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Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV)

2020· preprint· en· W3092950706 on OpenAlexfundno aff
William HK Schilling, James J. Callery, Walter Taylor, Mavuto Mukaka, Maneerat Ekkapongpisit, James A Watson, Arjun Chandna, Salwaluk Panapipat, Jaruwan Tubprasert, Prayoon Yuentrakul, Naomi Waithira, T Cope, Mehul Dhorda, Cintia Cruz, Lorenz von Seidlein, Joanne Milton, Martin Llewelyn, Amanda Adler, Kesinee Chotivanich, Phaik Yeong Cheah, Elizabeth A. Ashley, Mayfong Mayxay, Arjen M. Dondorp, Weerapong Phumratanaprapin, Nicholas Day, Nicholas J. White

Bibliographic record

VenueWellcome Open Research · 2020
Typepreprint
Languageen
FieldMedicine
TopicCOVID-19 Clinical Research Studies
Canadian institutionsnot available
FundersMastercard FoundationWellcome TrustBill and Melinda Gates Foundation
KeywordsHydroxychloroquineChloroquineMedicinePlaceboAdverse effectPandemicRandomized controlled trialClinical trialIntensive care medicineInternal medicineCoronavirus disease 2019 (COVID-19)DiseaseImmunologyMalariaAlternative medicineInfectious disease (medical specialty)Pathology

Abstract

fetched live from OpenAlex

<ns3:p>There is no proven preventative therapy or vaccine against COVID-19. Theinfection has spread rapidly and there has already been a substantial adverse impact on the global economy. Healthcare workers have been affected disproportionately in the continuing pandemic. Significant infection rates in this critical group have resulted in a breakdown of health services in some countries. Chloroquine, and the closely related hydroxychloroquine, are safe and well tolerated medications which can be given for years without adverse effects. Chloroquine and hydroxychloroquine have significant antiviral activity against SARS-CoV-2, and despite the lack of benefit of hydroxychloroquine treatment in patients hospitalised with severe COVID-19, these drugs could still work in prevention. The emerging infection paradigm of an early viral peak, and late inflammation where there is benefit from corticosteroids. If these direct actiing antivirals are to work, they have the best chance given either early in infection and before infection occurs. We describe the study protocol for a multi-centre, multi-country randomised, double blind, placebo controlled trial to answer the question- can chloroquine/ hydroxychloroquine prevent COVID-19. 40,000 participants working in healthcare facilities or involved in the management of COVID-19 will be randomised 1:1 to receive chloroquine/ hydroxychloroquine or matched placebo as daily prophylaxis for three months. The primary objective is the prevention of symptomatic, virological or serologically proven coronavirus disease (COVID-19). The study could detect a 23% reduction from an incidence of 3% in the placebo group for either drug with 80% power. Secondary objectives are to determine if chloroquine/hydroxychloroquine prophylaxis attenuates severity, prevents asymptomaticCOVID-19 and symptomatic acute respiratory infections of another aetiology (non-SARS-CoV-2).</ns3:p>

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.044
metaresearch head score (Gemma)0.181
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow), Open science, Research integrity
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.411
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0440.181
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0040.001
Bibliometrics0.0010.002
Science and technology studies0.0010.001
Scholarly communication0.0000.000
Open science0.0050.009
Research integrity0.0000.005
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.467
GPT teacher head0.605
Teacher spread0.137 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; both teacher heads agree on what is shown here.

Study designRandomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations9
Published2020
Admission routes1
Has abstractyes

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