COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

NCT05181683 on ClinicalTrials.gov Phase 1 Regeneron Pharmaceuticals (industry) Started 2022-01-07 Completed

Riskier than 7% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (776 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2022-06-03, after 2022-01-07 start.

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 2022-06-03. 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: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 12.6% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 3.5% (lowers risk) · Drug's FDA history
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: canceracuterandomizationcoronarypulmonary
Phrases that lowered it: kghealthyvolunteersscreeningbmi
Trials the sponsor started in the prior 2 years: 48 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 71.5% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 151 (lowers risk) · Sponsor's track record
Disease area, respiratory: Yes (raises 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: 1 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 151 (typical: 32)
Sponsor's past termination rate: 12.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 48 (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: 4453 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4346 (typical: 412.5)
Drug's FAERS reports marked serious: 71.5% (typical: 85.6%)
Drug's FAERS reports with a death: 3.5% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: casirivimab, casirivimab imdevimab, imdevimab

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

COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 NCT05092581 · started 2021 · scored riskier than 22% of active trials terminated
COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age NCT04992273 · started 2021 · scored riskier than 13% of active trials terminated
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults NCT05074433 · started 2021 · scored riskier than 18% of active trials terminated
Study to Evaluate the Safety and Concentrations of Monoclonal Antibody Against Virus That Causes COVID-19 Disease. NCT04932850 · started 2021 · scored riskier than 2% of active trials completed
Non-inferiority Trial on Monoclonal Antibodies in COVID-19 NCT05205759 · started 2021 · scored riskier than 36% 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.