Trial Outcomes & Findings for Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (NCT NCT04334148)

Last Updated: 2021-10-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1360 participants

Primary outcome timeframe

30 days

Results posted on

2021-10-12

Participant Flow

A participant was excluded from analysis population if they had a positive nasal swab test at baseline visit. This occurred to 1 participant assigned to the placebo group.

Participant milestones

Participant milestones
Measure	Hydroxychloroquine Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo Matching placebo tablets Placebo oral tablet: oral self administered tablet
Overall Study STARTED	683	677
Overall Study COMPLETED	683	676
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydroxychloroquine Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo Matching placebo tablets Placebo oral tablet: oral self administered tablet
Overall Study positive nasal swab at baseline	0	1

Baseline Characteristics

Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine n=683 Participants Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo n=676 Participants Matching placebo tablets Placebo oral tablet: oral self administered tablet	Total n=1359 Participants Total of all reporting groups
Age, Continuous	44.2 years STANDARD_DEVIATION 11.9 • n=93 Participants	43.1 years STANDARD_DEVIATION 11.2 • n=4 Participants	43.6 years STANDARD_DEVIATION 11.6 • n=27 Participants
Sex: Female, Male Female	442 Participants n=93 Participants	446 Participants n=4 Participants	888 Participants n=27 Participants
Sex: Female, Male Male	241 Participants n=93 Participants	230 Participants n=4 Participants	471 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=93 Participants	40 Participants n=4 Participants	79 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	639 Participants n=93 Participants	629 Participants n=4 Participants	1268 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Asian	28 Participants n=93 Participants	27 Participants n=4 Participants	55 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Black or African American	18 Participants n=93 Participants	23 Participants n=4 Participants	41 Participants n=27 Participants
Race (NIH/OMB) White	624 Participants n=93 Participants	610 Participants n=4 Participants	1234 Participants n=27 Participants
Race (NIH/OMB) More than one race	6 Participants n=93 Participants	9 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment United States	683 participants n=93 Participants	676 participants n=4 Participants	1359 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Participants who completed the study.

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=683 Participants Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo n=676 Participants Matching placebo tablets Placebo oral tablet: oral self administered tablet
Number of Participants With Clinical Infection With COVID-19 Infection	41 Participants	53 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants who completed the study.

Number of participants with COVID-19 infection shedding via Covance swab PCR testing

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=683 Participants Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo n=676 Participants Matching placebo tablets Placebo oral tablet: oral self administered tablet
Number of Participants With COVID-19 Viral Shedding	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants who completed the study.

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.

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=683 Participants Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo n=676 Participants Matching placebo tablets Placebo oral tablet: oral self administered tablet
Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)	7 Participants	8 Participants

Adverse Events

Hydroxychloroquine

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hydroxychloroquine n=683 participants at risk Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Hydroxychloroquine: oral self administered tablet	Placebo n=677 participants at risk Matching placebo tablets Placebo oral tablet: oral self administered tablet
Cardiac disorders Acute Myocardial Infarction	0.15% 1/683 • Number of events 1 • 60 days	0.00% 0/677 • 60 days
Psychiatric disorders Anxiety	0.00% 0/683 • 60 days	0.15% 1/677 • Number of events 1 • 60 days
Psychiatric disorders Suicide attempt	0.15% 1/683 • Number of events 1 • 60 days	0.00% 0/677 • 60 days
Psychiatric disorders Alcohol Use Disorder	0.15% 1/683 • Number of events 1 • 60 days	0.00% 0/677 • 60 days
Hepatobiliary disorders Haematuria	0.15% 1/683 • Number of events 1 • 60 days	0.00% 0/677 • 60 days
Infections and infestations COVID-19	0.00% 0/683 • 60 days	0.15% 1/677 • Number of events 1 • 60 days
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/683 • 60 days	0.15% 1/677 • Number of events 1 • 60 days

Other adverse events

Adverse event data not reported

Additional Information

Dr. Susanna Naggie

Duke University

Phone: 919-684-2584

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place