COVID-19
Conditions
Keywords
COVID-19, MP1032
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).
Interventions
DRUGMP1032
Hard gelatin capsules for oral administration.
DRUGPlacebo
Placebo capsules matched to MP1032 for oral administration.
Sponsors
Syneos Health
MetrioPharm AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Resolution at Day 28 | 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 | 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 | Baseline, 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 | 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 | 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 | Baseline, 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 | 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 | Baseline up to Day 60 | 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 | Baseline up to Day 28 | 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 | Baseline, 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 | Baseline, 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 With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28 | 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Day 1 up to Day 60 | 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 | Day 1 up to Day 60 | 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 | Baseline up to Day 60 | 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 | Baseline up to Day 60 | 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 | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 | 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 | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 | 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 | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 | 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 | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 | Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported. |
| Apparent Volume of Distribution (Vz/F) of MP1032 | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 | 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 | Pre-dose concentration (Day 2, Day 7, and Day 8). | Ctrough of MP1032 in plasma was reported. |
| Average Observed Plasma Concentration at Steady State of MP1032 | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 | Average observed plasma concentration at steady state of MP1032 was reported. |
| Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | 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. |
Countries
Bulgaria, France, Hungary, Italy, Romania, Spain, United States
Participant flow
Recruitment details
The study was conducted at 20 sites in 6 countries from 19 October 2021 to 05 September 2022. Participants were randomized in the 2:1 ratio to treatment groups using an Interactive Web Response System (IWRS).
Pre-assignment details
A total of 134 participants were screened, of which 132 participants were randomized to either the MP1032 plus standard of care (SoC) group or the placebo plus SoC group.
Participants by arm
| Arm | Count |
|---|---|
| MP1032 300mg + SoC Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | 87 |
| Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | 45 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Other | 4 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Placebo + SoC | Total | MP1032 300mg + SoC |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 14.15 | 60.5 years STANDARD_DEVIATION 13.94 | 59.6 years STANDARD_DEVIATION 13.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 123 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 132 Participants | 87 Participants |
| Sex: Female, Male Female | 19 Participants | 55 Participants | 36 Participants |
| Sex: Female, Male Male | 26 Participants | 77 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 86 | 2 / 45 |
| other Total, other adverse events | 46 / 86 | 26 / 45 |
| serious Total, serious adverse events | 5 / 86 | 3 / 45 |
Outcome results
Primary
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.
Time frame: At Day 14
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MP1032 300mg + SoC | Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 | 9.8 percentage of participants |
| Placebo + SoC | Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 | 11.6 percentage of participants |
p-value: 0.96295% CI: [-11.634, 11.081]Mantel Haenszel
Secondary
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.
Time frame: Up to Day 14 and Day 60
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MP1032 300mg + SoC | All-cause Mortality Rate up to Day 14 and Day 60 | Day 14 | 1.2 percentage of participants |
| MP1032 300mg + SoC | All-cause Mortality Rate up to Day 14 and Day 60 | Day 60 | 3.8 percentage of participants |
| Placebo + SoC | All-cause Mortality Rate up to Day 14 and Day 60 | Day 14 | 2.3 percentage of participants |
| Placebo + SoC | All-cause Mortality Rate up to Day 14 and Day 60 | Day 60 | 4.9 percentage of participants |
Secondary
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.
Time frame: Up to Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MP1032 300mg + SoC | All-cause Mortality Rate up to Day 28 | 2.4 percentage of participants |
| Placebo + SoC | All-cause Mortality Rate up to Day 28 | 2.4 percentage of participants |
Secondary
Apparent Body Clearance (CL/F) of MP1032
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
Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MP1032 300mg + SoC | Apparent Body Clearance (CL/F) of MP1032 | 625.05 liter per hour (l/h) | Geometric Coefficient of Variation 26.09 |
Secondary
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.
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MP1032 300mg + SoC | Apparent Elimination Rate Constant (Kel) of MP1032 | 0.7162 Per hour (1/h) | Standard Deviation 0.8851 |
Secondary
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.
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MP1032 300mg + SoC | Apparent Volume of Distribution (Vz/F) of MP1032 | 1494.56 liter | Geometric Coefficient of Variation 130.81 |
Secondary
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.
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, number analyzed signifies participants who were evaluable at a specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MP1032 300mg + SoC | Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 | Day 1 | 350.40 hour*nanograms per millilitre (h*ng/mL) | Geometric Coefficient of Variation 42.87 |
| MP1032 300mg + SoC | Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 | Day 7 | 251.24 hour*nanograms per millilitre (h*ng/mL) | Geometric Coefficient of Variation 28.72 |
Secondary
Average Observed Plasma Concentration at Steady State of MP1032
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
Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, number analyzed signifies participants who were evaluable at a specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: pre-dose | 0 ng/ml | Geometric Coefficient of Variation 0 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 0.16 hours post-dose | 175.7 ng/ml | Geometric Coefficient of Variation 322.8 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 0.33 hours post-dose | 200.1 ng/ml | Geometric Coefficient of Variation 84.6 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 0.5 hours post-dose | 140.4 ng/ml | Geometric Coefficient of Variation 55.3 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 1 hour post-dose | 64.39 ng/ml | Geometric Coefficient of Variation 34.5 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 2 hours post-dose | 28.55 ng/ml | Geometric Coefficient of Variation 145.5 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 8 hours post-dose | 15.48 ng/ml | Geometric Coefficient of Variation 29.7 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 1: 24 hours post-dose | 19.45 ng/ml | Geometric Coefficient of Variation 7.5 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: pre-dose | 243.2 ng/ml | Geometric Coefficient of Variation 0 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 0.16 hours post-dose | 187.3 ng/ml | Geometric Coefficient of Variation 53.3 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 0.33 hours post-dose | 281.5 ng/ml | Geometric Coefficient of Variation 55.4 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 0.5 hours post-dose | 178.8 ng/ml | Geometric Coefficient of Variation 41.1 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 1 hour post-dose | 94.42 ng/ml | Geometric Coefficient of Variation 117.8 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 2 hours post-dose | 79.55 ng/ml | Geometric Coefficient of Variation 155 |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 8 hours post-dose | NA ng/ml | — |
| MP1032 300mg + SoC | Average Observed Plasma Concentration at Steady State of MP1032 | Day 7: 24hours post-dose | 200.0 ng/ml | Geometric Coefficient of Variation 0 |
Secondary
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 frame: Baseline up to Day 60
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 9 | 2.0 score on a scale | Standard Deviation 1.7 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 28 | 3.7 score on a scale | Standard Deviation 0.89 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 10 | 2.2 score on a scale | Standard Deviation 1.69 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 5 | 0.4 score on a scale | Standard Deviation 0.88 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 11 | 2.3 score on a scale | Standard Deviation 1.65 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 2 | 0.1 score on a scale | Standard Deviation 0.42 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 12 | 2.5 score on a scale | Standard Deviation 1.66 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 6 | 0.6 score on a scale | Standard Deviation 1.01 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 13 | 2.7 score on a scale | Standard Deviation 1.64 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 3 | 0.2 score on a scale | Standard Deviation 0.73 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 14 | 3.0 score on a scale | Standard Deviation 1.47 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 7 | 1.2 score on a scale | Standard Deviation 1.44 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 4 | 0.2 score on a scale | Standard Deviation 0.83 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 60 | 3.7 score on a scale | Standard Deviation 1.01 |
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 8 | 1.6 score on a scale | Standard Deviation 1.6 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 60 | 3.8 score on a scale | Standard Deviation 0.49 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 8 | 1.6 score on a scale | Standard Deviation 1.75 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 3 | 0.1 score on a scale | Standard Deviation 0.46 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 4 | 0.2 score on a scale | Standard Deviation 0.53 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 5 | 0.3 score on a scale | Standard Deviation 0.7 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 6 | 0.4 score on a scale | Standard Deviation 0.76 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 7 | 1.0 score on a scale | Standard Deviation 1.34 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 9 | 1.7 score on a scale | Standard Deviation 1.77 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 10 | 1.7 score on a scale | Standard Deviation 1.83 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 11 | 1.9 score on a scale | Standard Deviation 1.82 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 12 | 1.9 score on a scale | Standard Deviation 1.82 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 13 | 2.2 score on a scale | Standard Deviation 1.71 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 14 | 2.6 score on a scale | Standard Deviation 1.72 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 28 | 3.7 score on a scale | Standard Deviation 0.51 |
| Placebo + SoC | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | Day 2 | 0.0 score on a scale | Standard Deviation 0.21 |
Secondary
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.
Time frame: Baseline, Day 14
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14 | 2.987 score on a scale | Standard Error 0.174 |
| Placebo + SoC | Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14 | 2.543 score on a scale | Standard Error 0.242 |
Secondary
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.
Time frame: Baseline, Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MP1032 300mg + SoC | Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28 | 3.542 score on a scale | Standard Error 0.13 |
| Placebo + SoC | Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28 | 3.612 score on a scale | Standard Error 0.174 |
Secondary
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.
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Population: The Pharmacokinetic (PK) Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, number analyzed signifies participants who were evaluable at a specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MP1032 300mg + SoC | Maximum Observed Plasma Concentration (Cmax) of MP1032 | Day 1 | 284.15 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 170.38 |
| MP1032 300mg + SoC | Maximum Observed Plasma Concentration (Cmax) of MP1032 | Day 7 | 279.29 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 37.85 |
Secondary
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.
Time frame: Baseline up to Day 60
Population: The Safety Set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results | 23 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results | 22 Participants |
Secondary
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.
Time frame: Baseline up to Day 60
Population: The Safety Set included all randomized participants who received at least 1 dose of study drug. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Head, Eyes, Ears, Nose, and Throat- Day 8 | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Cardiovascular-Day 8 | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Neurologic- Day 14 | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Abdomen- Baseline | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Other- Baseline | 14 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Other- Day 8 | 1 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Neurologic- Baseline | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Other- Day 14 | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Cardiovascular-Day 14 | 2 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Respiratory- Baseline | 38 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Abdomen- Day 8 | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Respiratory- Day 8 | 4 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Head, Eyes, Ears, Nose, and Throat- Baseline | 8 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Respiratory- Day 14 | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Cardiovascular- Baseline | 4 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Dermatologic- Baseline | 0 Participants |
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Head, Eyes, Ears, Nose, and Throat- Day 14 | 0 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Dermatologic- Baseline | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Head, Eyes, Ears, Nose, and Throat- Baseline | 7 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Other- Baseline | 8 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Abdomen- Day 8 | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Cardiovascular- Baseline | 2 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Cardiovascular-Day 8 | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Cardiovascular-Day 14 | 0 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Head, Eyes, Ears, Nose, and Throat- Day 8 | 2 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Head, Eyes, Ears, Nose, and Throat- Day 14 | 2 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Neurologic- Baseline | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Neurologic- Day 14 | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Other- Day 8 | 2 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Other- Day 14 | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Respiratory- Baseline | 22 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Respiratory- Day 8 | 2 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Respiratory- Day 14 | 1 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Body System: Abdomen- Baseline | 1 Participants |
Secondary
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.
Time frame: Day 1 up to Day 60
Population: The Safety Set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MP1032 300mg + SoC | Number of Participants With Clinically Significant Change in Vital Sign | 0 Participants |
| Placebo + SoC | Number of Participants With Clinically Significant Change in Vital Sign | 0 Participants |
Secondary
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.
Time frame: Day 1 up to Day 60
Population: The Safety Set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MP1032 300mg + SoC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with TEAEs | 46 Participants |
| MP1032 300mg + SoC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with Serious TEAEs | 5 Participants |
| Placebo + SoC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with TEAEs | 26 Participants |
| Placebo + SoC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Participants with Serious TEAEs | 3 Participants |
Secondary
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.
Time frame: At Day 14 and Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MP1032 300mg + SoC | Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 | Day 14 | 1.2 percentage of participants |
| MP1032 300mg + SoC | Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 | Day 28 | 2.5 percentage of participants |
| Placebo + SoC | Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 | Day 14 | 2.3 percentage of participants |
| Placebo + SoC | Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 | Day 28 | 2.4 percentage of participants |
Secondary
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.
Time frame: At Day 14, Day 28 and Day 60
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MP1032 300mg + SoC | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Day 14 | 67.1 percentage of participants |
| MP1032 300mg + SoC | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Day 28 | 91.3 percentage of participants |
| MP1032 300mg + SoC | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Day 60 | 95.5 percentage of participants |
| Placebo + SoC | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Day 14 | 66.7 percentage of participants |
| Placebo + SoC | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Day 28 | 92.1 percentage of participants |
| Placebo + SoC | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Day 60 | 93.5 percentage of participants |
Secondary
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 frame: Baseline, Day 14 and Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Number Analyzed signifies participants for whom NIAID data were available for Day 14 and Day 28, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MP1032 300mg + SoC | 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 | Day 14 | 90.2 percentage of participants |
| MP1032 300mg + SoC | 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 | Day 28 | 98.7 percentage of participants |
| Placebo + SoC | 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 | Day 14 | 86.0 percentage of participants |
| Placebo + SoC | 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 | Day 28 | 100 percentage of participants |
Secondary
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.
Time frame: At Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MP1032 300mg + SoC | Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28 | 2.5 percentage of participants |
| Placebo + SoC | Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28 | 2.4 percentage of participants |
Secondary
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.
Time frame: At Day 14
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MP1032 300mg + SoC | Percentage of Participants With Disease Resolution at Day 14 | 84.1 percentage of participants |
| Placebo + SoC | Percentage of Participants With Disease Resolution at Day 14 | 72.1 percentage of participants |
Secondary
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.
Time frame: At Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MP1032 300mg + SoC | Percentage of Participants With Disease Resolution at Day 28 | 97.5 percentage of participants |
| Placebo + SoC | Percentage of Participants With Disease Resolution at Day 28 | 97.6 percentage of participants |
Secondary
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032
Ctrough of MP1032 in plasma was reported.
Time frame: Pre-dose concentration (Day 2, Day 7, and Day 8).
Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MP1032 300mg + SoC | Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 | Day 7 | 60.79 ng/ml | Standard Deviation 121.59 |
| MP1032 300mg + SoC | Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 | Day 2 | 9.74 ng/ml | Standard Deviation 11.27 |
| MP1032 300mg + SoC | Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 | Day 8 | 66.67 ng/ml | Standard Deviation 115.48 |
Secondary
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.
Time frame: Baseline, Day 28 and Day 60
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MP1032 300mg + SoC | Time to Discharge by Day 28 and Day 60 | Day 28 | 9 days |
| MP1032 300mg + SoC | Time to Discharge by Day 28 and Day 60 | Day 60 | 9 days |
| Placebo + SoC | Time to Discharge by Day 28 and Day 60 | Day 28 | 10 days |
| Placebo + SoC | Time to Discharge by Day 28 and Day 60 | Day 60 | 10 days |
Secondary
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.
Time frame: Baseline up to Day 28
Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. As the table refers to time to improvement', here, Overall Number of Participants Analyzed only signifies participants with at least 1 NIAID category of improvement at any time up to Day 28.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MP1032 300mg + SoC | Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale | 7 days |
| Placebo + SoC | Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale | 7 days |