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SLV213 Treatment in Ambulatory COVID-19 Patients

NCT04843787 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-04-12

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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

Sponsors & Collaborators

  • FHI Clinical, Inc.

    collaborator UNKNOWN

  • Kenneth Krantz, MD, PhD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-06-01
Completion
2024-07-01
FDA Drug
Yes

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Entities

Drugs

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 NCT04843787 on ClinicalTrials.gov