Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

NCT04516811 on ClinicalTrials.gov Phase 3 South African National Blood Service (academic or other) Started 2020-09-21 Terminated

Riskier than 21% of active trials

Model scores of the 29,894 trials active now.

Model score 11% 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 2022-07-31, after 2020-09-21 start.

Reason given by the sponsor: “efficacy”

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 2022-07-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: trialadmissionplasma inhoursparticipation in
Phrases that lowered it: moderatepulmonarypatients whosevereclinical
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 40% (raises risk) · Drug's FDA history
Blinding: triple (raises 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
Sponsor type: academic or other (raises risk) · Sponsor's track record
Responsible party: principal investigator (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Number of arms: 2 (raises risk) · Design
Drug's FAERS reports before start: 5 (lowers risk) · Drug's FDA history
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
Collaborators: 0 (raises risk) · Design
Disease area, neurology: No (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: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (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: 5 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 40% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: covid19 convalescent plasma

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

Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia NCT04345289 · started 2020 · scored riskier than 48% of active trials terminated
A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19 NCT04433910 · started 2020 · scored riskier than 23% of active trials completed
Plasma Therapy of COVID-19 in Severely Ill Patients NCT04359810 · started 2020 · scored riskier than 57% of active trials completed
Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection NCT04375098 · started 2020 · scored riskier than 39% of active trials completed
Treatment of Patients With COVID-19 With Convalescent Plasma NCT04415086 · started 2020 · scored riskier than 12% 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.