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Purpose

The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant provides signed informed consent prior to the initiation of any study assessments - Has laboratory-confirmed SARS-CoV-2 Infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - Has chest imaging consistent with COVID-19 pneumonia (as per locally accepted guidelines) If chest imaging is not available during Screening, please discuss with Medical Monitor or designee regarding evidence of probable COVID-19 pneumonia for study participant eligibility - Not on mechanical ventilation or ECMO - Has an SpO2 less than (<) 94 percent in room air And able to maintain a partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) greater than or equal to (>=) 150 (Or equivalent SpO2/FiO2 >=190) with a maximum FiO2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 Liter), assess their current baseline oxygen requirements for eligibility - Requires hospitalization - Other protocol defined inclusion criteria may apply

Exclusion Criteria

  • Any condition that could interfere with the study objectives, conduct or evaluation in the opinion of the Investigator or Sponsor or designee - Significantly uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological associated with seizures (example: cerebrovascular accident/stroke, acute brain infection, traumatic brain injury, progressive brain disease, congenital brain disease or neuropsychiatric disorder) - Known active infection other than COVID-19 - Pregnancy or Breastfeeding - Other protocol defined exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
M5049 50 mg
  • Drug: M5049
    Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
Experimental
M5049 100 mg
  • Drug: M5049
    Participants received M5049 100 mg orally twice daily for 14 days.
Placebo Comparator
Placebo
  • Drug: Placebo
    Participants received placebo tablets matched to M5049 daily for 14 days.

Recruiting Locations

More Details

NCT ID
NCT04448756
Status
Completed
Sponsor
EMD Serono Research & Development Institute, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.