Does Hydroxychloroquine Before & During Patient Exposure Protect Healthcare Workers From Coronavirus?
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 8% 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
Terminated on 2021-03-31, after 2020-04-30 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 2021-03-31. 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: enrollmentcarehoursbreastemergency department
Phrases that lowered it: participantshealthto evaluateand safetysafety of -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Primary purpose: prevention (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Responsible party: sponsor investigator (raises risk) · Design
-
Drug's FAERS reports with a death: 4.0% (lowers risk) · Drug's FDA history
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 70.0% (lowers risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 75258 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14758 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- 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
- Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine NCT04334148 · started 2020 · scored riskier than 36% of active trials completed
- Pre-exposure Prophylaxis for SARS-Coronavirus-2 NCT04328467 · started 2020 · scored riskier than 42% of active trials completed
- Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP) NCT04328961 · started 2020 · scored riskier than 7% of active trials completed
- Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers NCT04333225 · started 2020 · scored riskier than 20% of active trials completed
- Will Hydroxychloroquine Impede or Prevent COVID-19 NCT04341441 · started 2020 · scored riskier than 10% 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.