Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Oral tablet
Comparator - Oral tablet with same appearance of KIN001
Praxis am Ebertsplatz
Cologne, Germany
Velocity Clinical Research Hamburg
Hamburg, Germany
Praxis am Neckar
Heidelberg, Germany
Hôpital de la Tour
Meyrin, Switzerland
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
Time frame: 28 days
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
Time frame: 28 days
COVID-19 related hospital admissions
All-cause unplanned COVID-19 related hospital admissions
Time frame: 28 days
Safety and tolerability assessing treatment emergent adverse events
Safety and tolerability of KIN001
Time frame: 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
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cabinet Dr Clément
Nyon, Switzerland
Cabinet Dr. Thanh
Nyon, Switzerland
Cabinet Dr. Dang
Onex, Switzerland
Cabinet Dr. Schaller
Onex, Switzerland