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

NCT04448756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2022-06-06

Study results available
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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.

Conditions

  • Coronavirus Disease 2019

Interventions

DRUG

M5049

Participants received M5049 50 milligram (mg) orally twice daily for 14 days.

DRUG

M5049

Participants received M5049 100 mg orally twice daily for 14 days.

DRUG

Placebo

Participants received placebo tablets matched to M5049 daily for 14 days.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-08-16
Completion
2021-08-16
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Philippines

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448756 on ClinicalTrials.gov