Phase 2
N=149
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Coronavirus Disease 2019
Bottom Line
View on ClinicalTrials.gov: NCT04448756 ↗Enrolled (actual)
149
Serious AEs
10.1%
Results posted
Jun 2022
Primary outcome: Primary: Time to Recovery — 3.4; 3.7; 3.9 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- M5049 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recovery |
3.4; 3.7; 3.9 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0 |
28; 34; 26; 2; 2; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters |
0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements |
1; 0; 0 | — |
| SECONDARY Percentage of Participants Alive and Not Requiring Supplemental Oxygenation |
30.6; 27.5; 38.6; 76.6; 83.3; 83.3 | — |
| SECONDARY Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air |
4.7; 4.8; 5.0 | — |
| SECONDARY Percentage of Participants With All-Cause Mortality |
4.1; 1.9; 0.0 | — |
| SECONDARY Time to Intensive Care Unit (ICU) Admission |
NA; NA; NA | — |
| SECONDARY Time to Non-Invasive Mechanical Ventilation |
NA; NA; NA | — |
| SECONDARY Time to Invasive Mechanical Ventilation |
NA; NA; NA | — |
| SECONDARY Total Length of Stay in Intensive Care Unit (ICU) |
7.1; 10.2; 3.7 | — |
| SECONDARY Total Length of Hospitalization Stay |
7.0; 6.0; 6.0 | — |
| SECONDARY Time to Hospital Discharge |
5.1; 5.1; 4.7 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Biomarkers Over Time |
-0.8; 48.2; -45.1; -48.1; -50.4; -74.3 | — |
| SECONDARY Percent Change From Baseline in Serum Cytokine Biomarkers |
51.2; -17.8; 1722.3; 35.2; 1.1; -25.5 | — |
| SECONDARY Percentage of Participants With Relapse |
0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Are Re-Hospitalized |
0.0; 0.0; 2.2 | — |
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 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 ( =) 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
Data sourced from ClinicalTrials.gov (NCT04448756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.