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

Study Overview
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Brief Summary
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Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.

Detailed Description
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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.

Official Title
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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)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: KIN001
* Drug: KIN001-Placebo


Participation Criteria
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Eligibility Criteria
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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. 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 Liver enzyme elevation more than 3x above normal in the last 4 weeks or at inclusion 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KIN001<br>75mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days | Drug: KIN001<br>* Oral tablet<br>* Other names: Combination Pamapimod 75mg with Pioglitazone 5mg;|
| Placebo Comparator: Placebo<br>75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days | Drug: KIN001-Placebo<br>* Comparator - Oral tablet with same appearance of KIN001<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 symptoms evaluation | Number of days alive with no score > 1 in each of the symptoms and a maximum of 3 points in the total score*, measured from inclusion to day 28 *Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 time to recovery | Time to clinical recovery, based on patient-reported daily evaluation of symptoms, and defined as the number of days from start of administration of the investigational agent to the first of two consecutive days when any symptoms scored as 2 or 3 at study entry are scored as 0-1 AND any symptoms scored as 0-1 at study entry are scored as 0 | 28 days | 
| COVID-19 related hospital admissions | All-cause unplanned COVID-19 related hospital admissions | 28 days | 
| Safety and tolerability assessing treatment emergent adverse events | Safety and tolerability of KIN001 | 28 days | 
| Total evaluation of COVID-10 symptoms score | Total sum of daily scores* of symptomes from inclusion to day 28 *Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs | 28 days |