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Trial · NCT04361461

Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)

NCT04361461, Phase 3, Withdrawn, Apsen Farmaceutica S.A.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19). Trials, record NCT04361461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04361461

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
NCT number
NCT04361461
Status
Withdrawn
Phases
Phase 3
Enrollment
0 participants, actual
Lead sponsor
Apsen Farmaceutica S.A.
Conditions
Coronavirus Infections, SARS-CoV 2, SARS (Severe Acute Respiratory Syndrome), Pulmonary Disease
Interventions
Hydroxychloroquine Sulfate, Hydroxychloroquine Sulfate + Azythromycin
First posted
2020-04-24
Last updated
2026-09-08

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIndividual response rate14 days after randomizationThe individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.
SecondaryAll-cause mortality28 days after randomizationAll-cause mortality rates at Day 28th after randomization
SecondaryDuration of mechanical ventilationbaselineNumber of days that the patient was on mechanical ventilation which was under ventilation from basal line
SecondaryProportion of patients which needed mechanical ventilation during studyhospitalization within 28 daysProportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.
SecondaryWorld Health Organization (WHO) Ordinal scale28 days after inclusion and compared to baseline
The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
SecondaryDuration of hospitalizationhospitalization within 28 daysLength of hospital stay in days for hospitalization
SecondaryRates of drug discontinuationhospitalization within 28 daysRates of drug discontinuation in all causes under study
OtherRates of serious adverse eventsDay 14thRates of serious adverse events

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04361461

GET https://conductscience.org/api/trials/v1/NCT04361461/registered