- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012565
KAND567 Versus Placebo in Subjects Hospitalized With COVID-19
KAND567 Versus Placebo in Subjects Hospitalized With COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics
The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explore the efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo in COVID-19 subjects in need of oxygen treatment.
The target was to include forty (40) subjects with diagnosed COVID-19 for participation in the study. If at screening all criteria for study participation were fulfilled and informed consent signed, the subject was enrolled and randomized into one of the two arms. After randomization, the subjects were to receive KAND567 or placebo treatment for 7 days.
After the treatment period the subjects returned to ordinary clinical follow-up, but a study follow-up visit was to be planned for Day 21 and 90.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written Informed Consent obtained and documented according to national/local regulations prior to any study-specific procedure.
- Males and females aged ≥18-85 years at the time of signing the informed consent form.
- Patients with symptoms and signs of SARS-CoV-2 infection according to the World Health Organization (WHO) case definition. Symptoms must include shortness of breath, with an onset which occurred ≤ 10 days before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of ≥ 92%, and at least one of the following laboratory values:
(A) Ferritin: > 300 ng/mL for men and > 150 ng/mL for women. (B) C-reactive protein (CRP): ≥ 10 mg/L. (C) D-dimer elevated above the age-adjusted lower limit: (i) ≤ 50 years; < 0.5 mg/L FEU (Fibrinogen Equivalent Units). (ii) > 50 years; age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e., one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU; one who is 90 years old has a reference limit of < 0.9 mg/L FEU).
- Able to swallow capsules
- Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP). Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy.
- Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.
Exclusion Criteria:
- Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation; or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation.
- A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19).
- Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease.
- Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Clinically verified pulmonary embolism
- Chronic use of oral corticosteroids for treatment of inflammatory disease
- Use of strong CYP3A4 inhibitors (e.g., azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g., rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g., benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]).
- Participation in another pharmaceutical clinical study.
- Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP).
- Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or Intensive Care Unit (ICU) admission for any other cause than respiratory support.
- Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons.
- Active malignancy with or without treatment, except local basal cell carcinoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Capsules for oral administration, consisting of microcrystalline cellulose oral solid formulation in capsules.
Placebo was to be given every 12 hours for one week (7 days).
|
Experimental: KAND567
|
2 x 125 mg capsules for oral administration.
KAND567 (250 mg) was to be given every 12 hours for one week (7 days).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of KAND567, as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs).
Time Frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 90).
|
From the first IMP administration (Day 1) until the last follow-up visit (Day 90).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mantas Okas, MD, PhD, Capio St. Görans Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAN0006
- 2020-002322-85 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on KAND567
-
Kancera ABCompleted
-
Kancera ABNordic Society of Gynaecological Oncology - Clinical Trials UnitRecruitingFallopian Tube Cancer | Epithelial Ovarian Cancer | Peritoneal CancerDenmark, Norway, Sweden