NCT06012565

KAND567 Versus Placebo in Subjects Hospitalized With COVID-19

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Novakand Pharma AB · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2020-10-11
• Primary completion: 2021-08-07
• Completion: 2021-08-07
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

4 sites across 2 countries: Denmark, Sweden