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

MP1032-CT05

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).

2021-10-19

2022-07-28

2022-09-05

Completed

Early phase I

132

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 132, 'type': 'ACTUAL'}}

2023-06-29