Trials / Completed
CompletedNCT04448756
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M5049 | Participants received M5049 50 milligram (mg) orally twice daily for 14 days. |
| DRUG | M5049 | Participants received M5049 100 mg orally twice daily for 14 days. |
| DRUG | Placebo | Participants received placebo tablets matched to M5049 daily for 14 days. |
Timeline
- Start date
- 2020-07-29
- Primary completion
- 2021-08-16
- Completion
- 2021-08-16
- First posted
- 2020-06-26
- Last updated
- 2022-06-06
- Results posted
- 2022-06-06
Locations
21 sites across 3 countries: United States, Brazil, Philippines
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04448756. Inclusion in this directory is not an endorsement.