Covid19Phase 2NCT06012565
KAND567 Versus Placebo in Subjects Hospitalized With COVID-19
A Phase 2 study testing KAND567 and Microcrystalline cellulose in people with Covid19, run by Novakand Pharma AB at 4 sites in 2 countries.
Trial 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 of oxygen treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19
- What is being tested?
- KAND567 and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Oct 2020to 7 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark2 sites
Hvidovre Hospital
Hvidovre, 2650
Odense University Hospital
Odense, 5000
Sweden2 sites
Capio St. Görans Hospital
Stockholm, 11281
Västmanlands Hospital
Västerås, 721 89
About this study
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
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.
- Conditions
- Covid19
- Being tested
- KAND567, Microcrystalline cellulose
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAND567Drug
2 x 125 mg capsules for oral administration. KAND567 (250 mg) was to be given every 12 hours for one week (7 days).
Microcrystalline celluloseDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| KAND567 | Experimental | Not described Receives: Drug: KAND567 |
| Placebo | Placebo comparator | Not described Receives: Drug: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of KAND567, as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs).
Measured: From the first IMP administration (Day 1) until the last follow-up visit (Day 90).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start11 Oct 2020
- Primary completion7 Aug 2021
- Study completion7 Aug 2021
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novakand Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mantas Okas, MD, PhD, Principal investigator, Capio St. Görans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012565
- Sponsor's protocol ID
- KAN0006
- Other IDs
- 2020-002322-85
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06012565
- Acronym / sponsor ID
- KAN0006
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novakand Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 7 Aug 2021 (actual)
- Study completion
- 7 Aug 2021 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAND567 | Experimental | Drug: KAND567 |
| Placebo | Placebo comparator | Drug: Microcrystalline cellulose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAND5672 x 125 mg capsules for oral administration. KAND567 (250 mg) was to be given every 12 hours for one week (7 days). | Drug | KAND567 |
| Microcrystalline celluloseCapsules 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). | Drug | Placebo |
Primary outcome
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).
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mantas Okas, MD, PhD principal investigator
Capio St. Görans Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAND567 and Microcrystalline cellulose in people with Covid19, run by Novakand Pharma AB at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.