COVID-19Phase 2NCT04932941
MP1032 Treatment in Patients With Moderate to Severe COVID-19
A Phase 2 study testing MP1032 in people with COVID-19, run by MetrioPharm AG at 31 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- MP1032
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 19 Oct 2021to 5 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
Bulgaria7 sites
MHAT Blagoevgrad AD
Blagoevgrad
MHAT Sv. Ivan Rilski Kozloduy
Kozloduy
MHAT Dr. Stamen Iliev AD
Montana
SHATPD Pernik EOOD
Pernik
MHAT Dr. Ivan Seliminski AD
Sliven
Umhatem"N.I.Pirogov"
Sofia
SHATPPD Sata Zagora EOOD
Stara Zagora
Italy7 sites
Ospedale GB Morgagni
Forlì
Ospedale SM Goretti
Latina
ASST-FBF-SACCO - Ospedale Luigi Sacco
Milan
IRCCS Ospedale San Raffaele
Milan
Policlinico di Napoli
Naples
Ospedale "Santo Spirito! Pescara
Pescara
Policlinico Agostino Gemelli
Roma
Spain6 sites
Hospital Clinic de Barcelona Hospital Clinic i Provincial
Barcelona
Hospital Ramon y Cajal, Edificio Central
Madrid
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Universitario Marqués de Valdecilla/IDIVAL
Santander
Hospital Universitario de Valme
Seville
Hospital Álvaro Cunqueiro
Vigo
Romania4 sites
Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
Bucharest
Spitalul Municipal Caracal
Caracal
Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"
Iași
Clinica Anestezie si Terapie Intensiva
Timișoara
France3 sites
Centre Hospitalier Victor Dupouy
Argenteuil
CHU de Grenoble Alpes
Grenoble
Centre Hospitalier Lyon Sud
Pierre-Bénite
United States2 sites
Snake River Research PLLC
Idaho Falls, Idaho, 83404
Richmond University Medical Center
Staten Island, New York, 10310
Hungary2 sites
DE KK Infektológiai Klinika
Debrecen
Flor Ferenc Hospital of Pest County
Kistarcsa
About this study
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
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).
- Conditions
- COVID-19
- Being tested
- MP1032, Placebo
- Keywords
- COVID-19, MP1032
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP1032Drug
Hard gelatin capsules for oral administration.
PlaceboDrug
Placebo capsules matched to MP1032 for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| MP1032 | Experimental | Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days. Receives: Drug: MP1032 |
| Placebo | Placebo comparator | Participants will receive placebo matched to MP1032 with hospital selected SoC for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 14
Secondary outcomes (24)
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.
Measured: At Day 28
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.
Measured: At Day 28
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.
Measured: Up to Day 28
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.
Measured: Baseline, Day 28
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.
Measured: At Day 14
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.
Measured: Up to Day 14 and Day 60
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.
Measured: Baseline, Day 14
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.
Measured: At Day 14 and Day 28
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.
Measured: Baseline up to Day 60
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.
Measured: Baseline up to Day 28
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.
Measured: Baseline, Day 14 and Day 28
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.
Measured: Baseline, 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
Percentage of participants who were alive and tested negative for COVID-19 at Day 14, Day 28, and Day 60 were reported.
Measured: At Day 14, Day 28 and Day 60
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.
Measured: Day 1 up to Day 60
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.
Measured: Day 1 up to Day 60
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.
Measured: Baseline up to Day 60
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.
Measured: Baseline up to Day 60
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.
Measured: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
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.
Measured: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
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.
Measured: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Apparent Body Clearance (CL/F) of MP1032
Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported.
Measured: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
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.
Measured: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032
Ctrough of MP1032 in plasma was reported.
Measured: Pre-dose concentration (Day 2, Day 7, and Day 8).
Average Observed Plasma Concentration at Steady State of MP1032
Average observed plasma concentration at steady state of MP1032 was reported.
Measured: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start19 Oct 2021
- Primary completion28 Jul 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetrioPharm AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932941
- Sponsor's protocol ID
- MP1032-CT05
- Other IDs
- 2021-000344-21
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2021
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04932941
- Acronym / sponsor ID
- MP1032-CT05
- Conditions
- COVID-19
- Keywords
- COVID-19, MP1032
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- MetrioPharm AGIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP1032 | Experimental | Drug: MP1032Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to MP1032 with hospital selected SoC for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP1032Hard gelatin capsules for oral administration. | Drug | MP1032 |
| PlaceboPlacebo capsules matched to MP1032 for oral administration. | Drug | Placebo |
Primary outcome
Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
Time frame: 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.
24 secondary outcomes
Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28
Time frame: At Day 28
Percentage of Participants With Disease Resolution at Day 28
Time frame: At Day 28
All-cause Mortality Rate up to Day 28
Time frame: Up to Day 28
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28
Time frame: Baseline, Day 28
Percentage of Participants With Disease Resolution at Day 14
Time frame: At Day 14
All-cause Mortality Rate up to Day 14 and Day 60
Time frame: Up to Day 14 and Day 60
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14
Time frame: Baseline, Day 14
Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28
Time frame: At Day 14 and Day 28
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit
Time frame: Baseline up to Day 60
Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale
Time frame: Baseline up to Day 28
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
Time frame: Baseline, Day 14 and Day 28
Time to Discharge by Day 28 and Day 60
Time frame: Baseline, 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
Time frame: At Day 14, Day 28 and Day 60
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Day 1 up to Day 60
Number of Participants With Clinically Significant Change in Vital Sign
Time frame: Day 1 up to Day 60
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
Time frame: Baseline up to Day 60
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results
Time frame: Baseline up to Day 60
Maximum Observed Plasma Concentration (Cmax) of MP1032
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Apparent Elimination Rate Constant (Kel) of MP1032
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Apparent Body Clearance (CL/F) of MP1032
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Apparent Volume of Distribution (Vz/F) of MP1032
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032
Time frame: Pre-dose concentration (Day 2, Day 7, and Day 8).
Average Observed Plasma Concentration at Steady State of MP1032
Time frame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MP1032 in people with COVID-19, run by MetrioPharm AG at 31 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Bulgaria, Italy, Spain, Romania, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 (time frame: At Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.