MP1032 Treatment in Patients With Moderate to Severe COVID-19

MetrioPharm

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: MP1032; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04932941

2021-000344-21 (EudraCT Number)

MP1032-CT05

Details and patient eligibility

About

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).

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

MP1032

Experimental group

Description:

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

Treatment:

Drug: MP1032

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo