Phase 2
N=132
MP1032 Treatment in Patients With Moderate to Severe COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04932941 ↗Enrolled (actual)
132
Serious AEs
6.1%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 — 9.8; 11.6 percentage of participants — p=0.962
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MP1032 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MetrioPharm AG
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 |
9.8; 11.6 | 0.962 |
| SECONDARY Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28 |
2.5; 2.4 | — |
| SECONDARY Percentage of Participants With Disease Resolution at Day 28 |
97.5; 97.6 | — |
| SECONDARY All-cause Mortality Rate up to Day 28 |
2.4; 2.4 | — |
| SECONDARY Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28 |
3.542; 3.612 | — |
| SECONDARY Percentage of Participants With Disease Resolution at Day 14 |
84.1; 72.1 | — |
| SECONDARY All-cause Mortality Rate up to Day 14 and Day 60 |
1.2; 2.3; 3.8; 4.9 | — |
| SECONDARY Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14 |
2.987; 2.543 | — |
| SECONDARY Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 |
1.2; 2.3; 2.5; 2.4 | — |
| SECONDARY Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit |
0.1; 0.0; 0.2; 0.1; 0.2; 0.2 | — |
| SECONDARY Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale |
7; 7 | — |
| 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 |
90.2; 86.0; 98.7; 100 | — |
| SECONDARY Time to Discharge by Day 28 and Day 60 |
9; 10; 9; 10 | — |
| SECONDARY Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 |
67.1; 66.7; 91.3; 92.1; 95.5; 93.5 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
46; 26; 5; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Vital Sign |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Physical Examinations |
0; 1; 0; 1; 4; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results |
23; 22 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of MP1032 |
284.15; 279.29 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 |
350.40; 251.24 | — |
| SECONDARY Apparent Elimination Rate Constant (Kel) of MP1032 |
0.7162 | — |
| SECONDARY Apparent Body Clearance (CL/F) of MP1032 |
625.05 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of MP1032 |
1494.56 | — |
| SECONDARY Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 |
9.74; 60.79; 66.67 | — |
| SECONDARY Average Observed Plasma Concentration at Steady State of MP1032 |
0; 175.7; 200.1; 140.4; 64.39; 28.55 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04932941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.