressure (CPAP) or high flow nasal oxygen [ Time Frame: Day 14, 28 ]
  4. Number and proportion of patients requiring renal replacement therapy [ Time Frame: Day 14, 28 ]
  5. Number and proportion of patients experiencing venous thromboembolism events [ Time Frame: Day 14, 28 ]
  6. Length of stay [ Time Frame: Day 14, 28 ]
  7. Number and proportion of serious adverse events and discontinuations [ Time Frame: Day 14, 28 ]
  8. Absolute change in pneumonia severity on the modified WHO COVID-19 Ordinal Scale [ Time Frame: Day 14, 28 ]
    Scale range from 0 (uninfected) to 9 (dead)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age ≥ 18 years at screening
  • Patients with mild or moderate C19 pneumonia, defined as Grade 3 or 4 severity by the WHO COVID-19 Ordinal Scale by
  • Patients meeting criteria: Hospitalization AND SARS-CoV2 infection (clinically suspected* or laboratory confirmed) AND Radiological change consistent with COVID-19 disease
  • C-reactive protein (CRP) greater than or equal to 50mg/L
  • Informed consent from patient or personal or professional representative
  • No medical history that might, in the opinion of the responsible clinician, put the patient at significant risk if he/she were to participate in the trial
  • Agreement to abstain from sexual intercourse or use contraception that is >99% effective for all participants of childbearing potential for 42 days after the last dose of study drug. For male participants, agreement to abstain from sperm donation for 42 days after the last dose of study drug.
  • Able to read English. Non-English speakers will be able to join the study. If patients are unable to understand verbal or written information in English - hospital translation services will be requested at the participating site for the participant where possible.

Exclusion Criteria:

  • Requiring either invasive or non-invasive ventilation including CPAP or high flow nasal oxygen at any point before baseline
  • Grade greater than or equal to 5 severity on the modified WHO COVID-19 Ordinal Scale, viz. O2 saturation < 90% on greater than or equal to 60% inspired oxygen at baseline; non-invasive ventilation; or invasive mechanical ventilation
  • In the opinion of the investigator, progression to death is inevitable within the next 24 hours, irrespective of the provision of therapy
  • Known severe allergic reactions to the investigational agents
  • Child Pugh B or C grade hepatic dysfunction
  • End Stage Renal Failure
  • Use of drugs within the preceding 14 days that are known to interact with any study treatment (FOS or RUX), as listed in the Summary of Product Characteristics
  • Pregnant or breast feeding
  • Any medical condition or concomitant medication that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures.
  • Any medical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581954


Contacts
Layout table for location contacts
Contact: Nichola Cooper +44 (0)20 3313 1175 n.cooper@imperial.ac.uk
Contact: Clio Pillay +44 (0)7778552277 clio.pillay@nhs.net

Locations
Layout table for location information
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Melanie T Almonte    +44 (0)7778552277    melanie.almonte@nhs.net   
Principal Investigator: Nichola Cooper         
Principal Investigator: Nikhil Vergis         
Principal Investigator: Richard Turner         
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Rigel Pharmaceuticals
Novartis
Investigators
Layout table for investigator information
Principal Investigator: Nichola Cooper Imperial College London
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04581954    
Other Study ID Numbers: 20HH5926
2020-001750-22 ( EudraCT Number )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be determined

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
coronavirus
covid19
pneumonia
ruxolitinib
fostamatinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases