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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

149

Study ID:

NCT04448756

Recruitment Status:

Completed

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 5 Locations for this study

See Locations Near You

LAC-USC Medical Center
Los Angeles California, 90033, United States
Sharp Chula Vista Medical Center
San Diego California, 92123, United States
Henry Ford Medical Center
Detroit Michigan, 48202, United States
Holy Name Hospital - Dept of Multiple Sclerosis Comp Care Center
Teaneck New Jersey, 07666, United States
Christus Spohn Hospital Corpus Christi-Memorial
Corpus Christi Texas, 78404, 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

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

149

Study ID:

NCT04448756

Recruitment Status:

Completed

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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