Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)

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

  • Coronavirus Disease 2019

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.