SLV213 Treatment in Ambulatory COVID-19 Patients

Covid19 Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Phase 2a Study of SLV213 in Ambulatory Individuals Positive for COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04843787
• Other study ID #: SLV213-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2023
• Source: Selva Therapeutics, Inc.
• Contact: Julia Ortega
• Phone: +1 (240) 498-0176
• Email: jortega[@]selvarx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This double blind, placebo-controlled study will be conducted in two parts. Part A will determine the maximum tolerated dose (MTD) that will be used in Part B to confirm tolerance and provide assessment of the effect of SLV213 on clinical symptoms of COVID-19. Part A will consist of three sequential cohorts of 12 subjects receiving treatment administered orally either twice a day or once a day for seven consecutive days. Subjects in each cohort will be randomized to one of two treatment arms, SLV213 (8 subjects) or placebo (4 subjects). After each cohort, a Selva Safety Review Committee (SRC) will evaluate the safety of the regimen before proceeding to dose the next cohort. If a cohort is deemed to have reached an intolerable dose level, the dose prior to that level will be the MTD. PK blood samples will be collected throughout the study. In Part B of the study 45 subjects will be dosed at the MTD (30 SLV213 and 15 Placebo) to confirm tolerance, and to provide assessment of the effect of SLV213 on clinical symptoms of COVID-19. PK blood samples will be collected throughout the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

9. 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 ß-subunit of HCG

Exclusion Criteria:

1. Pregnant or lactating

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

3. 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

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• SLV213
SLV213 oral capsule (200mg) BID
• SLV213
SLV213 oral capsule (400mg) BID
• SLV213
SLV213 oral capsule (800mg) QD
• Placebo
Placebo oral capsule (200mg) BID
• Placebo
Placebo oral capsule (400mg) BID
• Placebo
Placebo oral capsule (800mg) QD

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emergent Adverse Events	Proportion of participants experiencing any treatment-emergent adverse events judged possibly or probably related to study drug vs. placebo (drug-related adverse events as determined by abnormal clinical laboratory tests, vitals signs, blood pressure monitoring and collection (systolic, diastolic, pulse pressure, heart rate and mean arterial pressure), physical exam and ECG parameters).	21 days following treatment end
Secondary	COVID-19 Symptom Improvements	Time from randomization to an improvement of two points (from the status at randomization) on the COVID19 symptom scale	21 days following treatment end
Secondary	COVID-19 Symptom Resolution	Time from randomization to resolution of COVID-19 clinical symptoms (e.g. fever, cough, shortness of breath, etc. as described below). Resolution defined as the start of the first 24-hour period when all symptoms are rated as mild or absent and have remained this way for 24 hours	21 days following treatment end
Secondary	Negative SARC-CoV-2 Testing	Time to two successive nasopharyngeal swabs negative for SARS-CoV-2 by PCR testing	Through Day 8
Secondary	SARS-CoV-2 Viral Load Change	Change in SARS-CoV-2 viral load measured in plasma samples (e.g., change in the slope of the SARS-CoV-2 log viral load assessed at baseline and Day 8)	Baseline and Day 8
Secondary	SpO2/FiO2 Ratio Change	Change in SpO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) assessed at baseline then day 7	Baseline and Day 7
Secondary	Oxygen Support	Number of days without oxygen by non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation	21 days following treatment end
Secondary	Hospitalization	Proportion of subjects requiring hospitalization	21 days following treatment end
Secondary	COVID-19 Related Death	Proportion of subjects dying of COVID-19 related causes	21 days following treatment end