A 4-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 evolution and recovery in non-hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) - KIN001-204

Kinarus AG0 个研究点目标入组 440 人开始时间: 2022年4月19日最近更新: 2024年7月22日

研究概览

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•Diagnosis of symptomatic COVID-19 of less than 5 days’ duration, with at least 1 point in at least 4 items of the symptom evaluation table, and at least 2 points in at least 2 items, OR a minimum total score of 6 points (Table 1), Diagnosis of COVID-19 confirmed in the last 48 hours by a positive test for SARS-CoV-2 RNA by RT PCR or a rapid validated antigen test (excluding self-test), in a specimen from the upper respiratory tract, the saliva (antigen test), the lower respiratory tract or an expectorated sputum, No indication that the patient will be hospitalized in the next 48 hours for COVID-19 related reasons, Adult male or female patients aged = 18 years, Females must have a negative pregnancy test or must be post-menopausal, Able to understand and willing to sign an IRB/IEC approved written informed consent document., Able to understand and be available for daily phone calls to evaluate symptoms.

•Patients with an indication for hospitalization (e.g. SpO2 <92%), Liver enzyme elevation more than 3x above normal in the last 4weeks or at inclusion, Patients who are detained or committed to an institution by a lawcourt or by legal authorities (subject is vulnerable, such as deprived of freedom), Patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment, Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor, Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP., Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV),with hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria, Any use of CYP450 2C8 inducers (e.g. rifampicin), Known or suspected active viral (including HIV, hepatitis B, hepatitisC), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected., Pregnant or breastfeeding women, Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements as determined at the discretion of the investigator

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