MedTrace Logo

Single-Blind Study of STAT-205 in Mild COVID-19

NCT04708327 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-22

No results posted yet for this study

Summary

This is a randomized, single blind, study. Males and females meeting inclusion criteria who have symptoms of mild COVID-19 and in whom a positive PCR result for SARS-CoV-2 is obtained may be enrolled to the study treatment within 72 hours of the positive PCR result. Eligible patients are those considered to be at high risk for COVID-19 disease progression. This includes patients ≥ 65 years of age or with any one or more of certain medical conditions including: cancer, COPD, cardiovascular disease, immunocompromised state resulting from solid organ transplant, obesity, sickle cell disease, history of smoking, and diabetes.

Conditions

Interventions

DRUG

STAT-205

naltrexone hydrochloride capsules 4.5 mg each

Sponsors & Collaborators

  • Cytocom, Inc.

    lead INDUSTRY

Principal Investigators

  • George Azar, MD · Clinical Research Center of Florida

  • Jennifer Veltman, MD · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-05
Primary Completion
2022-06-30
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04708327 on ClinicalTrials.gov