Trial Outcomes & Findings for Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (NCT NCT04329832)

Last Updated: 2022-04-20

Results Overview

Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

Assessed once on day 14 after enrollment (enrollment is day 0)

Results posted on

2022-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Hydroxychloroquine Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \< 45 kg or GFR (glomerular filtration rate)\<50ml/min). For patients \< 45kg, doses will be halved. For patients with GFR\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.	Azithromycin Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
Overall Study STARTED	42	43
Overall Study COMPLETED	42	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine n=42 Participants Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \< 45 kg or GFR (glomerular filtration rate)\<50ml/min). For patients \< 45kg, doses will be halved. For patients with GFR\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.	Azithromycin n=43 Participants Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.	Total n=85 Participants Total of all reporting groups
Age, Continuous	51 years n=93 Participants	58 years n=4 Participants	55 years n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	14 Participants n=4 Participants	33 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	29 Participants n=4 Participants	52 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=93 Participants	28 Participants n=4 Participants	53 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	26 Participants n=93 Participants	28 Participants n=4 Participants	54 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	42 participants n=93 Participants	43 participants n=4 Participants	85 participants n=27 Participants
Comorbidities	1 Scores on a scale n=93 Participants	0 Scores on a scale n=4 Participants	1 Scores on a scale n=27 Participants

PRIMARY outcome

Timeframe: Assessed once on day 14 after enrollment (enrollment is day 0)

Outcome measures

Outcome measures
Measure	Day 14 WHO COVID Score: Hydroxychloroquine n=42 Participants The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm	Day 14 WHO COVID Score: Azithromycin n=43 Participants The median WHO COVID Score at Day 14 for patients in the azithromycin arm
COVID Ordinal Outcomes Scale at 14 Days	2.0 score on a scale Interval 2.0 to 3.75	2.0 score on a scale Interval 1.5 to 3.0

SECONDARY outcome

Timeframe: Admission (day 1) to 28 days after admission (day 28)

Calculated as number of days patient not in hospital

Outcome measures

Outcome measures
Measure	Day 14 WHO COVID Score: Hydroxychloroquine n=42 Participants The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm	Day 14 WHO COVID Score: Azithromycin n=43 Participants The median WHO COVID Score at Day 14 for patients in the azithromycin arm
Hospital-free Days at 28 Days	18.5 Days Interval 7.25 to 24.75	21 Days Interval 7.5 to 24.0

SECONDARY outcome

Timeframe: Admission (day 1) to 28 days after admission (day 28)

Calculated as number of days that patient is not on a ventilator up to day 28 days after admission

Outcome measures

Outcome measures
Measure	Day 14 WHO COVID Score: Hydroxychloroquine n=42 Participants The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm	Day 14 WHO COVID Score: Azithromycin n=43 Participants The median WHO COVID Score at Day 14 for patients in the azithromycin arm
Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)	18 days Interval 10.75 to 18.0	18 days Interval 12.0 to 18.0

SECONDARY outcome

Timeframe: Admission (day 1) to 28 days after admission (day 28)

Calculated as number of days patient not in an ICU

Outcome measures

Outcome measures
Measure	Day 14 WHO COVID Score: Hydroxychloroquine n=42 Participants The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm	Day 14 WHO COVID Score: Azithromycin n=43 Participants The median WHO COVID Score at Day 14 for patients in the azithromycin arm
ICU-free Days at 28 Days	18 Days Interval 8.0 to 22.0	19 Days Interval 8.5 to 22.0

SECONDARY outcome

Timeframe: Admission (day 1) to 14 days after admission (day 14)

Time to 1-point decrease in the WHO ordinal recovery score is defined as the number of days until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale, which reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

Outcome measures

Outcome measures
Measure	Day 14 WHO COVID Score: Hydroxychloroquine n=42 Participants The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm	Day 14 WHO COVID Score: Azithromycin n=43 Participants The median WHO COVID Score at Day 14 for patients in the azithromycin arm
Time to a 1-point Decrease in the WHO Ordinal Recovery Score	7 Days Interval 3.0 to 13.0	6 Days Interval 2.5 to 10.0

Adverse Events

Hydroxychloroquine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 6 deaths

Azithromycin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hydroxychloroquine n=42 participants at risk Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \< 45 kg or GFR (glomerular filtration rate)\<50ml/min). For patients \< 45kg, doses will be halved. For patients with GFR\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.	Azithromycin n=43 participants at risk Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
Cardiac disorders QT Prolongation	7.1% 3/42 • Number of events 3 • Hospital discharge of the specific subject. Median length of stay for patients in both arms is 7.8 days. Upper bound of IQR for Hydroxychloroquine arm is 15.55 days and upper bound of IQR for Azithromycin arm is 20.85 days.	4.7% 2/43 • Number of events 2 • Hospital discharge of the specific subject. Median length of stay for patients in both arms is 7.8 days. Upper bound of IQR for Hydroxychloroquine arm is 15.55 days and upper bound of IQR for Azithromycin arm is 20.85 days.

Additional Information

Naresh Kumar

Intermountain Healthcare

Phone: 8013827483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place