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.
Drug: M5049
Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
Drug: M5049
Participants received M5049 100 mg orally twice daily for 14 days.
Drug: Placebo
Participants received placebo tablets matched to M5049 daily for 14 days.
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
LAC-USC Medical Center
Los Angeles, California, United States
Sharp Chula Vista Medical Center
San Diego, California, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Holy Name Hospital - Dept of Multiple Sclerosis Comp Care Center
Teaneck, New Jersey, United States
Christus Spohn Hospital Corpus Christi-Memorial
Corpus Christi, Texas, United States
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Brazil
Hospital Dia do Pulmão
Blumenau, Brazil
Hospital São José - Sociedade Literária e Caritativa Santo Agostinho
Criciúma, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
HMCG - Hospital e Maternidade Dr. Christovão da Gama
Santo André, Brazil
Pesquisare
Santo André, Brazil
Hospital Leforte Morumbi
Sao Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Hospital Bandeirantes / Hospital Leforte Liberdade
São Paulo, Brazil
Instituto de Infectologia Emílio Ribas
São Paulo, Brazil
Manila Doctors Hospital
Manila, Philippines
Medical Center Manila - Medicine
Manila, Philippines
East Avenue Medical Center
Quezon City, Philippines
Lung Center of the Philippines - Medicine
Quezon, Philippines
Quirino Memorial Medical Center
Quezon, Philippines
Veterans Memorial Medical Center
Quezon, Philippines
Medical Responsible, Study Director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany