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M5049 Study in Participants With Coronavirus Disease 2019 (COVID-19) Pneumonia (ANEMONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448756
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date  ICMJE June 25, 2020
First Posted Date  ICMJE June 26, 2020
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE July 29, 2020
Estimated Primary Completion Date November 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • Percentage of Participants Alive and not Requiring Supplemental Oxygenation [ Time Frame: Day 14 ]
  • Occurrence of Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious AEs (SAEs) [ Time Frame: Day 1 through Day 60 ]
  • Number of Participants With Clinically Significant Changes in Laboratory Parameters and Electrocardiogram Findings [ Time Frame: Day 1 through Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
  • Clinical Status of Participants on a 9-Point Ordinal Scale [ Time Frame: Day 1 through Day 60 ]
    A nine point ordinal scale - 0: Uninfected
    1. No limitation of activities
    2. Limitation of activities
    3. Hospitalized, mild disease on, no oxygen therapy
    4. Hospitalized, with 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 - example, vasopressors, Extracorporeal membrane oxygenation (ECMO)
    8. Death.
  • Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours on Room Air [ Time Frame: Day 1 through Day 28 ]
    Normal oxygen exchange in room air.
  • Percentage of Participants With All-Cause Mortality [ Time Frame: Day 1 through Day 28 ]
    Percentage of Participants who die for any reason.
  • Clinical Deterioration: Time to Intensive Care Unit (ICU) Admission [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration
  • Clinical Deterioration: Time to Invasive Mechanical Ventilation [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration
  • Clinical Deterioration: Time to Non-Invasive Mechanical Ventilation [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration
  • 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 ]
  • Percentage of Participants Alive and not Requiring Supplemental Oxygenation [ Time Frame: Day 1 through Day 28 ]
  • Percentage Change From Baseline in Inflammatory Biomarkers [ Time Frame: Day 1 through Day 28 ]
  • Percentage Change From Baseline in Cytokine Biomarkers [ Time Frame: Day 1 through Day 28 ]
  • Percentage of Participants With Relapse [ Time Frame: Day 5 through Day 60 ]
    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.
  • Percentage of Participants who are Re-Hospitalized [ Time Frame: Day 5 through Day 60 ]
    Percentage or participants who are re-hospitalized for any reason.
  • Maximum Observed Concentration (Cmax) of M5049 [ Time Frame: Day 1 and Day 7 ]
    Only the first 15 participants will be evaluated for Pharmacokinetic parameters.
  • Time to Reach the Maximum Observed Concentration (tmax) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Terminal Rate Constant (Lambda z) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Apparent Elimination Half-Life (t1/2) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Apparent Total Body Clearance (CL/F) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Maximum Observed Concentration (Cmax/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Accumulation Ratio for Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose [Racc(AUC0- 12h)] of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Accumulation Ratio for Maximum Observed Concentration [Racc(Cmax)] of M5049 [ Time Frame: Day 1 and Day 7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • Clinical Status of Participants on a 9-Point Ordinal Scale [ Time Frame: Day 1 through Day 60 ]
    A nine point ordinal scale - 0: Uninfected
    1. No limitation of activities
    2. Limitation of activities
    3. Hospitalized, mild disease on, no oxygen therapy
    4. Hospitalized, with 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 - example, vasopressors, Extracorporeal membrane oxygenation (ECMO)
    8. Death.
  • Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours on Room Air [ Time Frame: Day 1 through Day 28 ]
    Normal oxygen exchange in room air.
  • Percentage of Participants With All-Cause Mortality [ Time Frame: Day 1 through Day 28 ]
    Percentage of Participants who die for any reason.
  • Clinical Deterioration: Time to Intensive Care Unit (ICU) Admission [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration
  • Clinical Deterioration: Time to Invasive Mechanical Ventilation [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration
  • Clinical Deterioration: Time to Non-Invasive Mechanical Ventilation [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration
  • 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 ]
  • Percentage of Participants Alive and not Requiring Supplemental Oxygenation [ Time Frame: Day 1 through Day 28 ]
  • Percentage Change From Baseline in Inflammatory Biomarkers [ Time Frame: Day 1 through Day 28 ]
  • Percentage of Participants With Relapse [ Time Frame: Day 5 through Day 60 ]
    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.
  • Percentage of Participants who are Re-Hospitalized [ Time Frame: Day 5 through Day 60 ]
    Percentage or participants who are re-hospitalized for any reason.
  • Maximum Observed Concentration (Cmax) of M5049 [ Time Frame: Day 1 and Day 7 ]
    Only the first 15 participants will be evaluated for Pharmacokinetic parameters.
  • Time to Reach the Maximum Observed Concentration (tmax) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Terminal Rate Constant (Lambda z) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Apparent Elimination Half-Life (t1/2) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Apparent Total Body Clearance (CL/F) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Maximum Observed Concentration (Cmax/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  • Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE M5049 Study in Participants With Coronavirus Disease 2019 (COVID-19) Pneumonia
Official Title  ICMJE A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia
Brief Summary The study will evaluate the safety and efficacy of orally-administered M5049 in COVID-19 pneumonia participants who are hospitalized but not on mechanical ventilation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease 2019
Intervention  ICMJE
  • Drug: M5049
    Participants will take M5049 100 milligram (mg) orally each day for 14 days.
  • Drug: M5049
    Participants will take M5049 200 mg orally each day for 14 days.
  • Drug: Placebo
    Participants will take placebo tablets matched to M5049 daily for 14 days.
Study Arms  ICMJE
  • Experimental: M5049 100 mg
    Intervention: Drug: M5049
  • Experimental: M5049 200 mg
    Intervention: Drug: M5049
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 13, 2020
Estimated Primary Completion Date November 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant provides signed informed consent prior to the initiation of any study assessments
  • Documented test positive (NAT) for SARS-CoV-2 (based on locally acceptable accepted guidelines) if sampled within 10 days prior to randomization positive for SARS-CoV-2 based on locally acceptable guidelines (as per locally accepted guidelines)
  • Has chest imaging consistent with COVID-19 pneumonia (as per locally accepted guidelines)
  • 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 with a maximum FiO2 0.4
  • 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
  • Any uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological or neuropsychiatric disorder)
  • Known active infection other than COVID-19
  • Pregnancy or Breastfeeding
  • Other protocol defined exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com
Listed Location Countries  ICMJE Brazil,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04448756
Other Study ID Numbers  ICMJE MS200569_0026
2020-002248-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients 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 https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP