Back to resultsSLV213 Treatment in Ambulatory COVID-19 Patients
Primary Purpose
Covid19
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SLV213
SLV213
SLV213
Placebo
Placebo
Placebo
Sponsored by
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
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
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
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
COVID-19 Symptom Improvements
Time from randomization to an improvement of two points (from the status at randomization) on the COVID19 symptom scale
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
Negative SARC-CoV-2 Testing
Time to two successive nasopharyngeal swabs negative for SARS-CoV-2 by PCR testing
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)
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
Oxygen Support
Number of days without oxygen by non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation
Hospitalization
Proportion of subjects requiring hospitalization
COVID-19 Related Death
Proportion of subjects dying of COVID-19 related causes
Full Information
NCT ID
NCT04843787
First Posted
April 9, 2021
Last Updated
April 10, 2023
Sponsor
Kenneth Krantz, MD, PhD
Collaborators
FHI Clinical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04843787
Brief Title
SLV213 Treatment in Ambulatory COVID-19 Patients
Official Title
A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Phase 2a Study of SLV213 in Ambulatory Individuals Positive for COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Krantz, MD, PhD
Collaborators
FHI Clinical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Multiple Ascending Dose (MAD)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Multiple Ascending Dose Cohort 1
Arm Type
Experimental
Arm Description
Intervention: SLV213, 8 subjects will receive 200mg oral doses twice a day for seven consecutive days.
Arm Title
Placebo Comparator: Multiple Ascending Dose Cohort 1
Arm Type
Placebo Comparator
Arm Description
Intervention: Placebo, 4 subjects will receive an equivalent number of oral doses twice a day for seven consecutive days.
Arm Title
Experimental: Multiple Ascending Dose Cohort 2
Arm Type
Experimental
Arm Description
Intervention: SLV213, 8 subjects will receive 400mg oral doses twice a day for seven consecutive days.
Arm Title
Placebo Comparator: Multiple Ascending Dose Cohort 2
Arm Type
Placebo Comparator
Arm Description
Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses twice a day for seven consecutive days.
Arm Title
Experimental: Multiple Ascending Dose Cohort 3
Arm Type
Experimental
Arm Description
Intervention: SLV213, 8 subjects will receive 800mg oral doses once a day for seven consecutive days.
Arm Title
Placebo Comparator: Multiple Ascending Dose Cohort 3
Arm Type
Placebo Comparator
Arm Description
Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses once a day for seven consecutive days.
Arm Title
Experimental: Multiple Ascending Dose Cohort 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator: Multiple Ascending Dose Cohort 4
Arm Type
Placebo Comparator
Arm Description
Intervention: Placebo, 15 subjects will receive the equivalent number of oral doses once a day or twice a day for seven consecutive days.
Intervention Type
Drug
Intervention Name(s)
SLV213
Intervention Description
SLV213 oral capsule (200mg) BID
Intervention Type
Drug
Intervention Name(s)
SLV213
Intervention Description
SLV213 oral capsule (400mg) BID
Intervention Type
Drug
Intervention Name(s)
SLV213
Intervention Description
SLV213 oral capsule (800mg) QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule (200mg) BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule (400mg) BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule (800mg) QD
Primary Outcome Measure Information:
Title
Treatment-Emergent Adverse Events
Description
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).
Time Frame
21 days following treatment end
Secondary Outcome Measure Information:
Title
COVID-19 Symptom Improvements
Description
Time from randomization to an improvement of two points (from the status at randomization) on the COVID19 symptom scale
Time Frame
21 days following treatment end
Title
COVID-19 Symptom Resolution
Description
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
Time Frame
21 days following treatment end
Title
Negative SARC-CoV-2 Testing
Description
Time to two successive nasopharyngeal swabs negative for SARS-CoV-2 by PCR testing
Time Frame
Through Day 8
Title
SARS-CoV-2 Viral Load Change
Description
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)
Time Frame
Baseline and Day 8
Title
SpO2/FiO2 Ratio Change
Description
Change in SpO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) assessed at baseline then day 7
Time Frame
Baseline and Day 7
Title
Oxygen Support
Description
Number of days without oxygen by non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation
Time Frame
21 days following treatment end
Title
Hospitalization
Description
Proportion of subjects requiring hospitalization
Time Frame
21 days following treatment end
Title
COVID-19 Related Death
Description
Proportion of subjects dying of COVID-19 related causes
Time Frame
21 days following treatment end
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Ortega
Phone
+1 (240) 498-0176
Email
jortega@selvarx.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SLV213 Treatment in Ambulatory COVID-19 Patients
We'll reach out to this number within 24 hrs