Trial Outcomes & Findings for Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19 (NCT NCT04336332)
NCT ID: NCT04336332
Last Updated: 2023-02-28
Results Overview
Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Baseline and day six
Results posted on
2023-02-28
Participant Flow
Participant milestones
| Measure |
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
* Azithromycin 500 mg taken by mouth on Day 1, followed by
* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.
Hydroxychloroquine Sulfate + Azithromycin: Given PO
Hydroxychloroquine Sulfate: Given PO
|
Arm 2: Hydroxychloroquine Sulfate Alone
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Hydroxychloroquine Sulfate: Given PO
|
Arm 3: Placebo
* Placebo pills Days 1-6.
* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
30
|
29
|
|
Overall Study
COMPLETED
|
16
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Baseline characteristics by cohort
| Measure |
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
n=16 Participants
* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
* Azithromycin 500 mg taken by mouth on Day 1, followed by
* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.
Hydroxychloroquine Sulfate + Azithromycin: Given PO
Hydroxychloroquine Sulfate: Given PO
|
Arm 2: Hydroxychloroquine Sulfate Alone
n=30 Participants
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Hydroxychloroquine Sulfate: Given PO
|
Arm 3: Placebo
n=29 Participants
* Placebo pills Days 1-6.
* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
48 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
29 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
46 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
47 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
30 participants
n=107 Participants
|
29 participants
n=206 Participants
|
75 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline and day sixPopulation: Data were not collected
Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 4 deaths
Arm 2: Hydroxychloroquine Sulfate Alone
Serious events: 1 serious events
Other events: 13 other events
Deaths: 4 deaths
Arm 3: Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
n=16 participants at risk
* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
* Azithromycin 500 mg taken by mouth on Day 1, followed by
* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.
Hydroxychloroquine Sulfate + Azithromycin: Given PO
Hydroxychloroquine Sulfate: Given PO
|
Arm 2: Hydroxychloroquine Sulfate Alone
n=30 participants at risk
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Hydroxychloroquine Sulfate: Given PO
|
Arm 3: Placebo
n=29 participants at risk
* Placebo pills Days 1-6.
* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • The period of time over which adverse event data was collected is after six days.
|
3.3%
1/30 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
3.4%
1/29 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • The period of time over which adverse event data was collected is after six days.
|
0.00%
0/30 • The period of time over which adverse event data was collected is after six days.
|
3.4%
1/29 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
Other adverse events
| Measure |
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
n=16 participants at risk
* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
* Azithromycin 500 mg taken by mouth on Day 1, followed by
* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.
Hydroxychloroquine Sulfate + Azithromycin: Given PO
Hydroxychloroquine Sulfate: Given PO
|
Arm 2: Hydroxychloroquine Sulfate Alone
n=30 participants at risk
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Hydroxychloroquine Sulfate: Given PO
|
Arm 3: Placebo
n=29 participants at risk
* Placebo pills Days 1-6.
* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
31.2%
5/16 • Number of events 6 • The period of time over which adverse event data was collected is after six days.
|
20.0%
6/30 • Number of events 8 • The period of time over which adverse event data was collected is after six days.
|
6.9%
2/29 • Number of events 3 • The period of time over which adverse event data was collected is after six days.
|
|
Investigations
Investigations
|
18.8%
3/16 • Number of events 4 • The period of time over which adverse event data was collected is after six days.
|
20.0%
6/30 • Number of events 11 • The period of time over which adverse event data was collected is after six days.
|
6.9%
2/29 • Number of events 2 • The period of time over which adverse event data was collected is after six days.
|
|
Infections and infestations
Infections and infestations
|
6.2%
1/16 • Number of events 2 • The period of time over which adverse event data was collected is after six days.
|
20.0%
6/30 • Number of events 8 • The period of time over which adverse event data was collected is after six days.
|
3.4%
1/29 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
25.0%
4/16 • Number of events 4 • The period of time over which adverse event data was collected is after six days.
|
3.3%
1/30 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
6.9%
2/29 • Number of events 3 • The period of time over which adverse event data was collected is after six days.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
6.2%
1/16 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
6.7%
2/30 • Number of events 2 • The period of time over which adverse event data was collected is after six days.
|
3.4%
1/29 • Number of events 1 • The period of time over which adverse event data was collected is after six days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place