Phase 2 Trial to Evaluate Safety and Efficacy of CYTO-205 in Mild COVID-19
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ClinicalTrials.gov Identifier: NCT04708327 |
Recruitment Status :
Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
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This is a randomized, double-blind, placebo-controlled study. The aim of the study is to assess the safety and clinical efficacy of low-dose naltrexone in reducing the proportion of higher risk patients who progress from mild COVID-19 to a more severe disease category.
Male and female participants with a confirmed positive SARS-CoV-2 diagnostic test at screening, who are symptomatic with mild COVID-19 (as measured by WHO clinical progression scale, WHOb 2020) and are at high risk for COVID-19 progression will be enrolled. High risk is based on presence of one or more criteria which could include age ≥65 years, increased BMI ≥33 kg/m2, or the presence of certain comorbidities (refer to Section 4 for complete eligibility criteria).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: Naltrexone Hydrochloride | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | double-blind |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-controlled, Phase 2 Study to Evaluate Safety and Efficacy of CYTO-205 (Low-dose Naltrexone) in Adult Patients With Mild COVID-19 Infection Who Are at High Risk for Disease Progression |
Estimated Study Start Date : | April 2021 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Naltrexone Hydrochloride
naltrexone hydrochloride capsules 4.5 mg each |
Experimental: CYTO-205 22.5 mg |
Drug: Naltrexone Hydrochloride
naltrexone hydrochloride capsules 4.5 mg each |
Experimental: CYTO-205 45 mg |
Drug: Naltrexone Hydrochloride
naltrexone hydrochloride capsules 4.5 mg each |
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 at the time of informed consent
- Able to understand and provide informed consent in either English or Spanish
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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
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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 Criteria:
- 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
Responsible Party: | Cytocom, Inc. |
ClinicalTrials.gov Identifier: | NCT04708327 |
Other Study ID Numbers: |
CYTO-001 |
First Posted: | January 13, 2021 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Naltrexone Alcohol Deterrents Narcotic Antagonists |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |