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

NCT05659459 | Terminated Phase 2 DMC

• 1 other identifier: KIN001-204 - KIN-FAST
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• COVID-19 time to recovery

  28 days

• COVID-19 related hospital admissions

  28 days

• Safety and tolerability assessing treatment emergent adverse events

  28 days

• Total evaluation of COVID-10 symptoms score

  28 days

Other Outcomes (1)

• Exploratory outcome - Sars-CoV-2 positive familiy members

  10 days

Study Arms (2)

KIN001

EXPERIMENTAL

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

Drug: KIN001

Placebo

PLACEBO COMPARATOR

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

Drug: KIN001-Placebo

Interventions

KIN001 DRUG

Oral tablet

Also known as: Combination Pamapimod 75mg with Pioglitazone 5mg

KIN001

KIN001-Placebo DRUG

Comparator - Oral tablet with same appearance of KIN001

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Kinarus AG: lead

Study Sites (8)

Praxis am Ebertsplatz

Cologne, Germany

Location

Velocity Clinical Research Hamburg

Hamburg, Germany

Location

Praxis am Neckar

Heidelberg, Germany

Location

Hôpital de la Tour

Meyrin, Switzerland

Location

Cabinet Dr Clément

Nyon, Switzerland

Location

Cabinet Dr. Thanh

Nyon, Switzerland

Location

Cabinet Dr. Dang

Onex, Switzerland

Location

Cabinet Dr. Schaller

Onex, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 21, 2022
• Study Start: August 25, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); CH (5)