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Covid19Phase 2NCT04843787

SLV213 Treatment in Ambulatory COVID-19 Patients

A Phase 2 study testing SLV213 in people with Covid19, run by Kenneth Krantz, MD, PhD.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
SLV213
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
No sites listed yet
Study dates
1 Nov 2023to 1 Jul 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Julia Ortega contact

+1 (240) 498-0176

jortega@selvarx.com

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Phase 2a Study of SLV213 in Ambulatory Individuals Positive for COVID-19

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.

Read the 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.

Conditions
Covid19
Being tested
SLV213, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLV213Drug

    SLV213 oral capsule (200mg) BID

  • SLV213Drug

    SLV213 oral capsule (400mg) BID

  • SLV213Drug

    SLV213 oral capsule (800mg) QD

  • PlaceboDrug

    Placebo oral capsule (200mg) BID

  • PlaceboDrug

    Placebo oral capsule (400mg) BID

  • PlaceboDrug

    Placebo oral capsule (800mg) QD

Study groups in NCT04843787
Study groupRoleWhat they receive
Experimental: Multiple Ascending Dose Cohort 1ExperimentalIntervention: SLV213, 8 subjects will receive 200mg oral doses twice a day for seven consecutive days.
Receives: Drug: SLV213
Placebo Comparator: Multiple Ascending Dose Cohort 1Placebo comparatorIntervention: Placebo, 4 subjects will receive an equivalent number of oral doses twice a day for seven consecutive days.
Receives: Drug: Placebo
Experimental: Multiple Ascending Dose Cohort 2ExperimentalIntervention: SLV213, 8 subjects will receive 400mg oral doses twice a day for seven consecutive days.
Receives: Drug: SLV213
Placebo Comparator: Multiple Ascending Dose Cohort 2Placebo comparatorIntervention: Placebo, 4 subjects will receive the equivalent number of oral doses twice a day for seven consecutive days.
Receives: Drug: Placebo
Experimental: Multiple Ascending Dose Cohort 3ExperimentalIntervention: SLV213, 8 subjects will receive 800mg oral doses once a day for seven consecutive days.
Receives: Drug: SLV213
Placebo Comparator: Multiple Ascending Dose Cohort 3Placebo comparatorIntervention: Placebo, 4 subjects will receive the equivalent number of oral doses once a day for seven consecutive days.
Receives: Drug: Placebo
Experimental: Multiple Ascending Dose Cohort 4ExperimentalIntervention: 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.
Receives: Drug: SLV213
Placebo Comparator: Multiple Ascending Dose Cohort 4Placebo comparatorIntervention: Placebo, 15 subjects will receive the equivalent number of oral doses once a day or twice a day for seven consecutive days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 21 days following treatment end

Secondary outcomes (8)

  1. COVID-19 Symptom Improvements

    Time from randomization to an improvement of two points (from the status at randomization) on the COVID19 symptom scale

    Measured: 21 days following treatment end

  2. 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

    Measured: 21 days following treatment end

  3. Negative SARC-CoV-2 Testing

    Time to two successive nasopharyngeal swabs negative for SARS-CoV-2 by PCR testing

    Measured: Through Day 8

  4. 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)

    Measured: Baseline and Day 8

  5. 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

    Measured: Baseline and Day 7

  6. Oxygen Support

    Number of days without oxygen by non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation

    Measured: 21 days following treatment end

  7. Hospitalization

    Proportion of subjects requiring hospitalization

    Measured: 21 days following treatment end

  8. COVID-19 Related Death

    Proportion of subjects dying of COVID-19 related causes

    Measured: 21 days following treatment end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start1 Nov 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Multiple Ascending Dose (MAD)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843787
Sponsor's protocol ID
SLV213-02
Status last verified
Apr 2023
First submitted
9 Apr 2021
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SLV213 in people with Covid19, run by Kenneth Krantz, MD, PhD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julia Ortega (+1 (240) 498-0176, jortega@selvarx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Emergent Adverse Events (time frame: 21 days following treatment end). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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