MP1032 Treatment in Patients With Moderate to Severe COVID-19

NCT04932941 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: MP1032-CT052021-000344-21
• Study Type: interventional
• Target: 132
• Locations: 7 countries
• Sites: 31

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).

Conditions

COVID-19

Keywords

COVID-19; MP1032

Outcome Measures

Primary Outcomes (1)

• 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.

  At Day 14

Secondary Outcomes (24)

• Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28

  At Day 28

• Percentage of Participants With Disease Resolution at Day 28

  At Day 28

• All-cause Mortality Rate up to Day 28

  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

  Baseline, Day 28

• Percentage of Participants With Disease Resolution at Day 14

  At Day 14

Study Arms (2)

MP1032

EXPERIMENTAL

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

Drug: MP1032

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MP1032 DRUG

Hard gelatin capsules for oral administration.

MP1032

Placebo DRUG

Placebo capsules matched to MP1032 for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetrioPharm AG: lead
• Syneos Health: collaborator

Study Sites (31)

Snake River Research PLLC

Idaho Falls, Idaho, 83404, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

MHAT Blagoevgrad AD

Blagoevgrad, Bulgaria

Location

MHAT Sv. Ivan Rilski Kozloduy

Kozloduy, Bulgaria

Location

MHAT Dr. Stamen Iliev AD

Montana, Bulgaria

Location

SHATPD Pernik EOOD

Pernik, Bulgaria

Location

MHAT Dr. Ivan Seliminski AD

Sliven, Bulgaria

Location

Umhatem"N.I.Pirogov"

Sofia, Bulgaria

Location

SHATPPD Sata Zagora EOOD

Stara Zagora, Bulgaria

Location

Centre Hospitalier Victor Dupouy

Argenteuil, France

Location

CHU de Grenoble Alpes

Grenoble, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

DE KK Infektológiai Klinika

Debrecen, Hungary

Location

Flor Ferenc Hospital of Pest County

Kistarcsa, Hungary

Location

Ospedale GB Morgagni

Forlì, Italy

Location

Ospedale SM Goretti

Latina, Italy

Location

ASST-FBF-SACCO - Ospedale Luigi Sacco

Milan, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Policlinico di Napoli

Napoli, Italy

Location

Ospedale "Santo Spirito! Pescara

Pescara, Italy

Location

Policlinico Agostino Gemelli

Roma, Italy

Location

Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

Bucharest, Romania

Location

Spitalul Municipal Caracal

Caracal, Romania

Location

Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"

Iași, Romania

Location

Clinica Anestezie si Terapie Intensiva

Timișoara, Romania

Location

Hospital Clinic de Barcelona Hospital Clinic i Provincial

Barcelona, Spain

Location

Hospital Ramon y Cajal, Edificio Central

Madrid, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Marqués de Valdecilla/IDIVAL

Santander, Spain

Location

Hospital Universitario de Valme

Seville, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

sodium luminolate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Disclosure Officer
• Organization: MetrioPharm Deutschland GmbH

info@metriopharm.com

+49303384395

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 21, 2021
• Study Start: October 19, 2021
• Primary Completion: July 28, 2022
• Study Completion: September 5, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (4); ES (6); IT (7); HU (2); US (2); FR (3); BU (7)