Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (1,012 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-12-31, after 2021-02-15 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 2021-12-31. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientcancerfailurechemotherapycare
Phrases that lowered it: 19respiratorymmhgpressuredisorder -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 20% (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 50% (raises risk) · Drug's FDA history
-
Blinding: quadruple (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: 85 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Phase: 2/3 (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Drug's FAERS reports before start: 2 (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
- 2/3 (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
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 5 (typical: 32)
- Sponsor's past termination rate
- 20% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 2 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 50% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- aviptadil
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
- Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure NCT04311697 · started 2020 · scored riskier than 75% of active trials completed
- Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection NCT04344288 · started 2020 · scored riskier than 47% of active trials terminated
- Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS NCT04536350 · started 2021 · scored riskier than 66% of active trials terminated
- Study of Varespladib in Patients Hospitalized With Severe COVID-19 NCT04969991 · started 2021 · scored riskier than 35% of active trials terminated
- Treat COVID-19 Patients With Regadenoson NCT04606069 · started 2021 · scored riskier than 69% 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.