EUCTR2020-005849-16-BGActive, not recruitingPhase 1
An 8-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 development in hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) - Kinarus COVID-19 Study (KINETIC trial)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Kinarus AG
- Enrollment
- 432
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Diagnosis of COVID-19 confirmed by a positive test for SARS-CoV-2 RNA by RT PCR in a specimen from the upper respiratory tract, lower respiratory tract or expectorated sputum or by a positive rapid antigen test for SARS-CoV-2
- •2.Patients hospitalized due to symptomatic COVID-19 infection
- •a.with a WHO progression score of 4 presenting with at least one of the following co-morbidities: cardiac arrhythmia, arterial hypertension, coronary heart disease, adipositas, chronic renal disease, chronic hepatic disease, active cancer, asthma, COPD, , diabetes mellitus, history of cerebrovascular disease, autoimmune disease, immunosuppression or age > 60 years
- •b. with a WHO progression score of 5 with or without comorbidities
- •3. Patients being treated or having received off-label agents for COVID-19 (approved for another indication than COVID-19, such as dexamethasone or remdesivir) are eligible for the study
- •4. Adult male or female patients aged = 18 years
- •5. Females must have a negative pregnancy test or must be post-menopausal
- •6. Able to understand and willing to sign an IRB approved written informed consent document. For patients unable to understand and sign themselves, his/her legal representative will be informed and sings the informed consent document in countries where national law/regulations permit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 288
Exclusion Criteria
- •1. Patients participating in another clinical trial with a new investigational drug or an investigational non-drug treatment
- •2. Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
- •3. Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP
- •4. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
- •5. Any use of CYP450 2C8 inducers (e.g. rifampicin)
- •6. Known or suspected active viral (including HIV, hepatitis B, hepatitis C), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
- •7. Pregnant or breastfeeding women
- •8. Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator
- •9. Liver enzyme elevation more than 3x above normal
- •10.Patients who are detained or committed to an institution by a law court or by legal authorities (subject is vulnerable, such as deprived of freedom)
Investigators
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