Status:
COMPLETED
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Coronavirus Disease 2019
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2021
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04448756
Start Date
July 29 2020
End Date
August 16 2021
Last Update
June 6 2022
Active Locations (21)
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1
LAC-USC Medical Center
Los Angeles, California, United States, 90033
2
Sharp Chula Vista Medical Center
San Diego, California, United States, 92123
3
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
4
Holy Name Hospital - Dept of Multiple Sclerosis Comp Care Center
Teaneck, New Jersey, United States, 07666