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)

NCT04379271 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: P2-IMU-838-COV
• Study Type: interventional
• Target: 234
• Locations: 2 countries
• Sites: 4

Brief Summary

At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor's choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood. Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Without Any Need for INV Until EoS

  Number of Participants Stratified as those With and Without the Need for INV Until End-of-study (EoS). For this outcome a worst case approach was used in which patients who were lost to follow-up or who discontinued the trial on or before Day 13 due to any other reason than death and discontinued with a last observed WHO clinical status no lower than that at Screening, and patients who died were considered as patients requiring INV.

  Throughout the Study (Day 0 to Day 28)

Secondary Outcomes (56)

• Days in ICU Department

  Throughout the Study (Day 0 to Day 28 )

• All Cause Mortality (ITT Approach)

  Throughout the Study (Day 0 to Day 28 )

• Time to Clinical Improvement

  Throughout the Study (Day 0 to Day 28)

• Days of Hospitalization

  Throughout the Study (Day 0 to Day 28 )

• Patients Free of Renal-replacement Therapy (RRT)* Until EoS

  Throughout the Study (Day 0 to Day 28 )

Study Arms (2)

IMU-838

EXPERIMENTAL

twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC)

Drug: IMU-838

Placebo

PLACEBO COMPARATOR

twice-daily (BID) oral placebo (+ SoC)

Other: Placebo

Interventions

IMU-838 DRUG

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.

Also known as: vidofludimus calcium

IMU-838

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients at least 18 years old (may be extended to include also children 12 years or older after the 1st interim analysis)
• Admitted to the hospital or other medical in-patient treatment facility for treatment of COVID-19 The hospitalization needs to be for medical reasons (treatment of COVID-19 disease) and cannot be for social reasons or due to housing insecurity.
• For US sites only: If the investigator would commonly hospitalize the patient but for healthcare resource reasons decides to treat the patient in a specially designed out-patient setting, then such patients are also allowed to enter the trial (please note that in this case the patient would be counted as clinical status category 3). The investigator then must assure that the patient has at least a twice daily assessment by qualified trial personnel and all laboratory assessments can be adequately performed as per protocol. The Sponsor reserves the right to discontinue this option via administrative letter if such assurances cannot be met by any site.
• SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) test in a nasopharyngeal, oropharyngeal or respiratory sample at ≤4 days before randomization
• Moderate COVID-19 disease defined as fulfilling clinical status category 3 or 4 on the WHO 9-point ordinal scale \[21\]:
• Category 3: Hospitalized (see note above for US only), virus-positive, no oxygen therapy with the following conditions:
• The hospitalization needs to be for medical reasons (treatment of COVID-19 disease) and cannot be for social reasons or due to housing insecurity
• Category 4: Hospitalized, virus-positive, oxygen by mask or nasal prongs (excluding high-flow oxygen therapy) with the following conditions:
• Peripheral capillary oxyhemoglobin saturation (SpO2) \>92% at maximum of 6 liters oxygen flow per minute
• Stable respiratory rate ≤30 breaths/min at maximum of 6 liters oxygen flow per minute
• Presence of at least 1 symptom characteristic for COVID-19 disease i.e., fever, cough or respiratory distress
• Willingness and ability to comply with the protocol
• Written informed consent given prior to any trial-related procedure
• For women of childbearing potential: Application of a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly) together with a barrier method between trial consent and 30 days after the last intake of the IMP.
• Highly effective forms of birth control are those with a failure rate less than 1% per year and include:

You may not qualify if:

• Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring in the near foreseeable future
• Critical patients whose expected survival time \<48-72 hours
• Presence of the following laboratory values at screening:
• White blood cell count (WBC) \<1.0 x 109/L
• Platelet count \<100,000/mm³ (\<100 x 109/L)
• Total bilirubin\>2 x ULN
• Alanine aminotransferase (ALT) or gamma glutamyl transferase (GGT) \>5 x ULN
• Participation in any other interventional clinical trial
• Hospitalization primarily for other reasons than COVID-19 (including primarily for concomitant conditions during ongoing SARS-CoV-2 infection)
• Anticipated transport to a different hospital or institution, in particular when such transport is anticipated for pending ECMO or RRT treatment
• Patients who cannot take drugs orally
• Allergic or hypersensitive to the IMP or any of the ingredients
• Use of the following concomitant medications is prohibited from Screening to end of treatment with IMP in this trial (up to Day 14) if not indicated otherwise in this protocol:
• Concurrent use of any mycophenolate mofetil or of methotrexate exceeding 17.5 mg weekly
• Any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid

Sponsors & Collaborators

• Immunic AG: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (4)

Military Medical Academy, Clinic of Infectious Diseases

Sofia, 1606, Bulgaria

Location

UMHATEM N.I.Pirogov, Clinic of internal diseases

Sofia, 1606, Bulgaria

Location

University Hospital Frankfurt, Infectious Diseases

Frankfurt, 60590, Germany

Location

Clinic of the Hannover Medical School, Pneumology Clinic

Hanover, 30625, Germany

Location

Related Publications (1)

• Vehreschild MJGT, Atanasov P, Yurko K, Oancea C, Popov G, Smesnoi V, Placinta G, Kohlhof H, Vitt D, Peelen E, Mihajlovic J, Muehler AR. Safety and Efficacy of Vidofludimus Calcium in Patients Hospitalized with COVID-19: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Infect Dis Ther. 2022 Dec;11(6):2159-2176. doi: 10.1007/s40121-022-00690-0. Epub 2022 Oct 15.

  PMID: 36242741 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Silke Kropp, Specialist Regulatory Operations & Systems
• Organization: Immunic AG

Silke.Kropp@imux.com

+49

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Trial participants, the investigator and all other personnel directly involved in the conduct of the trial will be blinded to treatment assignments. To maintain the blind, IMU-838 and placebo tablets will have identical appearance, shape and color, and will have identical labeling and packaging. To minimize the potential for bias, treatment randomization information will be kept confidential by the responsible personnel and will not be released to investigators, other trial center personnel, or the Sponsor's designee(s).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, randomized, parallel-group trial

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 7, 2020
• Study Start: June 11, 2020
• Primary Completion: January 12, 2021
• Study Completion: February 23, 2021
• Last Updated: November 13, 2024
• Results First Posted: November 13, 2024

Record last verified: 2024-10

Locations

DE (2); BU (2)