A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

June 11, 2020

Primary Completion Date

January 12, 2021

Study Completion Date

February 23, 2021

Conditions
COVID-19
Interventions
DRUG

IMU-838

"Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable).~If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube."

OTHER

Placebo

Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838

Trial Locations (4)

1606

Military Medical Academy, Clinic of Infectious Diseases, Sofia

UMHATEM N.I.Pirogov, Clinic of internal diseases, Sofia

30625

Clinic of the Hannover Medical School, Pneumology Clinic, Hanover

60590

University Hospital Frankfurt, Infectious Diseases, Frankfurt

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

FGK Clinical Research GmbH

INDUSTRY

lead

Immunic AG

INDUSTRY