COVID-19Phase 1NCT04708327
Single-Blind Study of STAT-205 in Mild COVID-19
A Phase 1 study testing STAT-205 in people with COVID-19, run by Cytocom, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- STAT-205
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2021to 30 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Danielle Gincastro, 909-558-7427, dgincastro@llu.edu
Jennifer Veltman, MD
- Recruiting
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Jordan Herman, CCRC, 954-941-3330, jordan@floridacr.com
George Azar, MD
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- STAT-205
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAT-205Drug
naltrexone hydrochloride capsules 4.5 mg each
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dosing Period 1: Placebo (five capsules) Dosing Period 2: Placebo (one capsule) Receives: 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) Receives: Drug: STAT-205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who demonstrate progression of COVID-19 disease
Progression of COVID-19 disease based on the WHO clinical progression scale (WHOb2020)
Measured: Day 1 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start5 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytocom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Azar, MD, Principal investigator, Clinical Research Center of FloridaJennifer Veltman, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708327
- Sponsor's protocol ID
- ST205-101-002
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04708327
- Acronym / sponsor ID
- ST205-101-002
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cytocom, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: STAT-205Dosing Period 1: Placebo (five capsules) Dosing Period 2: Placebo (one capsule) |
| STAT-205 | Experimental | Drug: STAT-205Dosing Period 1: 22.5 mg STAT-205 (five 4.5 mg capsules) Dosing Period 2: 4.5 mg STAT-205 (one capsule) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAT-205naltrexone hydrochloride capsules 4.5 mg each | Drug | Placebo, STAT-205 |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Azar, MD principal investigator
Clinical Research Center of Florida
Jennifer Veltman, MD principal investigator
Loma Linda University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STAT-205 in people with COVID-19, run by Cytocom, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn Louro (1-888-629-4155 ext. 147, dawn.louro@staterbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who demonstrate progression of COVID-19 disease (time frame: Day 1 to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.