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

NCT ID: NCT05659459

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2023-10-01

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KIN001

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

Group Type: EXPERIMENTAL

KIN001

Intervention Type: DRUG

Oral tablet

Placebo

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

Group Type: PLACEBO_COMPARATOR

KIN001-Placebo

Intervention Type: DRUG

Comparator - Oral tablet with same appearance of KIN001

Interventions

KIN001

Oral tablet

Intervention Type: DRUG

KIN001-Placebo

Comparator - Oral tablet with same appearance of KIN001

Intervention Type: DRUG

Other Intervention Names

Combination Pamapimod 75mg with Pioglitazone 5mg

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinarus AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Praxis am Ebertsplatz

Cologne, , Germany

Velocity Clinical Research Hamburg

Hamburg, , Germany

Praxis am Neckar

Heidelberg, , Germany

Hôpital de la Tour

Meyrin, , Switzerland

Cabinet Dr Clément

Nyon, , Switzerland

Cabinet Dr. Thanh

Nyon, , Switzerland

Cabinet Dr. Dang

Onex, , Switzerland

Cabinet Dr. Schaller

Onex, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

KIN001-204 - KIN-FAST

Identifier Type: -

Identifier Source: org_study_id