Evidence map›Paper›PMID 32673060›Full record

Trial reportAnnals of internal medicine2020

Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.

Caleb P Skipper, Katelyn A Pastick, Nicole W Engen, Ananta S Bangdiwala, Mahsa Abassi, Sarah M Lofgren, Darlisha A Williams, Elizabeth C Okafor, Matthew F Pullen, Melanie R Nicol and 14 more

Erratum issued 3 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of internal medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 301 papers, 36 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
301citing papers in PubMed, 36 pooled it
13.0field-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.

NCT04308668 phase3completednot on this map

Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

TypeinterventionalSponsorUniversity of MinnesotaRan2020 to 2020Enrolled1,312ConditionsCorona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection, CoronavirusArmsHydroxychloroquine, Placebo
NCT04421664 phase3terminatednot on this map

Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2020 to 2020Enrolled70ConditionsCorona Virus Infection, SARS-CoV Infection, CoronavirusArmsHydroxychloroquine, Placebo oral tablet
NCT04533347 phase2completednot on this mapstarted 2021, after this paper: background citation

A Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of Oral Tafenoquine Versus Placebo in Patients With Mild to Moderate COVID-19 Disease

TypeinterventionalSponsor60 Degrees Pharmaceuticals LLCRan2021 to 2022Enrolled86ConditionsCOVID 19 DiseaseArmsTafenoquine Oral Tablet, Placebo
3 · Its place in the literature

Who cites it

301 citing papers in PubMed, 36 syntheses or guidelines pooled it, 546 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Pooled it
  20. Pooled it

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 6 institutions in 2 countries.

Caleb P SkipperUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0002-0000-8876
Katelyn A PastickUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0002-1306-1713
Nicole W EngenUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0003-1118-4194
Ananta S BangdiwalaUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0003-0062-9434
Mahsa AbassiUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0001-9601-3006
Sarah M LofgrenUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0001-6717-2614
Darlisha A WilliamsUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
Elizabeth C OkaforUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0003-1495-4596
Matthew F PullenUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0002-4644-7487
Melanie R NicolUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0001-5513-5509
Alanna A NasceneUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0002-5622-5810
Kathy H HullsiekUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0002-2754-3473
Matthew P ChengResearch Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).ORCID 0000-0002-4867-2063
Darlette LukeM Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).
Sylvain A LotherUniversity of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).ORCID 0000-0003-1927-2682
Lauren J MacKenzieUniversity of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).ORCID 0000-0002-4794-9120
Glen DrobotUniversity of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).ORCID 0000-0002-0879-9668
Lauren E KellyGeorge & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).ORCID 0000-0001-7567-0816
Ilan S SchwartzUniversity of Alberta, Edmonton, Alberta, Canada (I.S.S.).ORCID 0000-0002-7522-0281
Ryan ZarychanskiUniversity of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).ORCID 0000-0001-9455-6138
Emily G McDonaldResearch Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).ORCID 0000-0003-0783-0624
Todd C LeeResearch Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).ORCID 0000-0002-2267-4239
Radha RajasinghamUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).ORCID 0000-0001-5531-0231
David R BoulwareUniversity of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
University of Minnesota · USUniversity of Manitoba · CAMcGill University Health Centre · CAFairview Health Services · USGeorge & Fay Yee Centre for Healthcare Innovation · CAUniversity of Alberta · CA

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR002494 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, WEISDORF, DANIEL J · 2018 to 2022
$34.9M
Infectious Disease Training in Clinical InvestigationT32AI055433 · NIAID · UNIVERSITY OF MINNESOTA TWIN CITIES · PI David R Boulware · 2003 to 2026
$6.1M
Operational Research for Cryptococcal Antigen Screening (ORCAS) of HIV PatientsU01AI125003 · NIAID · UNIVERSITY OF MINNESOTA · PI BOULWARE, DAVID R, MEYA, DAVID BISAGAYA · 2016 to 2020
$3.4M
Encochleated Oral Amphotericin for Cryptococcal Meningitis TrialR01NS110519 · NINDS · UNIVERSITY OF MINNESOTA · PI BOULWARE, DAVID R, MEYA, DAVID BISAGAYA · 2019 to 2022
$2.6M
Evaluation of CRAG screening with enhanced antifungal therapy for asymptomatic CRAG-positive personsK23AI138851 · NIAID · UNIVERSITY OF MINNESOTA · PI RAJASINGHAM, RADHA · 2018 to 2022
$954k
Evaluating Antiretroviral Pharmacology in the Female Genital Tract to Optimize HIV PreventionK08AI134262 · NIAID · UNIVERSITY OF MINNESOTA · PI NICOL, MELANIE RAE · 2018 to 2022
$847k
Neuroinflammation and Modulating Factors in Depression and HIVK23MH121220 · NIMH · UNIVERSITY OF MINNESOTA · PI LOFGREN, SARAH · 2019 to 2022
$795k
Medical Student Summer Research Program in Infection and ImmunityT35AI118620 · NIAID · UNIVERSITY OF MINNESOTA · PI MUELLER, DANIEL L · 2015 to 2025
$351k
FIC NIH HHS L30 TW011500NCATS NIH HHS UL1 TR002494NIAID NIH HHS K08 AI134262NIAID NIH HHS K23 AI138851NIAID NIH HHS T32 AI055433NIAID NIH HHS T35 AI118620NIMH NIH HHS K23 MH121220NINDS NIH HHS R01 NS110519
6 · The paper itself

Abstract

backgroundNo effective oral therapy exists for early coronavirus disease 2019 (COVID-19).

objectiveTo investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.

designRandomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).

settingInternet-based trial across the United States and Canada (40 states and 3 provinces).

participantsSymptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.

interventionOral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. MEASUREMENTS: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.

resultsOf 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; LIMITATION: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.

conclusionHydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. PRIMARY FUNDING SOURCE: Private donors.

Indexed as

BetacoronavirusOutpatientsPandemicsAdultAntimalarialsCoronavirus InfectionsCOVID-19Double-Blind MethodFemaleFollow-Up StudiesHumansHydroxychloroquineMaleMiddle AgedPneumonia, ViralRetrospective StudiesAntimalarialsHydroxychloroquine

Identifiers

PMID32673060
PMCPMC7384270
OpenAlexW3043308024

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.