Trial Outcomes & Findings for Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection (NCT NCT04341727)
NCT ID: NCT04341727
Last Updated: 2024-04-25
Results Overview
Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death in each Arm/Group,respectively.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
42 days
Results posted on
2024-04-25
Participant Flow
Participant milestones
| Measure |
Hydroxychloroquine Alone
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Hydroxychloroquine Alone
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine Alone
n=9 Participants
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
n=7 Participants
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
n=7 Participants
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
n=7 Participants
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
55 years
n=7 Participants
|
54 years
n=5 Participants
|
56 years
n=4 Participants
|
55 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: The sample size of 30 was well below the threshold for analysis
Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death in each Arm/Group,respectively.
Outcome measures
| Measure |
Hydroxychloroquine Alone
n=9 Participants
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
n=7 Participants
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
n=7 Participants
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
n=7 Participants
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
|---|---|---|---|---|
|
Hours to Recovery
|
96 hours
Interval 24.0 to 168.0
|
120 hours
Interval 48.0 to 240.0
|
168 hours
Interval 72.0 to 672.0
|
240 hours
Interval 48.0 to 288.0
|
SECONDARY outcome
Timeframe: 42 daysPopulation: The sample was well below the threshold for analysis
Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications in each Arm/Group,respectively.
Outcome measures
| Measure |
Hydroxychloroquine Alone
n=9 Participants
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
n=7 Participants
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
n=7 Participants
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
n=7 Participants
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
|---|---|---|---|---|
|
Time to Fever Resolution
|
72 hours
Interval 24.0 to 96.0
|
96 hours
Interval 48.0 to 120.0
|
72 hours
Interval 24.0 to 192.0
|
96 hours
Interval 48.0 to 144.0
|
Adverse Events
Hydroxychloroquine Alone
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Hydroxychloroquine Plus Azithromycin
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Chloroquine Alone
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Chloroquine Plus Azithromycin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxychloroquine Alone
n=9 participants at risk
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
n=7 participants at risk
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
n=7 participants at risk
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
n=7 participants at risk
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia due to COVID
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Infections and infestations
Urosepsis
|
0.00%
0/9 • 6 weeks per participant
|
14.3%
1/7 • Number of events 4 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure secondary to COVID
|
0.00%
0/9 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Vascular disorders
Deep Vein Thrombosis-
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure secondary to Covid
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Infections and infestations
Bacterial Pneumonia
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
Other adverse events
| Measure |
Hydroxychloroquine Alone
n=9 participants at risk
Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
|
Hydroxychloroquine Plus Azithromycin
n=7 participants at risk
Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
Hydroxychloroquine Sulfate: anti-rheumatic drug (DMARD)
Azithromycin: Antibiotic
|
Chloroquine Alone
n=7 participants at risk
Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
Chloroquine Sulfate: Antimalarial
|
Chloroquine Plus Azithromycin
n=7 participants at risk
Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
Azithromycin: Antibiotic
Chloroquine Sulfate: Antimalarial
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Infections and infestations
Urinary Tract infection
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia due to COVID
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Cardiac disorders
Prolonged QtC
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
|
Nervous system disorders
Blurred Vision
|
11.1%
1/9 • Number of events 2 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure due to Covid
|
0.00%
0/9 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/9 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 2 • 6 weeks per participant
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
|
Renal and urinary disorders
Acute Kidney Injury
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Endocrine disorders
Hypernatremia
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Coagulopathy
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Cardiac disorders
Prolonged QTc
|
0.00%
0/9 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
14.3%
1/7 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
|
Cardiac disorders
Chest Pain
|
11.1%
1/9 • Number of events 1 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
0.00%
0/7 • 6 weeks per participant
|
Additional Information
Jane O'Halloran
Washington University School of Medicine
Phone: 314 454 0058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place