Trial reportThe Journal of infectious diseases2023
Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials.
Trial report in The Journal of infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04518410 (Adaptive Platform Treatment Trial for Outpatients With COVID-19), which is not on this map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Who cites it
7 citing papers in PubMed.
- Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial.The Journal of infectious diseases · 2024Trial
- Body Mass Index and Vaccine-induced Immune Responses in Children Living With HIV.The Pediatric infectious disease journal · 2026Article
- Response to Drs de Grooth and Parienti.The Journal of infectious diseases · 2024Article
- SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals: A Secondary Cross-Protocol Analysis of 4 Randomized Trials.JAMA network open · 2024Article
- Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19.The New England journal of medicine · 2024Article
- Safety, Efficacy, and Pharmacokinetics of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies BMS-986414 (C135-LS) and BMS-986413 (C144-LS) Administered Subcutaneously in Non-Hospitalized Persons with COVID-19 in a Phase 2 Trial.Pathogens & immunity · 2024Article
- The Wilcoxon-Mann-Whitney Estimand Versus Differences in Medians or Means.Pharmaceutical statisticsArticle
Corrections and comments
- Update of
Authors and funding
16 authors.
Funding
Abstract
Most clinical trials evaluating coronavirus disease 2019 (COVID-19) therapeutics include assessments of antiviral activity. In recently completed outpatient trials, changes in nasal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA levels from baseline were commonly assessed using analysis of covariance (ANCOVA) or mixed models for repeated measures (MMRM) with single imputation for results below assay lower limits of quantification (LLoQ). Analyzing changes in viral RNA levels with singly imputed values can lead to biased estimates of treatment effects. In this article, using an illustrative example from the ACTIV-2 trial, we highlight potential pitfalls of imputation when using ANCOVA or MMRM methods, and illustrate how these methods can be used when considering values <LLoQ as censored measurements. Best practices when analyzing quantitative viral RNA data should include details about the assay and its LLoQ, completeness summaries of viral RNA data, and outcomes among participants with baseline viral RNA ≥ LLoQ, as well as those with viral RNA < LLoQ. Clinical Trials Registration. NCT04518410.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.