SLV213 Treatment in Ambulatory COVID-19 Patients
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Agree to participate in the trial by signing the IRB approved Informed Consent
- Age ≥ 18 years of age
- Positive diagnosis for COVID-19 by SARS-CoV-2 PCR by nasopharyngeal swab within the past 3 days
- Two or more COVID-19 symptoms (at least one of which must be Respiratory) rated Mild or Moderate on the COVID-19 adapted FLU-PRO Plus scale
- SpO2 ≥ 94%
- Ambulatory (not hospitalized) at the time of enrollment
At increased risk of developing more severe COVID-19 disease (at least one of the following):
- Age ≥60 years
- Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema
- Diabetes mellitus (type 1 or 2), requiring oral medication or insulin for treatment
- Cardiovascular disease, including Hypertension, requiring at least 1 oral medication for treatment; congestive heart failure; coronary artery disease; cardiomyopathy; pulmonary hypertension
- Body mass index ≥30
- Chronic renal disease (but not on dialysis)
- Sickle cell disease or trait
- Comorbid disease (as above) well controlled/stable in opinion of the Investigator
- Normal (or stable if abnormal per comorbidity) baseline ECG
- Men of child-bearing potential must use birth control with heterosexual partner(s) (abstinence or condoms)
Women of child-bearing potential must meet all the following criteria:
- Use of birth control (abstinence, oral contraceptives, condoms, or intrauterine device)
- Test negative for β-subunit of HCG
Exclusion Criteria:
- Pregnant or lactating
- Treatment with COVID-19 antiviral such as remdesivir or SARS-CoV-2 antibodies
- Prior COVID-19 vaccination or prior recovery from documented COVID-19 infection
- Severe or Critical COVID-19, as indicated by respiratory distress or shortness of breath at rest; Resp Rate ≥30/min; Heart rate ≥125/min; SpO2 ≤ 93% on room air or PaO2/FiO2 ≤ 300 if on supplemental O2
- Positive HIV or positive Hepatitis Panel
- Treatment with any medications known to be strongly metabolized by CYP3A4 or CYP2D6
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental: Multiple Ascending Dose Cohort 1
Placebo Comparator: Multiple Ascending Dose Cohort 1
Experimental: Multiple Ascending Dose Cohort 2
Placebo Comparator: Multiple Ascending Dose Cohort 2
Experimental: Multiple Ascending Dose Cohort 3
Placebo Comparator: Multiple Ascending Dose Cohort 3
Experimental: Multiple Ascending Dose Cohort 4
Placebo Comparator: Multiple Ascending Dose Cohort 4
Intervention: SLV213, 8 subjects will receive 200mg oral doses twice a day for seven consecutive days.
Intervention: Placebo, 4 subjects will receive an equivalent number of oral doses twice a day for seven consecutive days.
Intervention: SLV213, 8 subjects will receive 400mg oral doses twice a day for seven consecutive days.
Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses twice a day for seven consecutive days.
Intervention: SLV213, 8 subjects will receive 800mg oral doses once a day for seven consecutive days.
Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses once a day for seven consecutive days.
Intervention: SLV213, 30 subjects will receive the MTD (200mg twice a day, 400mg twice a day or 800 mg once a day) oral doses for seven consecutive days.
Intervention: Placebo, 15 subjects will receive the equivalent number of oral doses once a day or twice a day for seven consecutive days.