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
Trial Information
Current as of January 16, 2025
Suspended
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)
About Kinarus Ag
Kinarus AG is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for respiratory and infectious diseases. Leveraging a robust pipeline, Kinarus aims to address unmet medical needs through novel drug formulations and repurposed therapies, emphasizing safety and efficacy. With a commitment to scientific excellence and patient-centric solutions, Kinarus collaborates with leading research institutions and healthcare professionals to advance its clinical trials and contribute to the global healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Meyrin, , Switzerland
Cologne, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Nyon, , Switzerland
Nyon, , Switzerland
Onex, , Switzerland
Onex, , Switzerland
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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