Status:
UNKNOWN
Single-Blind Study of STAT-205 in Mild COVID-19
Lead Sponsor:
Cytocom, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
Eligible patients will be randomized, 1:2, to either placebo or STAT-205. Randomization will be stratified by site. STAT-205 treatment will include an initial 5-day dosing period (period 1) of 22.5 mg...
Eligibility Criteria
Inclusion
- 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
- Has a WHO Clinical Progression Scale (WHOb 2020) score of either '2' or '3' at Screening and Randomization
- Has at least one of the following symptoms at the Screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to Screening:
- · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia
- If female of child-bearing potential, must agree to use of 2 forms of contraception from Screening to end of the study. Males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. Acceptable methods of birth control which must be used together are:
- Oral or injectable contraceptive and condom, or
- IUD and condom, or
- Diaphragm with spermicide and condom.
- Agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.
Exclusion
- 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
- Shares a household with a patient currently enrolled in this protocol
- Patients who refuse biomarker blood draws
Key Trial Info
Start Date :
December 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04708327
Start Date
December 5 2021
End Date
September 30 2022
Last Update
December 22 2021
Active Locations (2)
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1
Loma Linda University
Loma Linda, California, United States, 92354
2
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060