Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Completed · Phase 2 · Has a placebo group
Conditions studied: Coronavirus Disease 2019
In brief
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.
Key facts
- Study ID
- NCT04448756
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 149
- Starts
- 2020-07-29
- Expected to finish
- 2021-08-16
- Last updated by the study team
- 2022-06-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 Alemão Oswaldo Cruz — São Paulo, Brazil
- Hospital Bandeirantes / Hospital Leforte Liberdade — São Paulo, Brazil
- Hospital Leforte Morumbi — São Paulo, Brazil
- Instituto de Infectologia Emílio Ribas — São Paulo, Brazil
- Manila Doctors Hospital — Manila, Philippines
- Medical Center Manila - Medicine — Manila, Philippines
- Lung Center of the Philippines - Medicine — Quezon, Philippines
- Quirino Memorial Medical Center — Quezon, Philippines
- Veterans Memorial Medical Center — Quezon, Philippines
- East Avenue Medical Center — Quezon City, Philippines
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.