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

NCT04708327 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: ST205-101-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who demonstrate progression of COVID-19 disease

  Progression of COVID-19 disease based on the WHO clinical progression scale (WHOb2020)

  Day 1 to Day 30

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dosing Period 1: Placebo (five capsules) Dosing Period 2: Placebo (one capsule)

Drug: STAT-205

STAT-205

EXPERIMENTAL

Dosing Period 1: 22.5 mg STAT-205 (five 4.5 mg capsules) Dosing Period 2: 4.5 mg STAT-205 (one capsule)

Drug: STAT-205

Interventions

STAT-205 DRUG

naltrexone hydrochloride capsules 4.5 mg each

Placebo; STAT-205

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 at the time of informed consent
• Able to understand and provide informed consent in either English or Spanish
• At high risk for COVID-19 disease progression by fulfilling at least ONE of the following criteria at Screening:
• Age ≥65 years
• Has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. COPD, chronic persistent asthma, cystic fibrosis, chronic bronchitis)
• Has a diagnosis of chronic heart disease
• Has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy
• Has hypertension requiring at least one oral medication for treatment
• Has a body mass index (BMI) of ≥33 kg/m2
• Has an immunocompromising disease (e.g. HIV infection with CD4 count \< 200 cells/mm3)
• Is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent
• Has received a solid organ transplant
• Has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of COVID-19
• Documentation of positive diagnostic test for SARS-CoV-2 (confirmed by PCR assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the Screening visit.
• Is symptomatic for COVID-19 for no more than 7 days prior to the Screening visit

You may not qualify if:

• Has a WHO Clinical Progression Scale (WHOb 2020) score of '4' or higher at Screening or Enrollment
• Previous hypersensitivity or allergic reactions to naltrexone
• Women who are pregnant or lactating or expecting to become pregnant
• Drugs of abuse screen positive for opiates
• Patients with history of moderate to severe renal impairment (estimated creatinine clearance \< 50 mL/min) or hepatic impairment (Child-Pugh C)
• Serum ALT or AST value \> 3 times the ULN at Screening
• Serum creatinine value \> 2 times the ULN at Screening, or requires renal dialysis
• Hematology results at Screening showing any one of the following: WBC \<2000 cells/mm3 or platelet count \<100,000 cells/mm3 or hemoglobin \<8.5 Gm/dL
• Currently receiving chronic daily opioid therapy
• Use of tocilizumab or other immunomodulator therapy directed to treatment or prevention of COVID-19
• History of active substance abuse within the 2 years prior to Screening
• Participation in another clinical trial investigating a treatment for COVID-19
• Currently hospitalized or under immediate consideration for hospitalization (for any medical reason) at the Screening visit
• At Screening, has new onset of dyspnea (shortness of breath) or, if previously diagnosed with a chronic lung condition, the severity of dyspnea has increased over patient's historical baseline condition (increased dyspnea should be present continually and not intermittent)
• Measurement of oxygen saturation at Screening is \< 94% on ambient room air

Sponsors & Collaborators

• Cytocom, Inc.: lead

Study Sites (2)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• George Azar, MD

  Clinical Research Center of Florida

  PRINCIPAL INVESTIGATOR

• Jennifer Veltman, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Louro

CONTACT

1-888-629-4155; dawn.louro@staterbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: December 5, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)