Official Title
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia (ANEMONE)
Brief 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.

Completed
Coronavirus Disease 2019

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Brazil
Philippines
United States
Locations

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

Merck KGaA, Darmstadt, Germany
NCT Number
Keywords
Covid-19
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
MeSH Terms
COVID-19
Pneumonia
Coronavirus Infections