COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005849-16/DE

Kinarus AG - Head Project Management

corinne.peter@kinarus.com

2020-12-18

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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)

2

Kinarus AG

18

100

Argentina;Poland;Bulgaria;Romania;Hungary;Russia;Switzerland

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

30

Percentage of Participants who are alive and do not require any oxygen or respiratory support* (conventional oxygen therapy, highflow nasal canula oxygen therapy, non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)) during the full 28-day period (D0 to D28)* *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.

nan

Phase 2

[{"arm_notes": "", "treatment_id": 1661, "treatment_name": "Pamapimod+pioglitazone", "treatment_type": "Kinase inhibitors+metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]