MedTrace Logo

KAND567 Versus Placebo in Subjects Hospitalized With COVID-19

NCT06012565 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-25

No results posted yet for this study

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.

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

Interventions

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).

Sponsors & Collaborators

  • Novakand Pharma AB

    lead INDUSTRY

Principal Investigators

  • Mantas Okas, MD, PhD · Capio St. Görans Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2021-08-07
Completion
2021-08-07

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012565 on ClinicalTrials.gov