Coronavirus Disease 2019Phase 2NCT04448756

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

A Phase 2 study testing M5049 in people with Coronavirus Disease 2019, run by EMD Serono Research & Development Institute, Inc. at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronavirus Disease 2019
What is being tested?: M5049
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 149 participants
Where: 21 sitesin 3 countries
Study dates: 29 Jul 2020to 16 Aug 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

Brazil10 sites

Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte
Hospital Dia do Pulmão
Blumenau
Hospital São José - Sociedade Literária e Caritativa Santo Agostinho
Criciúma
Hospital de Clínicas de Porto Alegre
Porto Alegre
HMCG - Hospital e Maternidade Dr. Christovão da Gama
Santo André
Pesquisare
Santo André
Hospital Alemão Oswaldo Cruz
São Paulo
Hospital Bandeirantes / Hospital Leforte Liberdade
São Paulo
Hospital Leforte Morumbi
São Paulo
Instituto de Infectologia Emílio Ribas
São Paulo

Other trials in Brazil

Philippines6 sites

Manila Doctors Hospital
Manila
Medical Center Manila - Medicine
Manila
Lung Center of the Philippines - Medicine
Quezon
Quirino Memorial Medical Center
Quezon
Veterans Memorial Medical Center
Quezon
East Avenue Medical Center
Quezon City

Other trials in Philippines

United States5 sites

Christus Spohn Hospital Corpus Christi-Memorial
Corpus Christi, Texas, 78404
Henry Ford Medical Center
Detroit, Michigan, 48202
LAC-USC Medical Center
Los Angeles, California, 90033
Sharp Chula Vista Medical Center
San Diego, California, 92123
Holy Name Hospital - Dept of Multiple Sclerosis Comp Care Center
Teaneck, New Jersey, 07666

Other trials in United States

About this study

Official title: 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)

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: Coronavirus Disease 2019
Being tested: M5049, Placebo
Keywords: COVID-19, Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04448756
Study group	Role	What they receive
M5049 50 mg	Experimental	Not described Receives: Drug: M5049
M5049 100 mg	Experimental	Not described Receives: Drug: M5049
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Recovery
Time to recovery was defined as the time from first dose (Day 1) to first occurrence of World Health Organization (WHO) 9-point ordinal scale 3 or less. The scoring is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or Extracorporeal membrane oxygenation (ECMO); 8. Death.
Measured: Day 1 through Day 28
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
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.
Measured: Day 1 through Day 60
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Laboratory investigation included hematology and biochemistry. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator.
Measured: Day 1 through Day 28
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
Measured: Day 1 through Day 28

Secondary outcomes (14)

