Trial · NCT04308668

Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2

NCT04308668, Phase 3, Completed, University of Minnesota; results first posted 2021-05-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2. Trials, record NCT04308668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04308668

On this page

Trial

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

Title: Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
NCT number: NCT04308668
Status: Completed
Phases: Phase 3
Enrollment: 1,312 participants, actual
Lead sponsor: University of Minnesota
Conditions: Corona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection, Coronavirus, Coronavirus Infections
Interventions: Hydroxychloroquine, Placebo
First posted: 2020-03-16
Last updated: 2021-05-13
Results first posted: 2021-05-13

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline	14 days	Number of participants at 14 days post enrollment with active COVID19 disease among those who were asymptomatic at baseline.
Primary	Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline	baseline and 14 days	Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Secondary	Rate of Hospitalization	14 days	Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Secondary	Rate of Death	Approximately 30 days	Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease through study completion of 14 days. For those hospitalized within the 14-day study period, the protocol specified follow up would occur for up to 90 days to capture the final outcome of participants' hospitalization. Approximately 30-days was the maximal follow up for hospitalization outcome needed in the trial.
Secondary	Rate of Confirmed SARS-CoV-2 Detection	14 days	Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.
Secondary	Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)	14 days	Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID-19 infection.
Secondary	Rate of All-Cause Study Medicine Discontinuation or Withdrawal	14 days	Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Secondary	Overall Symptom Severity at 5 and 14 Days	5 and 14 days	Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Secondary	Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry	14 days	Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the number of participants who report a score of 3.

Source ClinicalTrials.gov

Outcomes9

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 Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline	14 days		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline	baseline and 14 days		score on a scale	MEAN
SECONDARY	Rate of Hospitalization	14 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Death	Approximately 30 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Confirmed SARS-CoV-2 Detection	14 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)	14 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of All-Cause Study Medicine Discontinuation or Withdrawal	14 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Symptom Severity at 5 and 14 Days	5 and 14 days	Early preemptive treatment trial (n=423 symptomatic participants with data)	score on a scale	MEAN
SECONDARY	Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry	14 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline	Treatment	49		Participants
Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline	Placebo	58		Participants
Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline	Treatment	-2.6	Standard Error .12	score on a scale
Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline	Placebo	-2.33	Standard Error .12	score on a scale
Rate of Hospitalization	Treatment	5		Participants
Rate of Hospitalization	Placebo	9		Participants
Rate of Death	Treatment	1		Participants
Rate of Death	Placebo	1		Participants
Rate of Confirmed SARS-CoV-2 Detection	Treatment	11		Participants
Rate of Confirmed SARS-CoV-2 Detection	Placebo	9		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment	658
Overall Study	STARTED	Placebo	654
Overall Study	COMPLETED	Treatment	622
Overall Study	COMPLETED	Placebo	612
Overall Study	NOT COMPLETED	Treatment	36
Overall Study	NOT COMPLETED	Placebo	42

Source ClinicalTrials.gov

Adverse events30

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
other	Nausea or upset stomach	Gastrointestinal disorders	Treatment	146	658	146
other	Nausea or upset stomach	Gastrointestinal disorders	Placebo	53	654	53
other	Diarrhea, abdominal pain, vomiting	Gastrointestinal disorders	Treatment	131	658	131
other	Diarrhea, abdominal pain, vomiting	Gastrointestinal disorders	Placebo	35	654	35
other	Irritability, dizziness, vertigo	General disorders	Treatment	39	658	39
other	Irritability, dizziness, vertigo	General disorders	Placebo	26	654	26
other	Tinnitus	Ear and labyrinth disorders	Treatment	16	658	16
other	Tinnitus	Ear and labyrinth disorders	Placebo	8	654	8
other	Headache	General disorders	Treatment	15	658	15
other	Headache	General disorders	Placebo	8	654	8

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment	1	658
Total, all-cause mortality	Placebo	1	654
Total, other adverse events	Treatment	367	658
Total, other adverse events	Placebo	148	654
Total, serious adverse events	Treatment	6	658
Total, serious adverse events	Placebo	11	654

Source ClinicalTrials.gov

Papers12

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32344449	BACKGROUND	PubMed
32345336	BACKGROUND	PubMed
32363212	BACKGROUND	PubMed
32383125	BACKGROUND	PubMed
32492293	RESULT	PubMed
32668109	BACKGROUND	PubMed
32673060	RESULT	PubMed
33204764	RESULT	PubMed
33274360	RESULT	PubMed
33553471	BACKGROUND	PubMed

1 to 10 of 12

See all 12 papers

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 comparisons9

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

Comparison	Source
Treatment vs Placebo: Rate of All-Cause Study Medicine Discontinuation or Withdrawal	Trial comparisons
Treatment vs Placebo: Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)	Trial comparisons
Treatment vs Placebo: Rate of Confirmed SARS-CoV-2 Detection	Trial comparisons
Treatment vs Placebo: Rate of Death	Trial comparisons
Treatment vs Placebo: Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry	Trial comparisons
Treatment vs Placebo: Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline	Trial comparisons
Treatment vs Placebo: deaths from any cause	Trial comparisons
Treatment vs Placebo: Rate of Hospitalization	Trial comparisons
Treatment 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.

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/NCT04308668

GET https://conductscience.org/api/trials/v1/NCT04308668/events?page=2

API reference For AI assistants