A Phase 2 interventional study of SLV213 and SLV213 in Covid19, sponsored by Kenneth Krantz, MD, PhD. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Kenneth Krantz, MD, PhD · Phase 2, Interventional, and Treatment
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.
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.
7,776 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 81 is below the median of 100 across 4,176 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Kenneth Krantz, MD, PhD as lead sponsor.
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Women of child-bearing potential must meet all the following criteria:
Exclusion Criteria:
At increased risk of developing more severe COVID-19 disease (at least one of the following):
Intervention: SLV213, 8 subjects will receive 200mg oral doses twice a day for seven consecutive days.
Drug: SLV213
Intervention: Placebo, 4 subjects will receive an equivalent number of oral doses twice a day for seven consecutive days.
Drug: Placebo
Intervention: SLV213, 8 subjects will receive 400mg oral doses twice a day for seven consecutive days.
Drug: SLV213
Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses twice a day for seven consecutive days.
Drug: Placebo
Intervention: SLV213, 8 subjects will receive 800mg oral doses once a day for seven consecutive days.
Drug: SLV213
Intervention: Placebo, 4 subjects will receive the equivalent number of oral doses once a day for seven consecutive days.
Drug: Placebo
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
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
SLV213 oral capsule (200mg) BID
SLV213 oral capsule (400mg) BID
SLV213 oral capsule (800mg) QD
Placebo oral capsule (200mg) BID
Placebo oral capsule (400mg) BID
Placebo oral capsule (800mg) QD
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).
Time frame: 21 days following treatment end
COVID-19 Symptom Improvements
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
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
Time frame: 21 days following treatment end
Negative SARC-CoV-2 Testing
Time to two successive nasopharyngeal swabs negative for SARS-CoV-2 by PCR testing
Time frame: Through Day 8
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)
Time frame: 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
Time frame: Baseline and Day 7
Oxygen Support
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
Hospitalization
Proportion of subjects requiring hospitalization
Time frame: 21 days following treatment end
COVID-19 Related Death
Proportion of subjects dying of COVID-19 related causes
Time frame: 21 days following treatment end
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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