Studies
| Study First Submitted Date | 2021-04-09 |
| Study First Posted Date | 2021-04-14 |
| Last Update Posted Date | 2023-04-12 |
| Start Month Year | November 1, 2023 |
| Primary Completion Month Year | June 1, 2024 |
| Verification Month Year | April 2023 |
| Verification Date | 2023-04-30 |
| Last Update Posted Date | 2023-04-12 |
Detailed Descriptions
| Sequence: | 20688504 |
| 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. |
Conditions
| Sequence: | 52082752 |
| Name | Covid19 |
| Downcase Name | covid19 |
Id Information
| Sequence: | 40088177 |
| Id Source | org_study_id |
| Id Value | SLV213-02 |
Design Groups
| Sequence: | 55496687 | Sequence: | 55496688 | Sequence: | 55496689 | Sequence: | 55496690 | Sequence: | 55496691 | Sequence: | 55496692 | Sequence: | 55496693 | Sequence: | 55496694 |
| Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator |
| Title | Experimental: Multiple Ascending Dose Cohort 1 | Title | Placebo Comparator: Multiple Ascending Dose Cohort 1 | Title | Experimental: Multiple Ascending Dose Cohort 2 | Title | Placebo Comparator: Multiple Ascending Dose Cohort 2 | Title | Experimental: Multiple Ascending Dose Cohort 3 | Title | Placebo Comparator: Multiple Ascending Dose Cohort 3 | Title | Experimental: Multiple Ascending Dose Cohort 4 | Title | Placebo Comparator: Multiple Ascending Dose Cohort 4 |
| Description | Intervention: SLV213, 8 subjects will receive 200mg oral doses twice a day for seven consecutive days. | Description | Intervention: Placebo, 4 subjects will receive an equivalent number of oral doses twice a day for seven consecutive days. | Description | Intervention: SLV213, 8 subjects will receive 400mg oral doses twice a day for seven consecutive days. | Description | Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses twice a day for seven consecutive days. | Description | Intervention: SLV213, 8 subjects will receive 800mg oral doses once a day for seven consecutive days. | Description | Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses once a day for seven consecutive days. | 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. | Description | Intervention: Placebo, 15 subjects will receive the equivalent number of oral doses once a day or twice a day for seven consecutive days. |
Interventions
| Sequence: | 52395907 | Sequence: | 52395908 | Sequence: | 52395909 | Sequence: | 52395910 | Sequence: | 52395911 | Sequence: | 52395912 |
| Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
| Name | SLV213 | Name | SLV213 | Name | SLV213 | Name | Placebo | Name | Placebo | Name | Placebo |
| Description | SLV213 oral capsule (200mg) BID | Description | SLV213 oral capsule (400mg) BID | Description | SLV213 oral capsule (800mg) QD | Description | Placebo oral capsule (200mg) BID | Description | Placebo oral capsule (400mg) BID | Description | Placebo oral capsule (800mg) QD |
Design Outcomes
| Sequence: | 177078009 | Sequence: | 177078010 | Sequence: | 177078011 | Sequence: | 177078012 | Sequence: | 177078013 | Sequence: | 177078014 | Sequence: | 177078015 | Sequence: | 177078016 | Sequence: | 177078017 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Treatment-Emergent Adverse Events | Measure | COVID-19 Symptom Improvements | Measure | COVID-19 Symptom Resolution | Measure | Negative SARC-CoV-2 Testing | Measure | SARS-CoV-2 Viral Load Change | Measure | SpO2/FiO2 Ratio Change | Measure | Oxygen Support | Measure | Hospitalization | Measure | COVID-19 Related Death |
| Time Frame | 21 days following treatment end | Time Frame | 21 days following treatment end | Time Frame | 21 days following treatment end | Time Frame | Through Day 8 | Time Frame | Baseline and Day 8 | Time Frame | Baseline and Day 7 | Time Frame | 21 days following treatment end | Time Frame | 21 days following treatment end | Time Frame | 21 days following treatment end |
| 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). | Description | Time from randomization to an improvement of two points (from the status at randomization) on the COVID19 symptom scale | 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 | Description | Time to two successive nasopharyngeal swabs negative for SARS-CoV-2 by PCR testing | 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) | 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 | Description | Number of days without oxygen by non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation | Description | Proportion of subjects requiring hospitalization | Description | Proportion of subjects dying of COVID-19 related causes |
Browse Conditions
| Sequence: | 193135208 | Sequence: | 193135209 | Sequence: | 193135210 | Sequence: | 193135211 | Sequence: | 193135212 | Sequence: | 193135213 | Sequence: | 193135214 | Sequence: | 193135215 | Sequence: | 193135216 | Sequence: | 193135217 | Sequence: | 193135218 | Sequence: | 193135219 |
| Mesh Term | COVID-19 | Mesh Term | Pneumonia, Viral | Mesh Term | Pneumonia | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Virus Diseases | Mesh Term | Coronavirus Infections | Mesh Term | Coronaviridae Infections | Mesh Term | Nidovirales Infections | Mesh Term | RNA Virus Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
| Downcase Mesh Term | covid-19 | Downcase Mesh Term | pneumonia, viral | Downcase Mesh Term | pneumonia | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | coronavirus infections | Downcase Mesh Term | coronaviridae infections | Downcase Mesh Term | nidovirales infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48237419 | Sequence: | 48237420 |
| Agency Class | INDUSTRY | Agency Class | UNKNOWN |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | Kenneth Krantz, MD, PhD | Name | FHI Clinical, Inc. |
Central Contacts
| Sequence: | 11990421 |
| Contact Type | primary |
| Name | Julia Ortega |
| Phone | +1 (240) 498-0176 |
| jortega@selvarx.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68031792 | Sequence: | 68031793 | Sequence: | 68031794 | Sequence: | 68031795 | Sequence: | 68031796 | Sequence: | 68031797 | Sequence: | 68031798 | Sequence: | 68031799 | Sequence: | 68031800 | Sequence: | 68031801 | Sequence: | 68031802 | Sequence: | 68031803 |
| Design Group Id | 55496687 | Design Group Id | 55496693 | Design Group Id | 55496689 | Design Group Id | 55496693 | Design Group Id | 55496691 | Design Group Id | 55496693 | Design Group Id | 55496688 | Design Group Id | 55496694 | Design Group Id | 55496690 | Design Group Id | 55496694 | Design Group Id | 55496692 | Design Group Id | 55496694 |
| Intervention Id | 52395907 | Intervention Id | 52395907 | Intervention Id | 52395908 | Intervention Id | 52395908 | Intervention Id | 52395909 | Intervention Id | 52395909 | Intervention Id | 52395910 | Intervention Id | 52395910 | Intervention Id | 52395911 | Intervention Id | 52395911 | Intervention Id | 52395912 | Intervention Id | 52395912 |
Eligibilities
| Sequence: | 30714059 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253945753 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 8 |
Designs
| Sequence: | 30460628 |
| Allocation | Randomized |
| Intervention Model | Sequential Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Quadruple |
| Masking Description | Double-Blind |
| Intervention Model Description | Multiple Ascending Dose (MAD) |
| Subject Masked | True |
| Caregiver Masked | True |
| Investigator Masked | True |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28827088 |
| Responsible Party Type | Sponsor-Investigator |
| Name | Kenneth Krantz, MD, PhD |
| Title | Chief Medical Officer |
| Affiliation | Selva Therapeutics, Inc. |