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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05659459
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Kinarus AG

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: KIN001 Drug: KIN001-Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 25, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: KIN001
75mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days
 Drug: KIN001
Oral tablet
Other Name: Combination Pamapimod 75mg with Pioglitazone 5mg
Placebo Comparator: Placebo
75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days
 Drug: KIN001-Placebo
Comparator - Oral tablet with same appearance of KIN001


Outcome Measures
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Primary Outcome Measures :
  1. COVID-19 symptoms evaluation [ Time Frame: 28 days ]

    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 :
  1. COVID-19 time to recovery [ Time Frame: 28 days ]
    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

  2. COVID-19 related hospital admissions [ Time Frame: 28 days ]
    All-cause unplanned COVID-19 related hospital admissions

  3. Safety and tolerability assessing treatment emergent adverse events [ Time Frame: 28 days ]
    Safety and tolerability of KIN001

  4. Total evaluation of COVID-10 symptoms score [ Time Frame: 28 days ]

    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



Other Outcome Measures:
  1. Exploratory outcome - Sars-CoV-2 positive familiy members [ Time Frame: 10 days ]
    Number of family members in the same household tested positive by Sars-CoV-2 PCR test two to 10 days after inclusion


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05659459


Contacts
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Contact: Claudia Berger, PhD +41 61 633 29 71 info@kinarus.com

Locations
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Germany
Praxis am Ebertsplatz Recruiting
Cologne, Germany
Contact: Christoph Wyen         
Velocity Clinical Research Hamburg Recruiting
Hamburg, Germany
Contact: René Martz         
Praxis am Neckar Recruiting
Heidelberg, Germany
Contact: Andreas Horn         
Switzerland
Hôpital de la Tour Recruiting
Meyrin, Switzerland
Contact: Omar Kherad         
Cabinet Dr Clément Recruiting
Nyon, Switzerland
Contact: Serge Clément, MD         
Cabinet Dr. Thanh Recruiting
Nyon, Switzerland
Contact: Phan Thanh, MD         
Cabinet Dr. Dang Recruiting
Onex, Switzerland
Contact: Thanh Dang, MD         
Cabinet Dr. Schaller Recruiting
Onex, Switzerland
Contact: Dorian Schaller, MD         
Sponsors and Collaborators
Kinarus AG
More Information
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Responsible Party: Kinarus AG
ClinicalTrials.gov Identifier: NCT05659459    
Other Study ID Numbers: KIN001-204 - KIN-FAST
First Posted: December 21, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD sharing plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs