SLV213 Treatment in COVID-19 Patients

• Status: Not yet recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2a trial recruits adult ambulatory patients who have been determined to be COVID-19 positive. The study drug SLV213 will be administered to examine its safety, tolerability and provide assessment of its effect on clinical symptoms of COVID-19. Blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) analysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kenneth Krantz, MD, PhD
• Collaborator: FHI Clinical, Inc.

Criteria

Inclusion Criteria:

1. Agree to participate in the trial by signing the IRB approved Informed Consent

2. Age ≥ 18 years of age

3. Positive diagnosis for COVID-19 by SARS-CoV-2 PCR by nasopharyngeal swab within the past 3 days

4. 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

5. SpO2 ≥ 94%

6. Ambulatory (not hospitalized) at the time of enrollment

7. At increased risk of developing more severe COVID-19 disease (at least one of the following):

1. Age ≥60 years

2. Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema

3. Diabetes mellitus (type 1 or 2), requiring oral medication or insulin for treatment

4. Cardiovascular disease, including Hypertension, requiring at least 1 oral medication for treatment; congestive heart failure; coronary artery disease; cardiomyopathy; pulmonary hypertension

5. Body mass index ≥30

6. Chronic renal disease (but not on dialysis)

7. Sickle cell disease or trait

8. Comorbid disease (as above) well controlled/stable in opinion of the Investigator

9. Normal (or stable if abnormal per comorbidity) baseline ECG

10. Men of child-bearing potential must use birth control with heterosexual partner(s) (abstinence or condoms)

11. 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:

1. Pregnant or lactating

2. Treatment with COVID-19 antiviral such as remdesivir or SARS-CoV-2 antibodies

3. Prior COVID-19 vaccination or prior recovery from documented COVID-19 infection

4. 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

5. Positive HIV or positive Hepatitis Panel

6. Treatment with any medications known to be strongly metabolized by CYP3A4 or CYP2D6