Evidence map›Paper›PMID 33279656›Full record

SynthesisContemporary clinical trials2021

Reporting and design of randomized controlled trials for COVID-19: A systematic review.

Alison Dillman, Jay J H Park, Michael J Zoratti, Noor-E Zannat, Zelyn Lee, Louis Dron, Grace Hsu, Gerald Smith, Sahand Khakabimamaghani, Ofir Harari and 2 more

Registry-linked trialAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04727424 (A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04727424 phase3unknown statusnot on this map

A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19

TypeinterventionalSponsorCardresearchRan2021 to 2024Enrolled7,819ConditionsCovid19, SARS-Associated CoronavirusArmsSpirulin Platensis, Budesonide Powder, Fluoxetine 20 MG, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. 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

12 authors.

Alison DillmanSchool of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
Jay J H ParkDepartment of Experimental Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: jayhpark1@alumni.ubc.ca.
Michael J ZorattiDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Noor-E ZannatDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Zelyn LeeDepartment of Physiology & Department of Neuroscience, University of Toronto, Toronto, Canada.
Louis DronDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Grace HsuDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Gerald SmithDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Sahand KhakabimamaghaniSchool of Computing Science, Simon Fraser University, Burnaby, British Columbia, Canada.
Ofir HarariDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Kristian ThorlundDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Edward J MillsDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe novel coronavirus 2019 (COVID-19) pandemic has mobilized global research at an unprecedented scale. While challenges associated with the COVID-19 trial landscape have been discussed previously, no comprehensive reviews have been conducted to assess the reporting, design, and data sharing practices of randomized controlled trials (RCTs). PURPOSE: The purpose of this review was to gain insight into the current landscape of reporting, methodological design, and data sharing practices for COVID-19 RCTs. DATA SOURCES: We conducted three searches to identify registered clinical trials, peer-reviewed publications, and pre-print publications. STUDY SELECTION: After screening eight major trial registries and 7844 records, we identified 178 registered trials and 38 publications describing 35 trials, including 25 peer-reviewed publications and 13 pre-prints. DATA EXTRACTION: Trial ID, registry, location, population, intervention, control, study design, recruitment target, actual recruitment, outcomes, data sharing statement, and time of data sharing were extracted. DATA SYNTHESIS: Of 178 registered trials, 112 (62.92%) were in hospital settings, median planned recruitment was 100 participants (IQR: 60, 168), and the majority (n = 166, 93.26%) did not report results in their respective registries. Of 35 published trials, 31 (88.57%) were in hospital settings, median actual recruitment was 86 participants (IQR: 55.5, 218), 10 (28.57%) did not reach recruitment targets, and 27 trials (77.14%) reported plans to share data.

conclusionsThe findings of our study highlight limitations in the design and reporting practices of COVID-19 RCTs and provide guidance towards more efficient reporting of trial results, greater diversity in patient settings, and more robust data sharing.

Indexed as

COVID-19Randomized Controlled Trials as TopicData ManagementHumansQuality ImprovementResearch DesignSARS-CoV-2CoronavirusNovel coronavirus 2019Randomized controlled trialsSystematic literature review

Identifiers

PMID33279656
PMCPMC7834682

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.