Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS
Model scores of the 29,894 trials active now.
Model score 24% 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 (47 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-03-26, after 2020-07-23 start.
Reason given by the sponsor: “business”
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 2024-03-26. 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: lunggradeimagingtherapybone
Phrases that lowered it: subjectsdiseasesand safetysafety ofefficacy and -
Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Phase: 2/3 (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 50% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- none matched
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
- Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness NCT05298813 · started 2021 · scored riskier than 15% of active trials completed
- A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19 NCT04733833 · started 2021 · scored riskier than 56% of active trials completed
- Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease NCT04376684 · started 2020 · scored riskier than 82% of active trials completed
- Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness NCT05303376 · started 2022 · scored riskier than 60% of active trials completed
- Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia NCT04333420 · started 2020 · scored riskier than 61% 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.