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MP1032 Treatment in Patients With Moderate to Severe COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MP1032
Placebo
Sponsored by
MetrioPharm AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, MP1032

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Snake River Research PLLC
  • Richmond University Medical Center
  • MHAT Blagoevgrad AD
  • MHAT Sv. Ivan Rilski Kozloduy
  • MHAT Dr. Stamen Iliev AD
  • SHATPD Pernik EOOD
  • MHAT Dr. Ivan Seliminski AD
  • Umhatem"N.I.Pirogov"
  • SHATPPD Sata Zagora EOOD
  • Centre Hospitalier Victor Dupouy
  • CHU de Grenoble Alpes
  • Centre Hospitalier Lyon Sud
  • DE KK Infektológiai Klinika
  • Flor Ferenc Hospital of Pest County
  • Ospedale GB Morgagni
  • Ospedale SM Goretti
  • IRCCS Ospedale San Raffaele
  • ASST-FBF-SACCO - Ospedale Luigi Sacco
  • Policlinico di Napoli
  • Ospedale "Santo Spirito! Pescara
  • Policlinico Agostino Gemelli
  • Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
  • Spitalul Municipal Caracal
  • Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"
  • Clinica Anestezie si Terapie Intensiva
  • Hospital Clinic de Barcelona Hospital Clinic i Provincial
  • Hospital Ramon y Cajal, Edificio Central
  • Hospital Clínico Universitario de Salamanca
  • Hospital Universitario Marqués de Valdecilla/IDIVAL
  • Hospital Universitario de Valme
  • Hospital Álvaro Cunqueiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MP1032

Placebo

Arm Description

Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days.

Participants will receive placebo matched to MP1032 with hospital selected SoC for 28 days.

Outcomes

Primary Outcome Measures

Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation 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 - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Secondary Outcome Measures

Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28
Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Percentage of Participants With Disease Resolution at Day 28
Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
All-cause Mortality Rate up to Day 28
All-cause mortality rate was the percentage of participants in each treatment group who died by Day 28 were reported.
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale was 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. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Percentage of Participants With Disease Resolution at Day 14
Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
All-cause Mortality Rate up to Day 14 and Day 60
The percentage of participants who died by Day 14 and Day 60 were reported.
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14
The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score related to COVID-19 at Day 14 were reported.
Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28
Percentage of participants who required invasive mechanical ventilation/ECMO or who died by Day 14 and Day 28 were reported.
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit
The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score at each visit were reported.
Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale
The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Participants who did not improve at least 1 category on the NIAID scale or died before Day 28 were censored at Day 28. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Percentage of Participants With Clinical Status Improvement of at Least 1 Category From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28
NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Higher score = improvement in clinical status. Percentage of Participants with Clinical Status Improvement of at least 1 category from baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 were reported.
Time to Discharge by Day 28 and Day 60
Time to discharge i.e., the total duration of participant hospitalization from baseline to discharge at Day 28 and Day 60 was reported.
Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60
Percentage of participants who were alive and tested negative for COVID-19 at Day 14, Day 28, and Day 60 were reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An Adverse Event (AE) was any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. TEAE was defined as any adverse event which starts or worsens at any time after initiation of study drug until the end of the follow-up period at Day 60. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Number of participants with TEAEs and Serious TEAEs were reported.
Number of Participants With Clinically Significant Change in Vital Sign
Vital sign parameters included of systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature. Any clinically significant change in vital signs were judged by the investigator. Number of participants with clinically significant change in vital sign values were reported.
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
Physical examination included examination of respiratory, cardiovascular, dermatological, neurological, and gastrointestinal system. Any clinically significant abnormalities in physical examination were judged by the investigator. Number of participants with clinically significant abnormalities in physical examinations findings were reported.
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results
Clinical laboratory tests included biochemistry, hematology and urinalysis. Any clinically significant abnormalities in clinical laboratory results were judged by the investigator. Number of participants with clinically significant abnormalities in laboratory results were reported.
Maximum Observed Plasma Concentration (Cmax) of MP1032
Cmax of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032
AUC0-t of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Apparent Elimination Rate Constant (Kel) of MP1032
Kel was calculated using negative of the estimated slope of the linear regression of the ln-transformed plasma concentration versus time profile in the terminal elimination phase. Kel of MP1032 in plasma were reported.
Apparent Body Clearance (CL/F) of MP1032
Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported.
Apparent Volume of Distribution (Vz/F) of MP1032
Vz/F was estimated as Dose/(Kel x AUC0-inf). Vz/F of MP1032 in plasma was reported.
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032
Ctrough of MP1032 in plasma was reported.
Average Observed Plasma Concentration at Steady State of MP1032
Average observed plasma concentration at steady state of MP1032 was reported.

