Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 10% 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
Completed on 2022-01-18, after 2020-06-01 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 2022-01-18. 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: placeboadministrationdrinksrandomizationhepatitis
Phrases that lowered it: patients whoqtaminotransferasepainupper -
Sponsor's past termination rate: 14.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 87 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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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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Drug's FAERS reports with a death: 10.7% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 91.2% (raises risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Sponsor's past trials: 177 (lowers risk) · Sponsor's track record
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Design: sequential (lowers risk) · Design
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Number of arms: 2 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports before start: 47580 (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 3 (lowers 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 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
- 177 (typical: 32)
- Sponsor's past termination rate
- 14.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 87 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 47580 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3864 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- lopinavir, lopinavir ritonavir, ritonavir
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
- Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients NCT04718480 · started 2020 · scored riskier than 17% of active trials completed
- A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID. NCT05668091 · started 2023 · scored riskier than 73% of active trials completed
- COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19) NCT04510194 · started 2021 · scored riskier than 28% of active trials completed
- Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection NCT04784559 · started 2021 · scored riskier than 77% of active trials terminated
- Treatment for COVID-19 in High-Risk Adult Outpatients NCT04354428 · started 2020 · scored riskier than 43% 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.