Clinical trial NCT04932941: MP1032 Treatment in Patients With Moderate to Severe COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept, Phase IIA Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Participants With Moderate to Severe COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
MP1032
Lead sponsor: MetrioPharm AG
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2021-06-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
timeFrame: At Day 14
Secondary outcomes:
measure: Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28
timeFrame: At Day 28
measure: Percentage of Participants With Disease Resolution at Day 28
timeFrame: At Day 28
measure: All-cause Mortality Rate up to Day 28
timeFrame: Up to Day 28
measure: Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28
timeFrame: Baseline, Day 28
measure: Percentage of Participants With Disease Resolution at Day 14
timeFrame: At Day 14
measure: All-cause Mortality Rate up to Day 14 and Day 60
timeFrame: Up to Day 14 and Day 60
measure: Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14
timeFrame: Baseline, Day 14
measure: Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28
timeFrame: At Day 14 and Day 28
measure: Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit
timeFrame: Baseline up to Day 60
measure: Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale
timeFrame: Baseline up to Day 28
measure: 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
timeFrame: Baseline, Day 14 and Day 28
measure: Time to Discharge by Day 28 and Day 60
timeFrame: Baseline, Day 28 and Day 60
measure: Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60
timeFrame: At Day 14, Day 28 and Day 60
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Day 1 up to Day 60
measure: Number of Participants With Clinically Significant Change in Vital Sign
timeFrame: Day 1 up to Day 60
measure: Number of Participants With Clinically Significant Abnormalities in Physical Examinations
timeFrame: Baseline up to Day 60
measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results
timeFrame: Baseline up to Day 60
measure: Maximum Observed Plasma Concentration (Cmax) of MP1032
timeFrame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032
timeFrame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
measure: Apparent Elimination Rate Constant (Kel) of MP1032
timeFrame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
measure: Apparent Body Clearance (CL/F) of MP1032
timeFrame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
measure: Apparent Volume of Distribution (Vz/F) of MP1032
timeFrame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
measure: Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032
timeFrame: Pre-dose concentration (Day 2, Day 7, and Day 8).
measure: Average Observed Plasma Concentration at Steady State of MP1032
timeFrame: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Snake River Research PLLC
state: Idaho
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Blagoevgrad
country: Bulgaria
facility: MHAT Blagoevgrad AD
city: Kozloduy
country: Bulgaria
facility: MHAT Sv. Ivan Rilski Kozloduy
city: Montana
country: Bulgaria
facility: MHAT Dr. Stamen Iliev AD
city: Pernik
country: Bulgaria
facility: SHATPD Pernik EOOD
city: Sliven
country: Bulgaria
facility: MHAT Dr. Ivan Seliminski AD
city: Sofia
country: Bulgaria
facility: Umhatem"N.I.Pirogov"
city: Stara Zagora
country: Bulgaria
facility: SHATPPD Sata Zagora EOOD
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble Alpes
city: Pierre-Benite CEDEX
country: France
facility: Centre Hospitalier Lyon Sud
city: Debrecen
country: Hungary
facility: DE KK Infektológiai Klinika
city: Kistarcsa
country: Hungary
facility: Flor Ferenc Hospital of Pest County
city: Forlì
country: Italy
facility: Ospedale GB Morgagni
city: Latina
country: Italy
facility: Ospedale SM Goretti
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milan
country: Italy
facility: ASST-FBF-SACCO - Ospedale Luigi Sacco
city: Napoli
country: Italy
facility: Policlinico di Napoli
city: Pescara
country: Italy
facility: Ospedale "Santo Spirito! Pescara
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Bucharest
country: Romania
facility: Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
city: Caracal
country: Romania
facility: Spitalul Municipal Caracal
city: Iaşi
country: Romania
facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"
city: Timişoara
country: Romania
facility: Clinica Anestezie si Terapie Intensiva
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona Hospital Clinic i Provincial
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal, Edificio Central
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla/IDIVAL
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
References: