Trial Outcomes & Findings for Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection (NCT NCT04339426)
NCT ID: NCT04339426
Last Updated: 2026-06-29
Results Overview
Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
10 days
Results posted on
2026-06-29
Participant Flow
Participant milestones
| Measure |
Atovaquone/Azithromycin
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Atovaquone/Azithromycin
n=3 Participants
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 10 daysVirology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing.
Outcome measures
| Measure |
Atovaquone/Azithromycin
n=2 Participants
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Virology Cure Rate
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 47 daysMeasured incidence of diarrhea, vomiting, nausea, and constipation.
Outcome measures
| Measure |
Atovaquone/Azithromycin
n=2 Participants
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Incidence of Gastrointestinal Adverse Events
Diarrhea · Diarrhea
|
0 Number of participants affected by GI AE
|
|
Incidence of Gastrointestinal Adverse Events
Vomiting · Diarrhea
|
0 Number of participants affected by GI AE
|
|
Incidence of Gastrointestinal Adverse Events
Nausea · Diarrhea
|
0 Number of participants affected by GI AE
|
|
Incidence of Gastrointestinal Adverse Events
Constipation · Diarrhea
|
1 Number of participants affected by GI AE
|
SECONDARY outcome
Timeframe: 10 daysCardiac toxicity measured by 12-lead electrocardiogram (ECG) daily if QTc \>500 msec. The number of QTc \>500 msec events after beginning study regimen is reported here.
Outcome measures
| Measure |
Atovaquone/Azithromycin
n=2 Participants
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Cardiac Toxicity
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 daysPopulation: n=1 did not have WBC data for days 2 and 4.
Measurement of change in number of white blood cells (WBCs) throughout the course of COVID-19 infection.
Outcome measures
| Measure |
Atovaquone/Azithromycin
n=2 Participants
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Change in White Blood Cells Over Time
Day 0 (before study regimen)
|
4.00 cells*10^3/uL
Interval 3.6 to 4.4
|
|
Change in White Blood Cells Over Time
Day 1
|
4.05 cells*10^3/uL
Interval 3.3 to 4.8
|
|
Change in White Blood Cells Over Time
Day 2
|
3.00 cells*10^3/uL
Interval 3.0 to 3.0
|
|
Change in White Blood Cells Over Time
Day 3
|
6.25 cells*10^3/uL
Interval 5.3 to 7.2
|
|
Change in White Blood Cells Over Time
Day 4
|
4.80 cells*10^3/uL
Interval 4.8 to 4.8
|
|
Change in White Blood Cells Over Time
Day 5
|
6.20 cells*10^3/uL
Interval 4.2 to 8.2
|
|
Change in White Blood Cells Over Time
Day 6
|
7.50 cells*10^3/uL
Interval 5.1 to 9.9
|
|
Change in White Blood Cells Over Time
Day 7
|
8.60 cells*10^3/uL
Interval 7.3 to 9.9
|
|
Change in White Blood Cells Over Time
Day 8
|
8.65 cells*10^3/uL
Interval 8.3 to 9.0
|
|
Change in White Blood Cells Over Time
Day 9
|
8.80 cells*10^3/uL
Interval 8.6 to 9.0
|
|
Change in White Blood Cells Over Time
Day 10
|
8.35 cells*10^3/uL
Interval 7.1 to 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 daysPopulation: All participants did not have reliable lymphocyte readings on day 0 (prior to study regimen start), therefore day 0 was removed from the analysis. n=1 did not have lymphocyte data for days 2 and 4.
Measurement of change in number of lymphocytes throughout the course of COVID-19 infection.
Outcome measures
| Measure |
Atovaquone/Azithromycin
n=2 Participants
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Change in Lymphocytes Over Time
Day 1
|
1.370 cells*10^3/uL
Interval 1.2 to 1.54
|
|
Change in Lymphocytes Over Time
Day 2
|
1.100 cells*10^3/uL
Interval 1.1 to 1.1
|
|
Change in Lymphocytes Over Time
Day 3
|
0.960 cells*10^3/uL
Interval 0.7 to 1.22
|
|
Change in Lymphocytes Over Time
Day 4
|
0.800 cells*10^3/uL
Interval 0.8 to 0.8
|
|
Change in Lymphocytes Over Time
Day 5
|
0.810 cells*10^3/uL
Interval 0.8 to 0.82
|
|
Change in Lymphocytes Over Time
Day 6
|
1.025 cells*10^3/uL
Interval 1.0 to 1.05
|
|
Change in Lymphocytes Over Time
Day 7
|
0.850 cells*10^3/uL
Interval 0.7 to 1.0
|
|
Change in Lymphocytes Over Time
Day 8
|
0.865 cells*10^3/uL
Interval 0.8 to 0.93
|
|
Change in Lymphocytes Over Time
Day 9
|
0.625 cells*10^3/uL
Interval 0.35 to 0.9
|
|
Change in Lymphocytes Over Time
Day 10
|
0.860 cells*10^3/uL
Interval 0.72 to 1.0
|
Adverse Events
Atovaquone/Azithromycin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atovaquone/Azithromycin
n=2 participants at risk
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Atovaquone/Azithromycin: Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Nervous system disorders
Encephalopathy
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Injury, poisoning and procedural complications
Fracture
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Cardiac disorders
Tachycardia
|
100.0%
2/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Skin and subcutaneous tissue disorders
Facial skin trauma
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Vascular disorders
Edema limbs
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Eye disorders
Conjunctivitis
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
|
Infections and infestations
Klebsiella bacteremia
|
50.0%
1/2 • From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place