Percentage of Participants Alive and Not Requiring Supplemental Oxygenation
The percentage of participants who were alive and did not require supplemental oxygenation or ventilatory support (including noninvasive or mechanical ventilation and Extra Corporeal Membrane Oxygenation [ECMO]) reported.
Measured: Day 3, Day 7, Day 14, Day 21 and Day 28
Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale
Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or ECMO; 8. Death.
Measured: Baseline, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 14, Day 21, Day 28, Day 44, Day 60
Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 measured by pulse oximetry. The time to SPO2 greater than or equal to (>=) 94 percent (%) sustained for at least 24 hours in room air is reported in days.
Measured: Day 1 through Day 28
Percentage of Participants With All-Cause Mortality
Percentage of Participants who died for any reason reported.
Measured: Day 1 through Day 60
Time to Intensive Care Unit (ICU) Admission
Time to ICU admission was defined as the time from first dose (Day 1) to the date/time of ICU admission, or death, whichever occurs first, in days. Event-free survival function for time to event (ICU admission or death) estimated via Kaplan-Meier method.
Measured: Day 1 through Day 28
Time to Non-Invasive Mechanical Ventilation
Time to non-invasive mechanical ventilation was defined as the time from first dose (Day 1) to the date/time of clinical status >= 5, in days. Event-free survival function for time to event (Non-invasive mechanical ventilation or death) estimated via Kaplan-Meier method. Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors, and ECMO; 8. Death
Measured: Day 1 through Day 28
Time to Invasive Mechanical Ventilation
Time to invasive mechanical ventilation was defined as the time from first dose (Day 1) to the date/time of clinical status >= 6, in days. Event-free survival function for time to event (invasive mechanical ventilation or death) estimated via Kaplan-Meier method. Clinical status was based on data collected on the 'Ordinal Scale for Clinical Status and is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors, and ECMO; 8. Death.
Measured: Day 1 through Day 28
Total Length of Stay in Intensive Care Unit (ICU)
Total days in the ICU was defined as the sum, for all ICU admissions, of the time from ICU admission to the date of ICU discharge, in days.
Measured: Day 1 through Day 60
Total Length of Hospitalization Stay
Total days in the hospital was defined as the sum, for all hospitalization events, of the time from first dose to the date of hospital discharge in days.
Measured: Day 1 through Day 60
Time to Hospital Discharge
The time to hospital discharge, defined as the time from first dose (Day 1) to the date of first hospitalization discharge, in days.
Measured: Day 1 through Day 60
Percent Change From Baseline in Inflammatory Biomarkers Over Time
C-Reactive Protein, D-Dimer and Ferritin inflammatory biomarkers were analyzed for this study. Percent Change From Baseline in Inflammatory Biomarkers Over Time were reported here.
Measured: Baseline, Day 3, Day7, Day 10, Day 14 and Day 28
Percent Change From Baseline in Serum Cytokine Biomarkers
Interleukin 6 and Interleukin 8 serum cytokine biomarkers were analyzed. Percent Change From Baseline in Serum Cytokine Biomarkers were reported.
Measured: Baseline, Day 3, Day7, Day 14 and Day 28
Percentage of Participants With Relapse
Relapse refers to rehospitalization due to worsening oxygenation, with either a positive result of any respiratory pathogenic nucleic acid test, or worsening lesions on chest imaging.
Measured: Day 5 through Day 60
Percentage of Participants Who Are Re-Hospitalized
Percentage or participants who are re-hospitalized due to coronavirus disease 2019 (Covid-19) complications were reported.
Measured: Day 5 through Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 202016 Aug 2021

First posted26 Jun 2020
Study start29 Jul 2020
Primary completion16 Aug 2021
Study completion16 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04448756
Sponsor's protocol ID: MS200569_0026
Other IDs: 2020-002248-22
Status last verified: May 2022
First submitted: 25 Jun 2020
Last updated: 6 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

McKinnon JE, Santiaguel J, Murta de Oliveira C, Yu D, Khursheed M, Moreau F, Klopp-Schulze L, Shaw J, Roy S, Kao AH; ANEMONE Study Team. Enpatoran in COVID-19 pneumonia: Safety and efficacy results from a phase II randomized trial. Clin Transl Sci. 2023 Dec;16(12):2640-2653. doi: 10.1111/cts.13658. Epub 2023 Oct 23.
PubMed 37873555
Klopp-Schulze L, Shaw JV, Dong JQ, Khandelwal A, Vazquez-Mateo C, Goteti K. Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need. Clin Pharmacol Ther. 2022 Aug;112(2):297-306. doi: 10.1002/cpt.2606. Epub 2022 May 21.
PubMed 35390178

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04448756
Acronym / sponsor ID: MS200569_0026
Conditions: Coronavirus Disease 2019
Keywords: COVID-19, Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
Collaborators: Merck KGaA, Darmstadt, Germany
Study start: 29 Jul 2020 (actual)
Primary completion: 16 Aug 2021 (actual)
Study completion: 16 Aug 2021 (actual)
First posted: 26 Jun 2020 (actual)
Results: Posted 6 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
M5049 50 mg	Experimental	Drug: M5049
M5049 100 mg	Experimental	Drug: M5049
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
M5049Participants received M5049 50 milligram (mg) orally twice daily for 14 days.	Drug	M5049 50 mg
M5049Participants received M5049 100 mg orally twice daily for 14 days.	Drug	M5049 100 mg
PlaceboParticipants received placebo tablets matched to M5049 daily for 14 days.	Drug	Placebo

Primary outcome

Time to Recovery
Time frame: Day 1 through Day 28
Time to recovery was defined as the time from first dose (Day 1) to first occurrence of World Health Organization (WHO) 9-point ordinal scale 3 or less. The scoring is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or Extracorporeal membrane oxygenation (ECMO); 8. Death.
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
Time frame: Day 1 through Day 60
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Time frame: Day 1 through Day 28
Laboratory investigation included hematology and biochemistry. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements
Time frame: Day 1 through Day 28
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.

14 secondary outcomes

Percentage of Participants Alive and Not Requiring Supplemental Oxygenation
Time frame: Day 3, Day 7, Day 14, Day 21 and Day 28
Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale
Time frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 14, Day 21, Day 28, Day 44, Day 60
Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air
Time frame: Day 1 through Day 28
Percentage of Participants With All-Cause Mortality
Time frame: Day 1 through Day 60
Time to Intensive Care Unit (ICU) Admission
Time frame: Day 1 through Day 28
Time to Non-Invasive Mechanical Ventilation
Time frame: Day 1 through Day 28
Time to Invasive Mechanical Ventilation
Time frame: Day 1 through Day 28
Total Length of Stay in Intensive Care Unit (ICU)
Time frame: Day 1 through Day 60
Total Length of Hospitalization Stay
Time frame: Day 1 through Day 60
Time to Hospital Discharge
Time frame: Day 1 through Day 60
Percent Change From Baseline in Inflammatory Biomarkers Over Time
Time frame: Baseline, Day 3, Day7, Day 10, Day 14 and Day 28
Percent Change From Baseline in Serum Cytokine Biomarkers
Time frame: Baseline, Day 3, Day7, Day 14 and Day 28
Percentage of Participants With Relapse
Time frame: Day 5 through Day 60
Percentage of Participants Who Are Re-Hospitalized
Time frame: Day 5 through Day 60

Results and safety

Results posted to the registry on 6 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	49	46
M5049 50 Milligram (mg)	54	49
M5049 100 mg	46	45

Primary outcome: Time to Recovery

Time frame: Day 1 through Day 28. Median (95% Confidence Interval). Unit: Days

Measure	Placebo n = 49	M5049 50 Milligram (mg) n = 54	M5049 100 mg n = 46
Value	3.4 (2.7 to 4.9)	3.7 (2.6 to 4.0)	3.9 (2.0 to 4.8)

Population analysed: Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention.

Primary outcome: 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

Time frame: Day 1 through Day 60. Count of participants. Unit: Participants

Measure	Placebo n = 49	M5049 50 Milligram (mg) n = 54	M5049 100 mg n = 46
Participants with any TEAE	28	34	26
Participants with any AESIs	2	2	0
Participants with TEAEs leading to discontinuation	4	4	1
Participants with Serious TEAEs	9	5	1

Population analysed: Safety analysis set included all participants who had received at least one dose of study intervention.

Primary outcome: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters

Time frame: Day 1 through Day 28. Count of participants. Unit: Participants

Measure	Placebo n = 49	M5049 50 Milligram (mg) n = 54	M5049 100 mg n = 46
Value	0	0	0

Population analysed: Safety analysis set included all participants who had received at least one dose of study intervention.

Primary outcome: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements

Time frame: Day 1 through Day 28. Count of participants. Unit: Participants

Measure	Placebo n = 49	M5049 50 Milligram (mg) n = 54	M5049 100 mg n = 46
Value	1	0	0

Population analysed: Safety analysis set included all participants who had received at least one dose of study intervention.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 60. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	9 of 49 (18.4%)	12 of 49 (24.5%)	2 of 49
M5049 50 Milligram (mg)	5 of 54 (9.3%)	15 of 54 (27.8%)	1 of 54
M5049 100 mg	1 of 46 (2.2%)	10 of 46 (21.7%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37873555McKinnon JE, Santiaguel J, Murta de Oliveira C, Yu D, Khursheed M, Moreau F, Klopp-Schulze L, Shaw J, Roy S, Kao AH; ANEMONE Study Team. Enpatoran in COVID-19 pneumonia: Safety and efficacy results from a phase II randomized trial. Clin Transl Sci. 2023 Dec;16(12):2640-2653. doi: 10.1111/cts.13658. Epub 2023 Oct 23.
Derived from this study: PubMed 35390178Klopp-Schulze L, Shaw JV, Dong JQ, Khandelwal A, Vazquez-Mateo C, Goteti K. Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need. Clin Pharmacol Ther. 2022 Aug;112(2):297-306. doi: 10.1002/cpt.2606. Epub 2022 May 21.
Trial Awareness and Transparency websiteLink provided by the sponsor.
US Medical Information website, Medical ResourcesLink provided by the sponsor.
Individual participant dataSharing planned: Yes. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Responsible study director

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing M5049 in people with Coronavirus Disease 2019, run by EMD Serono Research & Development Institute, Inc. at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Brazil, Philippines, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Recovery (time frame: Day 1 through Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448756, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.