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Immunomodulator

STAT-205 for COVID-19

Phase 1
Waitlist Available
Led By George Azar, MD
Research Sponsored by Cytocom, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a diagnosis of chronic heart disease
Has hypertension requiring at least one oral medication for treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 30
Awards & highlights

Study Summary

This trial is testing if an experimental drug can help people with mild COVID-19 who are at high risk for disease progression.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who demonstrate progression of COVID-19 disease

Side effects data

From 2019 Phase 2 trial • 29 Patients • NCT03008590
7%
Dizziness
3%
Infections, minor viral or bacterial
3%
Ankle injury
3%
Fatigue
3%
Lip and tongue swelling
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
During Placebo Treatment
During Naltrexone Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: STAT-205Experimental Treatment1 Intervention
Dosing Period 1: 22.5 mg STAT-205 (five 4.5 mg capsules) Dosing Period 2: 4.5 mg STAT-205 (one capsule)
Group II: PlaceboPlacebo Group1 Intervention
Dosing Period 1: Placebo (five capsules) Dosing Period 2: Placebo (one capsule)

Find a Location

Who is running the clinical trial?

Cytocom, Inc.Lead Sponsor
George Azar, MDPrincipal InvestigatorClinical Research Center of Florida
Jennifer Veltman, MDPrincipal InvestigatorLoma Linda University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025