Trial · NCT04334148
Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
NCT04334148, Phase 3, Completed, Adrian Hernandez; results first posted 2021-10-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine. Trials, record NCT04334148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04334148
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
- NCT number
- NCT04334148
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,360 participants, actual
- Lead sponsor
- Adrian Hernandez
- Conditions
- COVID-19
- Interventions
- Hydroxychloroquine, Placebo oral tablet
- First posted
- 2020-04-06
- Last updated
- 2021-10-12
- Results first posted
- 2021-10-07
- Limitations and caveats
The study was underpowered to detect a small treatment effect. The trial was novel and improved feasibility, particularly during a pandemic. Testing was not performed at all institutions per local policies in HCW. These events were defined as suspected cases and were combined with the confirmed cases in the primary outcome. This resulted in few confirmed COVID-19 infections; thus, our primary outcome was primarily suspected COVID-19 clinical infection.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Infection With COVID-19 Infection | 30 days | This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies. |
| Secondary | Number of Participants With COVID-19 Viral Shedding | 30 days | Number of participants with COVID-19 infection shedding via Covance swab PCR testing |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs) | 30 days | Safety and Tolerability as determined by subject reported serious adverse events (SAEs) and hydroxychloroquine-associated events of special interest. EOSIs include: arrhythmias (ventricular), hepatic failure, bone marrow failure, aplastic anemia, prolonged QT interval, angioedema, dermatitis exfoliative, acute generalized exanthematous pustulosis, psychosis, suicidal ideation, seizure, methemoglobinemia. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Infection With COVID-19 Infection | 30 days | Participants who completed the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With COVID-19 Viral Shedding | 30 days | Participants who completed the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs) | 30 days | Participants who completed the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Infection With COVID-19 Infection | Hydroxychloroquine | 41 | Participants | ||
| Number of Participants With Clinical Infection With COVID-19 Infection | Placebo | 53 | Participants | ||
| Number of Participants With COVID-19 Viral Shedding | Hydroxychloroquine | 2 | Participants | ||
| Number of Participants With COVID-19 Viral Shedding | Placebo | 2 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs) | Hydroxychloroquine | 7 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs) | Placebo | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxychloroquine | 683 | |
| Overall Study | STARTED | Placebo | 677 | |
| Overall Study | COMPLETED | Hydroxychloroquine | 683 | |
| Overall Study | COMPLETED | Placebo | 676 | |
| Overall Study | NOT COMPLETED | Hydroxychloroquine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute Myocardial Infarction | Cardiac disorders | Hydroxychloroquine | 1 | 683 | 1 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Placebo | 0 | 677 | 0 |
| serious | Anxiety | Psychiatric disorders | Hydroxychloroquine | 0 | 683 | 0 |
| serious | Anxiety | Psychiatric disorders | Placebo | 1 | 677 | 1 |
| serious | Suicide attempt | Psychiatric disorders | Hydroxychloroquine | 1 | 683 | 1 |
| serious | Suicide attempt | Psychiatric disorders | Placebo | 0 | 677 | 0 |
| serious | Alcohol Use Disorder | Psychiatric disorders | Hydroxychloroquine | 1 | 683 | 1 |
| serious | Alcohol Use Disorder | Psychiatric disorders | Placebo | 0 | 677 | 0 |
| serious | Haematuria | Hepatobiliary disorders | Hydroxychloroquine | 1 | 683 | 1 |
| serious | Haematuria | Hepatobiliary disorders | Placebo | 0 | 677 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxychloroquine | 0 | 683 |
| Total, all-cause mortality | Placebo | 0 | 677 |
| Total, other adverse events | Hydroxychloroquine | 0 | 683 |
| Total, other adverse events | Placebo | 0 | 677 |
| Total, serious adverse events | Hydroxychloroquine | 3 | 683 |
| Total, serious adverse events | Placebo | 2 | 677 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36682681 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hydroxychloroquine vs Placebo: Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs) | Trial comparisons |
| Hydroxychloroquine vs Placebo: Number of Participants With Clinical Infection With COVID-19 Infection | Trial comparisons |
| Hydroxychloroquine vs Placebo: deaths from any cause | Trial comparisons |
| Hydroxychloroquine vs Placebo: Number of Participants With COVID-19 Viral Shedding | Trial comparisons |
| Hydroxychloroquine vs Placebo: serious adverse events | Trial comparisons |
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.
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/NCT04334148
GET https://conductscience.org/api/trials/v1/NCT04334148/registered