Status:
UNKNOWN
SLV213 Treatment in Ambulatory COVID-19 Patients
Lead Sponsor:
Kenneth Krantz, MD, PhD
Collaborating Sponsors:
FHI Clinical, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 asse...
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 assessme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04843787
Start Date
November 1 2023
End Date
July 1 2024
Last Update
April 12 2023
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