Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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.
Exclusion criteria
✕. Patients with an indication for hospitalization (e.g. SpO2 \<92%)
✕. 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, hepatitis C), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.