Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat
Model scores of the 29,894 trials active now.
Model score 2% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-05-03, after 2020-11-02 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-05-03. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: treatmentcombinationchronicstudy ispatients
Phrases that lowered it: healthypharmacokineticsvolunteersto investigatesafety -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: factorial (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Number of arms: 6 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Maximum age: 45 (lowers risk) · Who can join
-
Blinding: double (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 80% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Disease area, psychiatry: No (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 5 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- niclosamide
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat NCT04750759 · started 2021 · scored riskier than 36% of active trials terminated
- Niclosamide for Mild to Moderate COVID-19 NCT04399356 · started 2020 · scored riskier than 36% of active trials completed
- The Nitazoxanide Plus Atazanavir for COVID-19 Study NCT04459286 · started 2020 · scored riskier than 33% of active trials terminated
- Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection NCT04858425 · started 2021 · scored riskier than 24% of active trials terminated
- A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19 NCT04605588 · started 2020 · scored riskier than 46% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.