MP1032 Treatment in Patients With Moderate to Severe COVID-19

M

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

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

Trial documents
2

Trial contacts and locations

31

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems