Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-08-28, after 2020-03-24 start.
Reason given by the sponsor: “safety”
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 2020-08-28. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: stagepatientpatientschronic kidneybreast
Phrases that lowered it: participantsopen labelkgrespiratorysafety of -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 13.9% (raises risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 5.7% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 124938 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 70.2% (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 115 (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 115 (typical: 32)
- Sponsor's past termination rate
- 13.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 24 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 124938 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 23782 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- azithromycin, hydroxychloroquine
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
- Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 NCT04358068 · started 2020 · scored riskier than 65% of active trials terminated
- Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease NCT04358081 · started 2020 · scored riskier than 79% of active trials completed
- Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection NCT04341727 · started 2020 · scored riskier than 76% of active trials terminated
- Treating COVID-19 With Hydroxychloroquine (TEACH) NCT04369742 · started 2020 · scored riskier than 82% of active trials terminated
- A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers NCT04461353 · started 2020 · scored riskier than 4% of active trials completed
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.