Official Title
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
Brief Summary

The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explorethe efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo inCOVID-19 subjects in need of oxygen treatment.The target was to include forty (40) subjects with diagnosed COVID-19 for participationin the study. If at screening all criteria for study participation were fulfilled andinformed consent signed, the subject was enrolled and randomized into one of the twoarms. After randomization, the subjects were to receive KAND567 or placebo treatment for7 days.After the treatment period the subjects returned to ordinary clinical follow-up, but astudy follow-up visit was to be planned for Day 21 and 90.

Detailed Description

Not Provided

Terminated
COVID19

Drug: KAND567

2 x 125 mg capsules for oral administration. KAND567 (250 mg) was to be given every 12
hours for one week (7 days).

Drug: Microcrystalline cellulose

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).

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
Denmark
Sweden
Locations

Hvidovre Hospital
Hvidovre 2619528, Denmark

Odense University Hospital
Odense 2615876, Denmark

Capio St. Görans Hospital
Stockholm 2673730, Sweden

Västmanlands Hospital
Västerås 2664454, Sweden

Mantas Okas, MD, PhD, Principal Investigator
Capio St. Görans Hospital

Novakand Pharma AB
NCT Number
MeSH Terms
COVID-19
microcrystalline cellulose