Evidence map›Paper›PMID 33942351›Full record

ArticleRisk analysis : an official publication of the Society for Risk Analysis2021

Exploring Risks of Human Challenge Trials For COVID-19.

David Manheim, Witold Wiȩcek, Virginia Schmit, Josh Morrison, 1Day Sooner Research Team

Open access · hybridAbstract read
In one paragraph

Article in Risk analysis : an official publication of the Society for Risk Analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. The Case for Human Challenge Trials in COVID-19.Journal of bioethical inquiry · 2024
    Article
  6. A template for the authoring of statistical analysis plans.Contemporary clinical trials communications · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. A new day for human challenge trials?Trends in molecular medicine · 2022
    Article
  12. Testing fractional doses of COVID-19 vaccines.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  13. Article
  14. Global Systemic Risk and Resilience for Novel Coronavirus and COVID-19.Risk analysis : an official publication of the Society for Risk Analysis · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 3 countries.

David Manheim1DaySooner, Wilmington, DE, USA.ORCID 0000-0001-8599-8380
Witold Wiȩcek1DaySooner, Wilmington, DE, USA.ORCID 0000-0003-3016-1449
Virginia Schmit1DaySooner, Wilmington, DE, USA.ORCID 0000-0002-9894-0505
Josh Morrison1DaySooner, Wilmington, DE, USA.
1Day Sooner Research Team1DaySooner, Wilmington, DE, USA.
Wilmington University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Human challenge trials (HCTs) are a potential method to accelerate development of vaccines and therapeutics. However, HCTs for COVID-19 pose ethical and practical challenges, in part due to the unclear and developing risks. In this article , we introduce an interactive model for exploring some risks of a severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) dosing study, a prerequisite for any COVID-19 challenge trials. The risk estimates we use are based on a Bayesian evidence synthesis model which can incorporate new data on infection fatality risks (IFRs) to patients, and infer rates of hospitalization. The model estimates individual risk, which we then extrapolate to overall mortality and hospitalization risk in a dosing study. We provide a web tool to explore risk under different study designs. Based on the Bayesian model, IFR for someone between 20 and 30 years of age is 15.1 in 100,000, with a 95% uncertainty interval from 11.8 to 19.2, while risk of hospitalization is 130 per 100,000 (100-160). However, risk will be reduced in an HCT via screening for comorbidities, selecting lower-risk population, and providing treatment. Accounting for this with stronger assumptions, we project the fatality risk to be as low as 2.5 per 100,000 (1.6-3.9) and the hospitalization risk to be 22.0 per 100,000 (14.0-33.7). We therefore find a 50-person dosing trial has a 99.74% (99.8-99.9%) chance of no fatalities, and a 98.9% (98.3-99.3%) probability of no cases requiring hospitalization.

Indexed as

Risk AssessmentAntiviral AgentsBayes TheoremCOVID-19COVID-19 VaccinesEthics, ResearchHumansSARS-CoV-2Antiviral AgentsCOVID-19 VaccinesBayesian meta-analysisCOVID-19human challenge trialinformed consentinteractive modelsrisk communication

Identifiers

PMID33942351
PMCPMC8207107
OpenAlexW3157158131

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.