Full Information

First Posted
June 18, 2021
Last Updated
June 12, 2023
Sponsor
MetrioPharm AG
Collaborators
Syneos Health, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04932941
Brief Title
MP1032 Treatment in Patients With Moderate to Severe COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MetrioPharm AG
Collaborators
Syneos Health, LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, MP1032

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP1032
Arm Type
Experimental
Arm Description
Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to MP1032 with hospital selected SoC for 28 days.
Intervention Type
Drug
Intervention Name(s)
MP1032
Intervention Description
Hard gelatin capsules for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules matched to MP1032 for oral administration.
Primary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
Description
Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation 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 - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Time Frame
At Day 14
Secondary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28
Description
Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Time Frame
At Day 28
Title
Percentage of Participants With Disease Resolution at Day 28
Description
Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Time Frame
At Day 28
Title
All-cause Mortality Rate up to Day 28
Description
All-cause mortality rate was the percentage of participants in each treatment group who died by Day 28 were reported.
Time Frame
Up to Day 28
Title
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28
Description
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale was 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. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Time Frame
Baseline, Day 28
Title
Percentage of Participants With Disease Resolution at Day 14
Description
Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Time Frame
At Day 14
Title
All-cause Mortality Rate up to Day 14 and Day 60
Description
The percentage of participants who died by Day 14 and Day 60 were reported.
Time Frame
Up to Day 14 and Day 60
Title
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14
Description
The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score related to COVID-19 at Day 14 were reported.
Time Frame
Baseline, Day 14
Title
Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28
Description
Percentage of participants who required invasive mechanical ventilation/ECMO or who died by Day 14 and Day 28 were reported.
Time Frame
At Day 14 and Day 28
Title
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit
Description
The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score at each visit were reported.
Time Frame
Baseline up to Day 60
Title
Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale
Description
The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Participants who did not improve at least 1 category on the NIAID scale or died before Day 28 were censored at Day 28. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
Time Frame
Baseline up to Day 28
Title
Percentage of Participants With Clinical Status Improvement of at Least 1 Category From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28
Description
NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Higher score = improvement in clinical status. Percentage of Participants with Clinical Status Improvement of at least 1 category from baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 were reported.
Time Frame
Baseline, Day 14 and Day 28
Title
Time to Discharge by Day 28 and Day 60
Description
Time to discharge i.e., the total duration of participant hospitalization from baseline to discharge at Day 28 and Day 60 was reported.
Time Frame
Baseline, Day 28 and Day 60
Title
Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60
Description
Percentage of participants who were alive and tested negative for COVID-19 at Day 14, Day 28, and Day 60 were reported.
Time Frame
At Day 14, Day 28 and Day 60
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
An Adverse Event (AE) was any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. TEAE was defined as any adverse event which starts or worsens at any time after initiation of study drug until the end of the follow-up period at Day 60. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Number of participants with TEAEs and Serious TEAEs were reported.
Time Frame
Day 1 up to Day 60
Title
Number of Participants With Clinically Significant Change in Vital Sign
Description
