Non-inferiority Trial on Treatments in Early COVID-19
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 10% of the time (313 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-29, after 2022-03-07 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 2023-10-29. 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: painsubject30onsetrandomization
Phrases that lowered it: participantsprogressionmonoclonalbreastefficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 13.3% (raises risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 9.9% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 2 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Drugs with FDA adverse-event history: 6 (lowers risk) · Drug's FDA history
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Minimum age: 50 (lowers risk) · Who can join
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports marked serious: 87.8% (raises risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 4463 (raises risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 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
- 15 (typical: 32)
- Sponsor's past termination rate
- 13.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 6 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 39534 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4463 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- cilgavimab, nirmatrelvir, nirmatrelvir ritonavir, ritonavir, sotrovimab, tixagevimab
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
- Non-inferiority Trial on Monoclonal Antibodies in COVID-19 NCT05205759 · started 2021 · scored riskier than 36% of active trials terminated
- Adaptive COVID-19 Treatment Trial 2 (ACTT-2) NCT04401579 · started 2020 · scored riskier than 62% of active trials completed
- A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19 NCT05506176 · started 2022 · scored riskier than 46% of active trials completed
- A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 NCT05305547 · started 2022 · scored riskier than 50% of active trials completed
- COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease NCT05081388 · started 2021 · scored riskier than 60% 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.