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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002248-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M5049 50 mg | Experimental |
| |
| M5049 100 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5049 | Drug | Participants received M5049 50 milligram (mg) orally twice daily for 14 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 through Day 28 |
| Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 3, Day 7, Day 14, Day 21 and Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC-USC Medical Center | Los Angeles | California | 90033 | United States | ||
| Sharp Chula Vista Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37873555 | Derived | 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. | |
| 35390178 | Derived |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
Not provided
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
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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Overall, 200 participants were screened for this study. Of which, 149 participants were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matched placebo tablets to M5049 daily for 14 days. |
| FG001 | M5049 50 Milligram (mg) | Participants received M5049 50 milligram (mg) orally twice daily for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2021 | May 11, 2022 |
Not provided
Not provided
Not provided
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Not provided
| M5049 |
| Drug |
Participants received M5049 100 mg orally twice daily for 14 days. |
|
| Placebo | Drug | Participants received placebo tablets matched to M5049 daily for 14 days. |
|
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. |
| Day 1 through 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. |
| 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. | Day 1 through Day 28 |
| Percentage of Participants With All-Cause Mortality | Percentage of Participants who died for any reason reported. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 5 through Day 60 |
| San Diego |
| California |
| 92123 |
| United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| Holy Name Hospital - Dept of Multiple Sclerosis Comp Care Center | Teaneck | New Jersey | 07666 | United States |
| Christus Spohn Hospital Corpus Christi-Memorial | Corpus Christi | Texas | 78404 | United States |
| Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | Brazil |
| Hospital Dia do Pulmão | Blumenau | Brazil |
| Hospital São José - Sociedade Literária e Caritativa Santo Agostinho | Criciúma | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Brazil |
| HMCG - Hospital e Maternidade Dr. Christovão da Gama | Santo André | Brazil |
| Pesquisare | Santo André | Brazil |
| Hospital Alemão Oswaldo Cruz | São Paulo | Brazil |
| Hospital Bandeirantes / Hospital Leforte Liberdade | São Paulo | Brazil |
| Hospital Leforte Morumbi | São Paulo | Brazil |
| Instituto de Infectologia Emílio Ribas | São Paulo | Brazil |
| Manila Doctors Hospital | Manila | Philippines |
| Medical Center Manila - Medicine | Manila | Philippines |
| Lung Center of the Philippines - Medicine | Quezon | Philippines |
| Quirino Memorial Medical Center | Quezon | Philippines |
| Veterans Memorial Medical Center | Quezon | Philippines |
| East Avenue Medical Center | Quezon City | Philippines |
| 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. |
| US Medical Information website, Medical Resources | View source |
| FG002 | M5049 100 mg | Participants received M5049 100 mg orally twice daily for 14 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who had received at least one dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matched placebo tablets to M5049 daily for 14 days. |
| BG001 | M5049 50 Milligram (mg) | Participants received M5049 50 milligram (mg) orally twice daily for 14 days. |
| BG002 | M5049 100 mg | Participants received M5049 100 mg orally twice daily for 14 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Days | Day 1 through Day 28 |
|
|
| |||||||||||||||||||||||||||||||
| 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 | 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. | Safety analysis set included all participants who had received at least one dose of study intervention. | Posted | Count of Participants | Participants | Day 1 through Day 60 |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety analysis set included all participants who had received at least one dose of study intervention. | Posted | Count of Participants | Participants | Day 1 through Day 28 |
|
| |||||||||||||||||||||||||||||||||
| Primary | 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. | Safety analysis set included all participants who had received at least one dose of study intervention. | Posted | Count of Participants | Participants | Day 1 through Day 28 |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 3, Day 7, Day 14, Day 21 and Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Count of Participants | Participants | Baseline, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 14, Day 21, Day 28, Day 44, Day 60 |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Days | Day 1 through Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With All-Cause Mortality | Percentage of Participants who died for any reason reported. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 60 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Days | Day 1 through Day 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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 | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Days | Day 1 through Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Days | Day 1 through Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | Full Range | Days | Day 1 through Day 60 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | Full Range | Days | Day 1 through Day 60 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Days | Day 1 through Day 60 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Pharmacodynamics (PD) analysis set included all participants who received atleast 1 dose of study intervention, for whom atleast 1 postbaseline serum biomarker was obtained without any relevant protocol deviations or events that may have an influence on PD. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Mean | Standard Deviation | Percent change | Baseline, Day 3, Day7, Day 10, Day 14 and Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | PD analysis set included all participants who received at least 1 dose of study intervention, for whom at least 1 postbaseline serum biomarker was obtained without any relevant protocol deviations or events that may have an influence on PD. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Mean | Standard Deviation | Percent change | Baseline, Day 3, Day7, Day 14 and Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 5 through Day 60 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Re-Hospitalized | Percentage or participants who are re-hospitalized due to coronavirus disease 2019 (Covid-19) complications were reported. | Intent-to-Treat analysis set included all participants who had received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 5 through Day 60 |
|
|
Baseline up to Day 60
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matched placebo tablets to M5049 daily for 14 days. | 2 | 49 | 9 | 49 | 12 | 49 |
| EG001 | M5049 50 Milligram (mg) | Participants received M5049 50 milligram (mg) orally twice daily for 14 days. | 1 | 54 | 5 | 54 | 15 | 54 |
| EG002 | M5049 100 mg | Participants received M5049 100 mg orally twice daily for 14 days. | 0 | 46 | 1 | 46 | 10 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2021 | May 11, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | M5049 100 mg | Participants received M5049 100 mg orally twice daily for 14 days. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| OG002 | M5049 100 mg | Participants received M5049 100 mg orally twice daily for 14 days. |
|
|
| OG002 | M5049 100 mg | Participants received M5049 100 mg orally twice daily for 14 days. |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|