Trial Outcomes & Findings for Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 (NCT NCT04358068)
NCT ID: NCT04358068
Last Updated: 2021-11-16
Results Overview
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
The 20-day period from and including the day of the first dose of study treatment
Results posted on
2021-11-16
Participant Flow
Participants were enrolled between 13MAY2020 and 15JUN2020 at US based clinical research sites
Participant milestones
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Overall Study
Did not initiate study treatment
|
2
|
2
|
Baseline Characteristics
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
Baseline characteristics by cohort
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
35 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Age, Customized
< 60 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
>= 60 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Risk of progression to severe disease
High risk
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Risk of progression to severe disease
Low risk
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Time from symptom onset to treatment start
|
5 days
n=5 Participants
|
4 days
n=7 Participants
|
5 days
n=5 Participants
|
PRIMARY outcome
Timeframe: The 20-day period from and including the day of the first dose of study treatmentPopulation: Participants who initiated study treatment
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Number of Participants Who Died From Any Cause or Were Hospitalized
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The 20-day period from and including the day of the first dose of study treatmentPopulation: Participants who initiated study treatment
Deaths reported due to any cause (COVID-related or not)
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Number of Participants Who Died From Any Cause
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The 20-day period from and including the day of the first dose of study treatmentPopulation: Participants who initiated study treatment
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization, but was included for this outcome measure.
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Number of Participants Who Died From Any Cause, or Were Hospitalized, or Had an Urgent Visit to Emergency Room or Clinic
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From day of the first dose of study treatment to Week 24Population: Due to the early termination of the study, the data were not collected
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Due to the early termination of the study, participant followup was discontinued at Day 20. Refer to the primary outcome above for results based on the time frame out to Day 20.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study treatment through Day 7Population: Participants who initiated study treatment
Premature discontinuation of study treatment is defined as a permanent discontinuation of either study treatment (HCQ/Placebo and/or Azithro/Placebo)
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Number of Participants Who Prematurely Discontinue Study Treatment Due to an Adverse Event
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment through Day 20Population: Participants who initiated study treatment
Cardiac adverse events included in the analysis were chosen a priori by the study chairs
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Number of Participants Who Had Any Cardiac Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 20, 21 days totalPopulation: Participants who initiated study treatment and reported at least one temperature on the diary card
Defined as the time from study treatment initiation to the last day in the participant's daily diary card on which a temperature greater than 100.4°F was recorded or a potentially antipyretic drug, such as acetaminophen or ibuprofen, was taken. Participants with at least one temperature who never reported fever or use of anti-pyretic medications were assigned a duration of zero days
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=8 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Duration of Fever
|
0 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 20, 21 days totalPopulation: Participants who initiated study treatment
Defined as the time from start of study treatment to the last day in the participant's daily diary card on which a moderate or worse targeted symptom was recorded. The set of target symptoms were cough, shortness of breath, feeling feverish, fatigue, muscle aches, diarrhea, vomiting, nausea, headache, sore throat, nasal obstruction (stuffy nose), nasal discharge (runny nose), loss of smell, and loss of taste. Participants who had missing diary records due to hospitalization were assumed to have moderate symptoms during the period of hospitalization in the analysis. Missing diary card records not due to hospitalization were assumed to have absent symptoms.
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Duration of Symptoms Associated With COVID-19 Disease
|
11.0 days
Interval 5.0 to 17.0
|
10.0 days
Interval 5.0 to 21.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 20, 21 days totalPopulation: Participants who initiated study treatment
Defined as the sum of scores for the targeted symptoms (defined in the protocol) in the participant's daily diary record (each symptom was scored from 0-best to 3-worst). Participant-specific areas under the curve (AUC) over time were calculated using the trapezoidal rule and defined as the area below the line formed by joining total symptom scores on each daily diary card from the pre-treatment score on Day 0 through to Day 20. AUCs were rescaled by time by dividing by 21 (corresponding to the number of daily diary cards during follow-up between pre-treatment Day 0 and Day 20), in order to provide results on a symptom scale from 0-best to 42-worst (for non-hospitalized participants). Participants who were hospitalized were assigned a value equal to the sum of the maximum possible scaled AUC (42) and the duration of hospitalization, and thus values \>42 were possible. Missing scores between pre-treatment and Day 20 were linearly interpolated. Higher AUCs indicate worse outcomes.
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Participant-specific Area Under the Curve (AUC) of the Symptom Score Associated With COVID-19 Disease Over Time
|
4.0 score on a scale
Interval 0.9 to 18.0
|
2.8 score on a scale
Interval 0.5 to 46.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 20, 21 days totalPopulation: Participants who initiated study treatment
Time to self-reported return to (pre-COVID) usual health was defined as the time from the start of study treatment to the first day in the participant's daily diary card on which they responded 'Yes' with no subsequent reports of 'No' to the question "Have you returned to your usual (pre-COVID) health today?" Participants who never reported a 'Yes' response were assigned a duration of 22 days.
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Time to Self-reported Return to Usual (Pre-COVID) Health.
|
17.0 days
Interval 6.0 to 22.0
|
10.0 days
Interval 6.0 to 22.0
|
SECONDARY outcome
Timeframe: Measured at entry, Day 6, and Day 20Population: The virology substudy did not open to enrollment and thus no data on virologic outcomes are available
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at entry, Day 6, and Day 20Population: The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study treatment through Day 20Population: Participants who initiated study treatment
Fainting was self-reported on the study diary card as absent (score 0), mild (1), moderate (2), or severe (3); scores of \> 0 are defined as an occurrence of fainting
Outcome measures
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=7 Participants
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=9 Participants
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Number of Participants With an Occurrence of Fainting
|
1 Participants
|
1 Participants
|
Adverse Events
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B: Placebo for Hydroxychloroquine and Azithromycin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=9 participants at risk
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=11 participants at risk
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
Other adverse events
| Measure |
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
n=9 participants at risk
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Hydroxychloroquine (HCQ): Administered orally
Azithromycin (Azithro): Administered orally
|
Arm B: Placebo for Hydroxychloroquine and Azithromycin
n=11 participants at risk
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Placebo for Hydroxychloroquine: Administered orally
Placebo for Azithromycin: Administered orally
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
0.00%
0/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
0.00%
0/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
0.00%
0/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Nervous system disorders
Ageusia
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Nervous system disorders
Anosmia
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
18.2%
2/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
0.00%
0/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/9 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
9.1%
1/11 • From enrollment to the end of follow up (Participants were asked to complete the Day 20 visit and then were discontinued from the study)
Post-entry adverse event (AE) reporting requirements were: All Grade ≥3 AEs; All cardiac AEs regardless of grade; All AEs that led to a change in study treatment/intervention regardless of grade; All AEs meeting SAE definition or EAE reporting requirement. DAIDS AE Grading Table, Version 2.1 and DAIDS EAE Manual Version 2.0 were used for this study.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place