Clinical trial NCT05659459: The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) in Non Hospitalized Patients Infected With SARS-CoV-2
Official title: The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Kinarus AG
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.

Detailed description: 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.

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)

Primary outcomes:
measure: COVID-19 symptoms evaluation
timeFrame: 28 days
Secondary outcomes:
measure: COVID-19 time to recovery
timeFrame: 28 days
measure: COVID-19 related hospital admissions
timeFrame: 28 days
measure: Safety and tolerability assessing treatment emergent adverse events
timeFrame: 28 days
measure: Total evaluation of COVID-10 symptoms score
timeFrame: 28 days
Other outcomes:
measure: Exploratory outcome - Sars-CoV-2 positive familiy members
timeFrame: 10 days
Locations:
city: Cologne
country: Germany
facility: Praxis am Ebertsplatz
city: Hamburg
country: Germany
facility: Velocity Clinical Research Hamburg
city: Heidelberg
country: Germany
facility: Praxis am Neckar
city: Meyrin
country: Switzerland
facility: Hôpital de la Tour
city: Nyon
country: Switzerland
facility: Cabinet Dr Clément
city: Nyon
country: Switzerland
facility: Cabinet Dr. Thanh
city: Onex
country: Switzerland
facility: Cabinet Dr. Dang
city: Onex
country: Switzerland
facility: Cabinet Dr. Schaller
Study officials:
References: