COVID-19 development in hospitalized patients infected with SARS-CoV-2 MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862
Conditions
Sponsors
Kinarus AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 or 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the percentage of participants who die or require non-invasive ventilation / high flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation (ECMO)) measured in the time frame from Day 0 to week 4 * * the indication for non-invasive ventilation or high-flow oxygen or invasive mechanical ventilation or ECMO is based on the judgement of the investigator. This includes patients qualifying for any of these therapies but not receiving it for reasons unrelated to the indication, e.g. patient refuses intubation, high-flow or mechanical ventilation or ECMO not available, general condition of patient too bad, etc. ;Secondary Objective: The secondary objectives for this study are: • Number of ventilator-free days (invasive mechanical ventilation) measured in the time fram from Day 0 to week 4 • Number of invasive, high flow oxygenation, non invasive ventilation and ECMO free days measured in the time frame of Day 0 to week 4 • To evaluate the reduction in mortality or severe respiratory failure as determined by need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/o ECMO until end of the study (measured at 8 weeks • To evaluate the all cause mortality measured at 4 and 8 weeks) • To evaluate the reduction in severe respiratory failure rate as defined by need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/or ECMO (by number of patients) at 4 weeks and end of study¬ (8 weeks) • To evaluate the safety and tolerability of pamapimod used in combination with pioglitazone • To determine length of hospitalization / ICU stay ;Primary end point(s): Percentage of Participants who die or require non-invasive ventilation / high-flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation (ECMO)) measured in the time frame from Day 0 to week 4;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of ventilator-free days (invasive mechanical ventilation) measured in the time frame from D0 to week 4 • Number of invasive ventilation, high-flow oxygenation, non invasive ventilation, and ECMO free days measured in the time frame of Day 0 to week 4 • Reduction in mortality or severe respiratory failure as determined by need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/or ECMO until end of study (measured at 8 weeks) • All cause mortality by end of study (measured at 4 and 8 weeks) • Reduction in severe respiratory failure rate as defined by the need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/or ECMO at 4 weeks and end of study (8 weeks) • Safety and tolerability of pamapimod used in combination with pioglitazone • Length of hospitalization • Length of ICU stay • Days free of invasive mechanical ventilation at 4 and 8 weeks • Total days free of any oxygen supplementation at 4 and 8 weeks • Clinical Status on Baseline, days 4, 7 and 14 and week 4 and 8 measured by the nine point WHO COVID-19 clinical progression score and EQ5D;Timepoint(s) of evaluation of this end point: 8 weeks / 4 weeks | — |
Countries
Argentina, Bulgaria, Germany, Hungary, Poland, Romania, Russian Federation
Contacts
Public ContactHead Project Management
Kinarus AG
Outcome results
None listed