Clinical trial: Phase 2 Trial to Evaluate Safety and Efficacy of CYTO-205 in Mild COVID-19 (NCT04708327)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction