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.

Phase 1

• Conditions: Acute respiratory distress syndrome (ARDS) in COVID-19 infection; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002322-85-SE
• Lead Sponsor: Kancera AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure.
2.Males and females aged =18-85 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. 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).
* Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion, vasectomy, sexual abstinence
3.Patients with symptoms and signs of SARS-CoV-2 infection according to 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
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; on who is 90 years old has a reference limit of < 0.9 mg/L FEU)
4.Able to swallow capsules.
5.Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1.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.
2.A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19).
3.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.
4.Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure.
5.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.
6.Clinically verified pulmonary embolism
7.Chronic inflammatory disease requiring treatment with oral corticosteroids in a dose higher than prednisone 10 milligrams (mg) or equivalent per day, or requiring treatment with other anti-inflammatory drugs (e.g. methotrexate).
8.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]).
9.Participation in another pharmaceutical clinical study.
10.Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP).
11.Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support.
12.Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons.
13.Active malignancy with or without treatment, except local basal cell carcinoma.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified