Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Condition: Coronavirus Disease 2019
MeSH terms: COVID-19; Pneumonia; Coronavirus Infections
Intervention: M5049; M5049; Placebo
Intervention description: Participants received M5049 50 milligram (mg) orally twice daily for 14 days.; Participants received M5049 100 mg orally twice daily for 14 days.; Participants received placebo tablets matched to M5049 daily for 14 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COVID-19; Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)

Summary:

      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.
    

Eligibility criteria:

        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