Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Purpose
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.
Condition
- Coronavirus Disease 2019
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental M5049 50 mg |
|
|
Experimental M5049 100 mg |
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT04448756
- Status
- Completed
- Sponsor
- EMD Serono Research & Development Institute, Inc.