MP1032 Treatment in Patients With Moderate to Severe COVID-19

NCT ID: NCT04932941

Last Updated: 2023-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2022-09-05

Brief Summary

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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).

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MP1032

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

Group Type EXPERIMENTAL

MP1032

Intervention Type DRUG

Hard gelatin capsules for oral administration.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules matched to MP1032 for oral administration.

Interventions

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MP1032

Hard gelatin capsules for oral administration.

Intervention Type DRUG

Placebo

Placebo capsules matched to MP1032 for oral administration.

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

MetrioPharm AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Snake River Research PLLC

Idaho Falls, Idaho, United States

Site Status

Richmond University Medical Center

Staten Island, New York, United States

Site Status

MHAT Blagoevgrad AD

Blagoevgrad, , Bulgaria

Site Status

MHAT Sv. Ivan Rilski Kozloduy

Kozloduy, , Bulgaria

Site Status

MHAT Dr. Stamen Iliev AD

Montana, , Bulgaria

Site Status

SHATPD Pernik EOOD

Pernik, , Bulgaria

Site Status

MHAT Dr. Ivan Seliminski AD

Sliven, , Bulgaria

Site Status

Umhatem"N.I.Pirogov"

Sofia, , Bulgaria

Site Status

SHATPPD Sata Zagora EOOD

Stara Zagora, , Bulgaria

Site Status

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Site Status

CHU de Grenoble Alpes

Grenoble, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

DE KK Infektológiai Klinika

Debrecen, , Hungary

Site Status

Flor Ferenc Hospital of Pest County

Kistarcsa, , Hungary

Site Status

Ospedale GB Morgagni

Forlì, , Italy

Site Status

Ospedale SM Goretti

Latina, , Italy

Site Status

ASST-FBF-SACCO - Ospedale Luigi Sacco

Milan, , Italy

Site Status

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Policlinico di Napoli

Napoli, , Italy

Site Status

Ospedale "Santo Spirito! Pescara

Pescara, , Italy

Site Status

Policlinico Agostino Gemelli

Roma, , Italy

Site Status

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

Bucharest, , Romania

Site Status

Spitalul Municipal Caracal

Caracal, , Romania

Site Status

Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"

Iași, , Romania

Site Status

Clinica Anestezie si Terapie Intensiva

Timișoara, , Romania

Site Status

Hospital Clinic de Barcelona Hospital Clinic i Provincial

Barcelona, , Spain

Site Status

Hospital Ramon y Cajal, Edificio Central

Madrid, , Spain

Site Status

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla/IDIVAL

Santander, , Spain

Site Status

Hospital Universitario de Valme

Seville, , Spain

Site Status

Hospital Álvaro Cunqueiro

Vigo, , Spain

Site Status

Countries

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United States Bulgaria France Hungary Italy Romania Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2021-000344-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MP1032-CT05

Identifier Type: -

Identifier Source: org_study_id

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