The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) in Non Hospitalized Patients Infected With SARS-CoV-2

Launched by KINARUS AG · Dec 12, 2022

Keywords

ClinConnect Summary

This is a prospective, double-blind, randomized and placebo-controlled phase II trial to evaluate the safety and efficacy of KIN001 in non-hospitalized patients suffering from COVID-19. Randomization to one of two treatment arms (KIN001 versus Placebo) is at a ratio of 1:1.

Patients will receive treatment for 14 days and followed for another 14 days. The primary outcome is patient reported COVID-19 symptoms, using the FDA questionnaire developed for assessing COVID-19-related symptoms in outpatients.

The trial will be conducted in Switzerland and Germany.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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
• • 3. No indication that the patient will be hospitalized in the next 48 hours for COVID-19 related reasons
• • 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/IEC approved written informed consent document.
• • 7. Able to understand and be available for daily phone calls to evaluate symptoms.
• Exclusion Criteria:
• • 1. Patients with an indication for hospitalization (e.g. SpO2 \<92%)
• • 2. Patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment
• • 3. Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
• • 4. Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP.
• • 5. 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
• • 6. Any use of CYP450 2C8 inducers (e.g. rifampicin)
• • 7. 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.
• • 8. Pregnant or breastfeeding women
• • 9. 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
• • 10. Liver enzyme elevation more than 3x above normal in the last 4 weeks or at inclusion
• • 11. 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)