Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (313 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-08-28, after 2021-08-11 start.
Reason given by the sponsor: “other”
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 2023-08-28. 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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Sponsor's past termination rate: 2.6% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: pulmonaryobstructivechronicfailureonset
Phrases that lowered it: the efficacyasthmarespiratoryclinicalmontelukast -
Phase: 3 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 64.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 4.3% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 115410 (lowers risk) · Drug's FDA history
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Disease area, neurology: 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 39 (typical: 32)
- Sponsor's past termination rate
- 2.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 115410 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14055 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- montelukast
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
- Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19 NCT05783206 · started 2022 · scored riskier than 15% of active trials completed
- LYT-100 in Post-acute COVID-19 Respiratory Disease NCT04652518 · started 2020 · scored riskier than 38% of active trials terminated
- Anakinra for COVID-19 Respiratory Symptoms NCT04364009 · started 2020 · scored riskier than 25% of active trials terminated
- NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) NCT04442230 · started 2020 · scored riskier than 65% of active trials terminated
- Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19 NCT04889040 · started 2021 · scored riskier than 29% 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.