Status:
TERMINATED
KAND567 Versus Placebo in Subjects Hospitalized With COVID-19
Lead Sponsor:
Novakand Pharma AB
Conditions:
Covid19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06012565
Start Date
October 11 2020
End Date
August 7 2021
Last Update
August 25 2023
Active Locations (4)
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1
Hvidovre Hospital
Hvidovre, Denmark, 2650
2
Odense University Hospital
Odense, Denmark, 5000
3
Capio St. Görans Hospital
Stockholm, Sweden, 11281
4
Västmanlands Hospital
Västerås, Sweden, 721 89