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

Primary Purpose

COVID-19

Status
Suspended
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KIN001
KIN001-Placebo
Sponsored by
Kinarus AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Praxis am Ebertsplatz
  • Velocity Clinical Research Hamburg
  • Praxis am Neckar
  • Hôpital de la Tour
  • Cabinet Dr Clément
  • Cabinet Dr. Thanh
  • Cabinet Dr. Dang
  • Cabinet Dr. Schaller

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KIN001

Placebo

Arm Description

75mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days

75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
COVID-19 related hospital admissions
All-cause unplanned COVID-19 related hospital admissions
Safety and tolerability assessing treatment emergent adverse events
Safety and tolerability of KIN001
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

Full Information

First Posted
December 2, 2022
Last Updated
October 3, 2023
Sponsor
Kinarus AG
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1. Study Identification

Unique Protocol Identification Number
NCT05659459
Brief Title
The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) in Non Hospitalized Patients Infected With SARS-CoV-2
Acronym
KIN-FAST
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Sponsor has financial issues - trial currently on hold
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinarus AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KIN001
Arm Type
Experimental
Arm Description
75mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
KIN001
Other Intervention Name(s)
Combination Pamapimod 75mg with Pioglitazone 5mg
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
KIN001-Placebo
Intervention Description
Comparator - Oral tablet with same appearance of KIN001
Primary Outcome Measure Information:
Title
COVID-19 symptoms evaluation
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
COVID-19 time to recovery
Description
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
Time Frame
28 days
Title
COVID-19 related hospital admissions
Description
All-cause unplanned COVID-19 related hospital admissions
Time Frame
28 days
Title
Safety and tolerability assessing treatment emergent adverse events
Description
Safety and tolerability of KIN001
Time Frame
28 days
Title
Total evaluation of COVID-10 symptoms score
Description
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
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Exploratory outcome - Sars-CoV-2 positive familiy members
Description
Number of family members in the same household tested positive by Sars-CoV-2 PCR test two to 10 days after inclusion
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Praxis am Ebertsplatz
City
Cologne
Country
Germany
Facility Name
Velocity Clinical Research Hamburg
City
Hamburg
Country
Germany
Facility Name
Praxis am Neckar
City
Heidelberg
Country
Germany
Facility Name
Hôpital de la Tour
City
Meyrin
Country
Switzerland
Facility Name
Cabinet Dr Clément
City
Nyon
Country
Switzerland
Facility Name
Cabinet Dr. Thanh
City
Nyon
Country
Switzerland
Facility Name
Cabinet Dr. Dang
City
Onex
Country
Switzerland
Facility Name
Cabinet Dr. Schaller
City
Onex
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no IPD sharing plan

Learn more about this trial

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

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