Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Coronavirus Disease 2019

Treatments: Drug: Placebo; Drug: M5049

Study type: Interventional

Funder types: Industry

Identifiers

NCT04448756

MS200569_0026

2020-002248-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 3 patient groups, including a placebo group

M5049 50 mg

Experimental group

Treatment:

Drug: M5049

Drug: M5049

M5049 100 mg

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo