At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 149 enrolled
Drug / intervention
M5049 +2 moredrug
Likely dose
M5049 50 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia (ANEMONE)
EMD Serono Research & Development Institute, Inc.·interventional·Posted Jun 26, 2020·Updated Jun 6, 2022
In Brief
A Phase 2 clinical trial evaluating M5049 and Placebo for Coronavirus Disease 2019. Completed, enrolled 149 participants across 21 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronavirus Disease 2019
CountriesBrazil, Philippines, United States
CollaboratorsMerck KGaA, Darmstadt, Germany
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJul 2020
Primary CompletionAug 2021
TodayJul 2026
First PostedJun 26, 2020
Enrollment StartJul 29, 2020
Primary CompletionAug 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.0 years ago
Interventions
M5049drug
Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
M5049drug
Participants received M5049 100 mg orally twice daily for 14 days.
Placebodrug
Participants received placebo tablets matched to M5049 daily for 14 days.