NCT04843787

SLV213 Treatment in Ambulatory COVID-19 Patients

A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Phase 2a Study of SLV213 in Ambulatory Individuals Positive for COVID-19

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Kenneth Krantz, MD, PhD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2a trial recruits adult ambulatory patients who have been determined to be COVID-19 positive. The study drug SLV213 will be administered to examine its safety, tolerability and provide assessment of its effect on clinical symptoms of COVID-19. Blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) analysis.

Detailed description

This double blind, placebo-controlled study will be conducted in two parts. Part A will determine the maximum tolerated dose (MTD) that will be used in Part B to confirm tolerance and provide assessment of the effect of SLV213 on clinical symptoms of COVID-19. Part A will consist of three sequential cohorts of 12 subjects receiving treatment administered orally either twice a day or once a day for seven consecutive days. Subjects in each cohort will be randomized to one of two treatment arms, SLV213 (8 subjects) or placebo (4 subjects). After each cohort, a Selva Safety Review Committee (SRC) will evaluate the safety of the regimen before proceeding to dose the next cohort. If a cohort is deemed to have reached an intolerable dose level, the dose prior to that level will be the MTD. PK blood samples will be collected throughout the study. In Part B of the study 45 subjects will be dosed at the MTD (30 SLV213 and 15 Placebo) to confirm tolerance, and to provide assessment of the effect of SLV213 on clinical symptoms of COVID-19. PK blood samples will be collected throughout the study.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	SLV213	SLV213 oral capsule (200mg) BID
DRUG	SLV213	SLV213 oral capsule (400mg) BID
DRUG	SLV213	SLV213 oral capsule (800mg) QD
DRUG	Placebo	Placebo oral capsule (200mg) BID
DRUG	Placebo	Placebo oral capsule (400mg) BID
DRUG	Placebo	Placebo oral capsule (800mg) QD

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2021-04-14
• Last updated: 2023-04-12

Regulatory

• FDA-regulated drug study