Trial Outcomes & Findings for Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers (NCT NCT04333225)

NCT ID: NCT04333225

Last Updated: 2021-08-20

Results Overview

Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 221 participants
• Primary outcome timeframe: Up to 7 weeks after study initiation
• Results posted on: 2021-08-20

Participant Flow

All study subjects were employed by and worked at the Baylor University Medical Center in Dallas, Texas.

Participant milestones

Measure	Hydroxychloroquine Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks	Control Subjects who declined taking HCQ were considered as controls
Overall Study STARTED	101	120
Overall Study COMPLETED	98	115
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

Baseline characteristics by cohort

Measure	Hydroxychloroquine n=101 Participants Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks	Control n=120 Participants Subjects who declined taking HCQ were considered as controls	Total n=221 Participants Total of all reporting groups
Age, Continuous	39.90 Years STANDARD_DEVIATION 12.42 • n=5 Participants	34.53 Years STANDARD_DEVIATION 800 • n=7 Participants	35.36 Years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	101 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	19 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	26 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=5 Participants	94 Participants n=7 Participants	179 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	78 Participants n=5 Participants	104 Participants n=7 Participants	182 Participants n=5 Participants
Race/Ethnicity, Customized Others	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants	120 participants n=7 Participants	221 participants n=5 Participants
Cough score	2.74 Millimeters STANDARD_DEVIATION 7.66 • n=5 Participants	3.26 Millimeters STANDARD_DEVIATION 7.46 • n=7 Participants	3.02 Millimeters STANDARD_DEVIATION 7.54 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 weeks after study initiation

Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial

Outcome measures

Measure	Hydroxychloroquine n=101 Participants Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks	Control n=120 Participants Subjects who declined taking HCQ were considered as controls
Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial	13 Participants	32 Participants

SECONDARY outcome

Timeframe: Up to 7 weeks after study initiation

Time-to-first clinical event consisting of a persistent change for any of the following:

• diagnosis of COVID-19
• clinical characteristics of COVID-19 like illness
• being censored

Outcome measures

Measure	Hydroxychloroquine n=101 Participants Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks	Control n=120 Participants Subjects who declined taking HCQ were considered as controls
Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored	43.17 Days Standard Deviation 11.15	39.25 Days Standard Deviation 15.02

Adverse Events

Hydroxychloroquine

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hydroxychloroquine n=101 participants at risk Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks	Control n=120 participants at risk Subjects who declined taking HCQ were considered as controls
Infections and infestations COVID-19 like illness	0.99% 1/101 • Number of events 1 • 7 weeks	0.00% 0/120 • 7 weeks

Other adverse events

Measure	Hydroxychloroquine n=101 participants at risk Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks	Control n=120 participants at risk Subjects who declined taking HCQ were considered as controls
Gastrointestinal disorders Nausea	12.9% 13/101 • Number of events 21 • 7 weeks	0.00% 0/120 • 7 weeks
Gastrointestinal disorders Diarrhea	7.9% 8/101 • Number of events 21 • 7 weeks	0.00% 0/120 • 7 weeks

Additional Information

Peter A. McCullough, MD, MPH

Baylor Scott & White Research Institute

Phone: 2148412000

Email: peteramccullough@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place