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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708327
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Cytocom, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: STAT-205 Phase 1

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 QD, to be followed by a second dosing period (period 2) of 4.5 mg QD to complete 30 days of dosing. Patients randomized to placebo will receive placebo QD. Blood samples for pharmacokinetic analysis and measurement of inflammatory biomarkers will be collected from patients on day 1, day 6, day 15 and day 30. Patients will be seen in the clinic on days 1, 6, 15, and 30. Patients will be contacted via telephone for follow up on day 60 and on. each post treatment day through Day 60. The telephone visit should occur at approximately the same time each day. During the telephone visits, the presence and severity of COVID-19 symptoms that were recorded at Baseline will be queried, and any new symptoms will be recorded. During the daily telephone visits, patients will also be queried for any adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Randomized, Single-Blind Study to Evaluate the Pharmacokinetics, Biomarkers, Safety and Tolerability of STAT-205 in Adult Patients With Mild COVID 19 Who Are at High Risk of Disease Progression
Actual Study Start Date : December 5, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Dosing Period 1: Placebo (five capsules) Dosing Period 2: Placebo (one capsule)
Drug: STAT-205
naltrexone hydrochloride capsules 4.5 mg each

Experimental: STAT-205
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
naltrexone hydrochloride capsules 4.5 mg each




Primary Outcome Measures :
  1. Proportion of patients who demonstrate progression of COVID-19 disease [ Time Frame: Day 1 to Day 30 ]
    Progression of COVID-19 disease based on the WHO clinical progression scale (WHOb2020)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 at the time of informed consent
  2. Able to understand and provide informed consent in either English or Spanish
  3. At high risk for COVID-19 disease progression by fulfilling at least ONE of the following criteria at Screening:

    1. Age ≥65 years
    2. Has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. COPD, chronic persistent asthma, cystic fibrosis, chronic bronchitis)
    3. Has a diagnosis of chronic heart disease
    4. Has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy
    5. Has hypertension requiring at least one oral medication for treatment
    6. Has a body mass index (BMI) of ≥33 kg/m2
    7. Has an immunocompromising disease (e.g. HIV infection with CD4 count < 200 cells/mm3)
    8. Is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent
    9. Has received a solid organ transplant
    10. Has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of COVID-19
  4. 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.
  5. Is symptomatic for COVID-19 for no more than 7 days prior to the Screening visit
  6. Has a WHO Clinical Progression Scale (WHOb 2020) score of either '2' or '3' at Screening and Randomization
  7. 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

  8. 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:

    1. Oral or injectable contraceptive and condom, or
    2. IUD and condom, or
    3. Diaphragm with spermicide and condom.
  9. 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 Criteria:

  1. Has a WHO Clinical Progression Scale (WHOb 2020) score of '4' or higher at Screening or Enrollment
  2. Previous hypersensitivity or allergic reactions to naltrexone
  3. Women who are pregnant or lactating or expecting to become pregnant
  4. Drugs of abuse screen positive for opiates
  5. Patients with history of moderate to severe renal impairment (estimated creatinine clearance < 50 mL/min) or hepatic impairment (Child-Pugh C)
  6. Serum ALT or AST value > 3 times the ULN at Screening
  7. Serum creatinine value > 2 times the ULN at Screening, or requires renal dialysis
  8. 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
  9. Currently receiving chronic daily opioid therapy
  10. Use of tocilizumab or other immunomodulator therapy directed to treatment or prevention of COVID-19
  11. History of active substance abuse within the 2 years prior to Screening
  12. Participation in another clinical trial investigating a treatment for COVID-19
  13. Currently hospitalized or under immediate consideration for hospitalization (for any medical reason) at the Screening visit
  14. 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)
  15. Measurement of oxygen saturation at Screening is < 94% on ambient room air
  16. Shares a household with a patient currently enrolled in this protocol
  17. Patients who refuse biomarker blood draws

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708327


Contacts
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Contact: Dawn Louro 1-888-629-4155 ext 147 dawn.louro@staterbiopharma.com

Locations
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United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Contact: Danielle Gincastro    909-558-7427    dgincastro@llu.edu   
Principal Investigator: Jennifer Veltman, MD         
United States, Florida
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Jordan Herman, CCRC    954-941-3330    jordan@floridacr.com   
Principal Investigator: George Azar, MD         
Sponsors and Collaborators
Cytocom, Inc.
Investigators
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Principal Investigator: George Azar, MD Clinical Research Center of Florida
Principal Investigator: Jennifer Veltman, MD Loma Linda University
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Responsible Party: Cytocom, Inc.
ClinicalTrials.gov Identifier: NCT04708327    
Other Study ID Numbers: ST205-101-002
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases