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MP1032 Treatment in Patients With Moderate to Severe COVID-19

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: NCT04932941
Recruitment Status : Recruiting
First Posted : June 21, 2021
Last Update Posted : February 2, 2022
Sponsor:
Collaborator:
Syneos Health, LLC
Information provided by (Responsible Party):
MetrioPharm AG

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe coronavirus disease 2019 (COVID-19).

Condition or disease Intervention/treatment Phase
COVID-19 Drug: MP1032 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept, Phase IIA Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Participants With Moderate to Severe COVID-19
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MP1032
Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days.
Drug: MP1032
Hard gelatin capsules for oral administration.

Placebo Comparator: Placebo
Participants will receive placebo matched to MP1032 with hospital selected SoC for 28 days.
Drug: Placebo
Placebo capsules matched to MP1032 for oral administration.




Primary Outcome Measures :
  1. Percentage of Participants with Disease Progression at Day 14 [ Time Frame: Day 14 ]

    The National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale is an assessment of clinical status on a given study day and is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or extracorporeal membrane oxygenation [ECMO])
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

    Disease progression defined as participants who are not alive or who have respiratory failure (participants who have a score of 2, 3, or 4 on the NIAID scale).



Secondary Outcome Measures :
  1. Percentage of Participants with Disease Progression at Day 28 [ Time Frame: Day 28 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

    Disease progression is defined as participants who are not alive or who have respiratory failure (participants who have a score of 2, 3, or 4 on the NIAID 8-point ordinal scale).


  2. Percentage of Participants with Disease Resolution at Day 28 [ Time Frame: Day 28 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

    Disease resolution is defined as participants who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale.


  3. All-cause Mortality Rate at Day 28 [ Time Frame: Day 28 ]
  4. Change from Baseline in Clinical Status related to COVID-19 according to the NIAID 8-point Ordinal Scale at Day 28 [ Time Frame: Baseline, Day 28 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

  5. Percentage of Participants with Disease Resolution at Day 14 [ Time Frame: Day 14 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

    Disease resolution is defined as participants who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale.


  6. All-cause Mortality Rate at Day 14 and Day 60 [ Time Frame: Day 14 and Day 60 ]
  7. Change from Baseline in Clinical Status related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14 [ Time Frame: Baseline, Day 14 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

  8. Percentage of Participants requiring Invasive Ventilation (Mechanical Ventilator and/or ECMO), or who are not Alive on Day 14 and Day 28 [ Time Frame: Day 14 and Day 28 ]
  9. Percentage of Participants in each category of the NIAID 8-point Ordinal Scale [ Time Frame: From Baseline up to Day 60 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

  10. Time to (First) Improvement of at least 1 Category on the NIAID 8-point Ordinal Scale [ Time Frame: From Baseline up to Day 28 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

  11. The Odds Ratio for the Number of Participants with Clinical Status Improvement From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 [ Time Frame: Baseline, Day 14 and Day 28 ]

    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows; where higher score indicates improvement in the clinical status:

    1. Death
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO)
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons)
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen
    8. Not hospitalized, no limitations on activities

  12. Total Duration of Hospitalization at Day 28 and Day 60 [ Time Frame: From Baseline, Day 28 and Day 60 ]
  13. Percentage of Participants alive and testing negative for COVID-19 at Day 14, Day 28, and Day 60 [ Time Frame: Day 14, Day 28 and Day 60 ]
  14. Number of Participants with treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 60 ]
  15. Number of Participants with Vital Sign Abnormalities [ Time Frame: Day 1 up to Day 60 ]
    Systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature) abnormalities will be reported.

  16. Number of Participants With Physical Examination Findings [ Time Frame: Day 1 up to Day 60 ]
  17. Number of Participants with Laboratory Findings [ Time Frame: Day 1 up to Day 60 ]
    Abnormalities in haematology, coagulation, clinical chemistry, serum inflammatory, and urinalysis abnormalities will be reported.

  18. Maximum Observed Plasma Concentration (Cmax) of MP1032 [ Time Frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 ]
  19. Area Under the Plasma Concentration-time curve from Time Zero (pre-dose) to last non-zero concentration (AUC0-t) of MP1032 [ Time Frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 ]
  20. Apparent Elimination Rate Constant (K) of MP1032 [ Time Frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 ]
  21. Apparent Body Clearance (CL) of MP1032 [ Time Frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 ]
  22. Apparent Volume of Distribution (Vd) of MP1032 [ Time Frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 ]
  23. Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 [ Time Frame: Pre-dose at Day 1 and Day 7 ]
  24. Average Observed Plasma Concentration at Steady State of MP1032 [ Time Frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 7 ]


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.


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

Key Inclusion Criteria:

  • Participant is admitted to hospital and has a positive severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) test by standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test
  • Participant has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19

Key Exclusion Criteria:

  • Participant, in opinion of the investigator, is not likely to survive >=48 hours beyond Day 1
  • Participant has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1
  • Participant has a documented medical history of infection with hepatitis A, B, C, or with human immunodeficiency virus (with a detectable viral load and CD4 count <500 cells per micro liter), or a documented active infection with tuberculosis.
  • The Participant has clinically significant electrocardiogram (ECG) abnormalities at screening

Other protocol defined inclusion/exclusion criteria may apply


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): NCT04932941


Contacts
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Contact: Eline Van Dijk-Stam +31621176377 eline.vandijkstam@syneoshealth.com
Contact: Anna Abramenkova anna.abramenkova@syneoshealth.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
MetrioPharm AG
Syneos Health, LLC
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Responsible Party: MetrioPharm AG
ClinicalTrials.gov Identifier: NCT04932941    
Other Study ID Numbers: MP1032-CT05
2021-000344-21 ( EudraCT Number )
First Posted: June 21, 2021    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MetrioPharm AG:
COVID-19
MP1032
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases