Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. )

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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Drug: M5049 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : November 13, 2020
Estimated Study Completion Date : November 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: M5049 100 mg Drug: M5049
Participants will take M5049 100 milligram (mg) orally each day for 14 days.

Experimental: M5049 200 mg Drug: M5049
Participants will take M5049 200 mg orally each day for 14 days.

Placebo Comparator: Placebo Drug: Placebo
Participants will take placebo tablets matched to M5049 daily for 14 days.




Primary Outcome Measures :
  1. Percentage of Participants Alive and not Requiring Supplemental Oxygenation [ Time Frame: Day 14 ]
  2. 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 ]
  3. Number of Participants With Clinically Significant Changes in Laboratory Parameters and Electrocardiogram Findings [ Time Frame: Day 1 through Day 28 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Percentage of Participants With All-Cause Mortality [ Time Frame: Day 1 through Day 28 ]
    Percentage of Participants who die for any reason.

  4. Clinical Deterioration: Time to Intensive Care Unit (ICU) Admission [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration

  5. Clinical Deterioration: Time to Invasive Mechanical Ventilation [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration

  6. Clinical Deterioration: Time to Non-Invasive Mechanical Ventilation [ Time Frame: Day 1 through Day 28 ]
    Clinical Deterioration

  7. Total Length of Stay in Intensive Care Unit (ICU) [ Time Frame: Day 1 through Day 60 ]
  8. Total Length of Hospitalization Stay [ Time Frame: Day 1 through Day 60 ]
  9. Percentage of Participants Alive and not Requiring Supplemental Oxygenation [ Time Frame: Day 1 through Day 28 ]
  10. Percentage Change From Baseline in Inflammatory Biomarkers [ Time Frame: Day 1 through Day 28 ]
  11. Percentage Change From Baseline in Cytokine Biomarkers [ Time Frame: Day 1 through Day 28 ]
  12. 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.

  13. Percentage of Participants who are Re-Hospitalized [ Time Frame: Day 5 through Day 60 ]
    Percentage or participants who are re-hospitalized for any reason.

  14. Maximum Observed Concentration (Cmax) of M5049 [ Time Frame: Day 1 and Day 7 ]
    Only the first 15 participants will be evaluated for Pharmacokinetic parameters.

  15. Time to Reach the Maximum Observed Concentration (tmax) of M5049 [ Time Frame: Day 1 and Day 7 ]
  16. Terminal Rate Constant (Lambda z) of M5049 [ Time Frame: Day 1 and Day 7 ]
  17. Apparent Elimination Half-Life (t1/2) of M5049 [ Time Frame: Day 1 and Day 7 ]
  18. 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 ]
  19. 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 ]
  20. Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity) of M5049 [ Time Frame: Day 1 and Day 7 ]
  21. Apparent Total Body Clearance (CL/F) of M5049 [ Time Frame: Day 1 and Day 7 ]
  22. Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of M5049 [ Time Frame: Day 1 and Day 7 ]
  23. Dose-Normalized Maximum Observed Concentration (Cmax/Dose) of M5049 [ Time Frame: Day 1 and Day 7 ]
  24. 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 ]
  25. 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 ]
  26. 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 ]
  27. 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 ]
  28. Accumulation Ratio for Maximum Observed Concentration [Racc(Cmax)] of M5049 [ Time Frame: Day 1 and Day 7 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448756


Contacts
Layout table for location contacts
Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
Layout table for location information
United States, Alabama
University of Alabama-Birmingham Hospital Withdrawn
Birmingham, Alabama, United States, 35233
United States, California
LAC-USC Medical Center Not yet recruiting
Los Angeles, California, United States, 90033
Sharp Chula Vista Medical Center Recruiting
San Diego, California, United States, 92123
United States, Michigan
Henry Ford Medical Center Recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Saint Louis University - Saint Louis University Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, Texas
Christus Spohn Hospital Corpus Christi-Memorial Not yet recruiting
Corpus Christi, Texas, United States, 78404
Brazil
Santa Casa de Misericórdia de Belo Horizonte Recruiting
Belo Horizonte, Brazil
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, Brazil
Hospital Leforte Morumbi Not yet recruiting
Sao Paulo, Brazil
Hospital Alemão Oswaldo Cruz Not yet recruiting
São Paulo, Brazil
Hospital Bandeirantes / Hospital Leforte Liberdade Not yet recruiting
São Paulo, Brazil
Instituto de Infectologia Emílio Ribas Not yet recruiting
São Paulo, Brazil
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Additional Information:
Layout table for additonal information
Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT04448756    
Other Study ID Numbers: MS200569_0026
2020-002248-22 ( EudraCT Number )
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
COVID-19
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases