Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial

NCT04339816 on ClinicalTrials.gov Phase 3 Frantisek Duska, MD, PhD (academic or other) Started 2020-05-13 Terminated

Riskier than 24% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 7% 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 2020-11-04, after 2020-05-13 start.

Reason given by the sponsor: “other”

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 2020-11-04. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Collaborators: 7 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placeboadmissionlong qtrandomizationfree
Phrases that lowered it: participantsbloodpatients1419
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Responsible party: sponsor investigator (raises risk) · Design
Drug's FAERS reports with a death: 5.8% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Blinding: triple (raises risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Number of arms: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 70.9% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 130643 (lowers risk) · Drug's FDA history
Sponsor's past trials: 0 (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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor investigator (typical: sponsor)
Collaborators: 7 (typical: 0)
Keywords listed: 5 (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: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 130643 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 24919 (typical: 412.5)
Drug's FAERS reports marked serious: 70.9% (typical: 85.6%)
Drug's FAERS reports with a death: 5.8% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: aqua, azithromycin, 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

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease NCT04344444 · started 2020 · scored riskier than 63% of active trials terminated
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 NCT04581915 · started 2020 · scored riskier than 47% of active trials terminated
COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19 NCT04328012 · started 2020 · scored riskier than 83% of active trials terminated
Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease NCT04358081 · started 2020 · scored riskier than 79% of active trials completed
Multi-site Adaptive Trials for COVID-19 NCT04370262 · started 2020 · scored riskier than 95% 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.