COVID-19Phase 2KIN-FASTNCT05659459
The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) in Non Hospitalized Patients Infected With SARS-CoV-2
A Phase 2 study testing KIN001 in people with COVID-19, run by Kinarus AG at 8 sites in 2 countries.
Trial summary
Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- KIN001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Aug 2022to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Switzerland5 sites
Hôpital de la Tour
Meyrin
Cabinet Dr Clément
Nyon
Cabinet Dr. Thanh
Nyon
Cabinet Dr. Dang
Onex
Cabinet Dr. Schaller
Onex
Germany3 sites
Praxis am Ebertsplatz
Cologne
Velocity Clinical Research Hamburg
Hamburg
Praxis am Neckar
Heidelberg
About this study
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)
Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.
Read the 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
- Being tested
- KIN001, KIN001-Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIN001Drug
Also called Combination Pamapimod 75mg with Pioglitazone 5mg
Oral tablet
KIN001-PlaceboDrug
Comparator - Oral tablet with same appearance of KIN001
| Study group | Role | What they receive |
|---|---|---|
| KIN001 | Experimental | 75mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days Receives: Drug: KIN001 |
| Placebo | Placebo comparator | 75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days Receives: Drug: KIN001-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (4)
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
Measured: 28 days
COVID-19 related hospital admissions
All-cause unplanned COVID-19 related hospital admissions
Measured: 28 days
Safety and tolerability assessing treatment emergent adverse events
Safety and tolerability of KIN001
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start25 Aug 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Sponsor went bankrupt - trial was discontinued due to lack of financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinarus AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659459
- Sponsor's protocol ID
- KIN001-204 - KIN-FAST
- Acronym
- KIN-FAST
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05659459
- Acronym / sponsor ID
- KIN-FAST / KIN001-204 - KIN-FAST
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor went bankrupt - trial was discontinued due to lack of financing
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kinarus AGIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIN001 | Experimental | Drug: KIN00175mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days |
| Placebo | Placebo comparator | Drug: KIN001-Placebo75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIN001Also: Combination Pamapimod 75mg with Pioglitazone 5mgOral tablet | Drug | KIN001 |
| KIN001-PlaceboComparator - Oral tablet with same appearance of KIN001 | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
COVID-19 time to recovery
Time frame: 28 days
COVID-19 related hospital admissions
Time frame: 28 days
Safety and tolerability assessing treatment emergent adverse events
Time frame: 28 days
Total evaluation of COVID-10 symptoms score
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Sponsor went bankrupt - trial was discontinued due to lack of financing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No. no IPD sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KIN001 in people with COVID-19, run by Kinarus AG at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor went bankrupt - trial was discontinued due to lack of financing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 symptoms evaluation (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.