Evidence map›Paper›PMID 33865476›Full record

ReviewThe Lancet. Global health2021

How COVID-19 has fundamentally changed clinical research in global health.

Jay J H Park, Robin Mogg, Gerald E Smith, Etheldreda Nakimuli-Mpungu, Fyezah Jehan, Craig R Rayner, Jeanine Condo, Eric H Decloedt, Jean B Nachega, Gilmar Reis and 1 more

Registry-linked trialOpen access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Global health, 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 120 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 8 pooled it
15.9field-weighted citation impact, top 1% 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.

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

120 citing papers in PubMed, 8 syntheses or guidelines pooled it, 220 citations in OpenAlex.

  1. Pooled it
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  9. Burden and care time for dementia caregivers in the LIVE@Home.Path trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Trial
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  19. Investigating Longitudinal Trajectories of COVID-19 Disruption: Methodological Challenges and Recommendations.Prevention science : the official journal of the Society for Prevention Research · 2026
    Article
  20. Article

60 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 11 institutions in 8 countries.

Jay J H ParkDepartment of Experimental Medicine, University of British Columbia, Vancouver, BC, Canada.
Robin MoggBill & Melinda Gates Medical Research Institute, Boston, MA, USA.
Gerald E SmithDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Etheldreda Nakimuli-MpunguDepartment of Psychiatry, Makerere University, Kampala, Uganda.
Fyezah JehanDepartment of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.
Craig R RaynerMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia; Certara, Princeton, NJ, USA.
Jeanine CondoSchool of Public Health, University of Rwanda, Kigali, Rwanda.
Eric H DecloedtDepartment of Medicine, Division of Clinical Pharmacology, Stellenbosch University, Cape Town, South Africa.
Jean B NachegaDepartment of Medicine and Center for Infectious Diseases, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; Department of Epidemiology and Department of Infectious Diseases and Microbiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA; Department of Epidemiology and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Gilmar ReisDepartamento de Medicina, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil.
Edward J MillsDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Cytel, Vancouver, BC, Canada; School of Public Health, University of Rwanda, Kigali, Rwanda. Electronic address: millsej@mcmaster.ca.
Aga Khan University · PKCertara (United States) · USGates Foundation · USImpact · CAMakerere University · UGMcMaster University · CAPontifícia Universidade Católica de Minas Gerais · BRStellenbosch University · ZAUniversity of British Columbia · CAUniversity of Kigali · RWUniversity of Pittsburgh · US

Funding

African Association for Health Professions Education and ResearchR25TW011217 · FIC · INFECTIOUS DISEASES INSTITUTE · PI ADEJUMO, PRISCA, NACHEGA, JEAN BISIMWA · 2018 to 2023
$3.9M
FIC NIH HHS R25 TW011217Medical Research Council MR/L004283/1
6 · The paper itself

Abstract

COVID-19 has had negative repercussions on the entire global population. Despite there being a common goal that should have unified resources and efforts, there have been an overwhelmingly large number of clinical trials that have been registered that are of questionable methodological quality. As the final paper of this Series, we discuss how the medical research community has responded to COVID-19. We recognise the incredible pressure that this pandemic has put on researchers, regulators, and policy makers, all of whom were doing their best to move quickly but safely in a time of tremendous uncertainty. However, the research community's response to the COVID-19 pandemic has prominently highlighted many fundamental issues that exist in clinical trial research under the current system and its incentive structures. The COVID-19 pandemic has not only re-emphasised the importance of well designed randomised clinical trials but also highlighted the need for large-scale clinical trials structured according to a master protocol in a coordinated and collaborative manner. There is also a need for structures and incentives to enable faster data sharing of anonymised datasets, and a need to provide similar opportunities to those in high-income countries for clinical trial research in low-resource regions where clinical trial research receives considerably less research funding.

Indexed as

Global HealthBiomedical ResearchCOVID-19HumansRandomized Controlled Trials as Topic

Identifiers

PMID33865476
PMCPMC8049590
OpenAlexW3156399049

What Socratic 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 Socratic graph.