Vital sign parameters included of systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature. Any clinically significant change in vital signs were judged by the investigator. Number of participants with clinically significant change in vital sign values were reported.
Time Frame
Day 1 up to Day 60
Title
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
Description
Physical examination included examination of respiratory, cardiovascular, dermatological, neurological, and gastrointestinal system. Any clinically significant abnormalities in physical examination were judged by the investigator. Number of participants with clinically significant abnormalities in physical examinations findings were reported.
Time Frame
Baseline up to Day 60
Title
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results
Description
Clinical laboratory tests included biochemistry, hematology and urinalysis. Any clinically significant abnormalities in clinical laboratory results were judged by the investigator. Number of participants with clinically significant abnormalities in laboratory results were reported.
Time Frame
Baseline up to Day 60
Title
Maximum Observed Plasma Concentration (Cmax) of MP1032
Description
Cmax of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time Frame
Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Title
Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032
Description
AUC0-t of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time Frame
Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Title
Apparent Elimination Rate Constant (Kel) of MP1032
Description
Kel was calculated using negative of the estimated slope of the linear regression of the ln-transformed plasma concentration versus time profile in the terminal elimination phase. Kel of MP1032 in plasma were reported.
Time Frame
Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Title
Apparent Body Clearance (CL/F) of MP1032
Description
Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported.
Time Frame
Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Title
Apparent Volume of Distribution (Vz/F) of MP1032
Description
Vz/F was estimated as Dose/(Kel x AUC0-inf). Vz/F of MP1032 in plasma was reported.
Time Frame
Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Title
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032
Description
Ctrough of MP1032 in plasma was reported.
Time Frame
Pre-dose concentration (Day 2, Day 7, and Day 8).
Title
Average Observed Plasma Concentration at Steady State of MP1032
Description
Average observed plasma concentration at steady state of MP1032 was reported.
Time Frame
Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Snake River Research PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
MHAT Blagoevgrad AD
City
Blagoevgrad
Country
Bulgaria
Facility Name
MHAT Sv. Ivan Rilski Kozloduy
City
Kozloduy
Country
Bulgaria
Facility Name
MHAT Dr. Stamen Iliev AD
City
Montana
Country
Bulgaria
Facility Name
SHATPD Pernik EOOD
City
Pernik
Country
Bulgaria
Facility Name
MHAT Dr. Ivan Seliminski AD
City
Sliven
Country
Bulgaria
Facility Name
Umhatem"N.I.Pirogov"
City
Sofia
Country
Bulgaria
Facility Name
SHATPPD Sata Zagora EOOD
City
Stara Zagora
Country
Bulgaria
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
Country
France
Facility Name
CHU de Grenoble Alpes
City
Grenoble Cedex 9
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Benite CEDEX
Country
France
Facility Name
DE KK Infektológiai Klinika
City
Debrecen
Country
Hungary
Facility Name
Flor Ferenc Hospital of Pest County
City
Kistarcsa
Country
Hungary
Facility Name
Ospedale GB Morgagni
City
Forlì
Country
Italy
Facility Name
Ospedale SM Goretti
City
Latina
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
ASST-FBF-SACCO - Ospedale Luigi Sacco
City
Milan
Country
Italy
Facility Name
Policlinico di Napoli
City
Napoli
Country
Italy
Facility Name
Ospedale "Santo Spirito! Pescara
City
Pescara
Country
Italy
Facility Name
Policlinico Agostino Gemelli
City
Roma
Country
Italy
Facility Name
Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
City
Bucharest
Country
Romania
Facility Name
Spitalul Municipal Caracal
City
Caracal
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"
City
Iaşi
Country
Romania
Facility Name
Clinica Anestezie si Terapie Intensiva
City
Timişoara
Country
Romania
Facility Name
Hospital Clinic de Barcelona Hospital Clinic i Provincial
City
Barcelona
Country
Spain
Facility Name
Hospital Ramon y Cajal, Edificio Central
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla/IDIVAL
City
Santander
Country
Spain
Facility Name
Hospital Universitario de Valme
City
Sevilla
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MP1032 Treatment in Patients With Moderate to Severe COVID-19

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