Multiple Sclerosis Clinical Trial
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
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
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There are 5 Locations for this study
Los Angeles California, 90033, United States
San Diego California, 92123, United States
Detroit Michigan, 48202, United States
Teaneck New Jersey, 07666, United States
Corpus Christi Texas, 78404, United States
Belo Horizonte , , Brazil
Blumenau , , Brazil
Criciúma , , Brazil
Porto Alegre , , Brazil
Santo André , , Brazil
Santo André , , Brazil
Sao Paulo , , Brazil
São Paulo , , Brazil
São Paulo , , Brazil
São Paulo , , Brazil
Manila , , Philippines
Manila , , Philippines
Quezon City , , Philippines
Quezon , , Philippines
Quezon , , Philippines
Quezon , , Philippines
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