SLV213 Treatment in Ambulatory COVID-19 Patients

NCT04843787 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SLV213-02
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• COVID-19 Symptom Improvements

  21 days following treatment end

• COVID-19 Symptom Resolution

  21 days following treatment end

• Negative SARC-CoV-2 Testing

  Through Day 8

• SARS-CoV-2 Viral Load Change

  Baseline and Day 8

• SpO2/FiO2 Ratio Change

  Baseline and Day 7

Study Arms (8)

Experimental: Multiple Ascending Dose Cohort 1

EXPERIMENTAL

Intervention: SLV213, 8 subjects will receive 200mg oral doses twice a day for seven consecutive days.

Drug: SLV213

Placebo Comparator: Multiple Ascending Dose Cohort 1

PLACEBO COMPARATOR

Intervention: Placebo, 4 subjects will receive an equivalent number of oral doses twice a day for seven consecutive days.

Drug: Placebo

Experimental: Multiple Ascending Dose Cohort 2

EXPERIMENTAL

Intervention: SLV213, 8 subjects will receive 400mg oral doses twice a day for seven consecutive days.

Drug: SLV213

Placebo Comparator: Multiple Ascending Dose Cohort 2

PLACEBO COMPARATOR

Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses twice a day for seven consecutive days.

Drug: Placebo

Experimental: Multiple Ascending Dose Cohort 3

EXPERIMENTAL

Intervention: SLV213, 8 subjects will receive 800mg oral doses once a day for seven consecutive days.

Drug: SLV213

Placebo Comparator: Multiple Ascending Dose Cohort 3

PLACEBO COMPARATOR

Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses once a day for seven consecutive days.

Drug: Placebo

Experimental: Multiple Ascending Dose Cohort 4

EXPERIMENTAL

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.

Drug: SLV213

Placebo Comparator: Multiple Ascending Dose Cohort 4

PLACEBO COMPARATOR

Intervention: Placebo, 15 subjects will receive the equivalent number of oral doses once a day or twice a day for seven consecutive days.

Drug: Placebo

Interventions

SLV213 DRUG

SLV213 oral capsule (200mg) BID

Experimental: Multiple Ascending Dose Cohort 1; Experimental: Multiple Ascending Dose Cohort 4

Placebo DRUG

Placebo oral capsule (200mg) BID

Placebo Comparator: Multiple Ascending Dose Cohort 1; Placebo Comparator: Multiple Ascending Dose Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Pregnant or lactating
• Treatment with COVID-19 antiviral such as remdesivir or SARS-CoV-2 antibodies
• 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
• 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

Sponsors & Collaborators

• Kenneth Krantz, MD, PhD: lead
• FHI Clinical, Inc.: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

N-pip-phenylalanine-homophenylalanine-vinyl sulfone phenyl

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Julia Ortega

CONTACT

+1 (240) 498-0176; jortega@selvarx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: Multiple Ascending Dose (MAD)

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 14, 2021
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share