Azithromycin for COVID-19 Treatment in Outpatients Nationwide (ACTION)

• ClinicalTrials.gov Identifier: NCT04332107
• Recruitment Status: Terminated
• First Posted: April 2, 2020
• Results First Posted: September 9, 2021
• Last Update Posted: March 2, 2023
• Sponsor: Thomas M. Lietman
• Collaborators: Bill and Melinda Gates Foundation; Pfizer; Stanford University
• Information provided by (Responsible Party): Thomas M. Lietman, University of California, San Francisco

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: COVID-19; SARS-CoV-2
• Interventions: Drug: Azithromycin; Drug: Placebos
• Enrollment: 263

Participant Flow

Recruitment Details	Between May 22, 2020 and March 16, 2021, 604 participants were screened and 263 participants were enrolled. All study recruitment and enrollment was done remotely.
Pre-assignment Details	Common reasons for ineligibility included a negative COVID-19 test result (n=70), a COVID-19 test result outside of the 7 day window (n=118), could not be reached for consent (n=73), and under the age of 18 (19). A total of 341 screened participants were excluded.

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Period Title: Day 3
Started	171	92
Completed	145	72
Not Completed	26	20
Reason Not Completed
Lost to Follow-up	23	14
Missing outcome data	3	6
Period Title: Day 14
Started	148 [1]	78 [1]
Completed	131	70
Not Completed	17	8
Reason Not Completed
Lost to Follow-up	13	4
Missing outcome data	4	4
[1] Those who had missing measurements at Day 3 but were not completely lost-to-followup were allowed to continue with the trial.
Period Title: Day 21
Started	135 [1]	74 [1]
Completed	125	72
Not Completed	10	2
Reason Not Completed
Lost to Follow-up	10	2
[1] Those who had missing measurements at Day 14 but were not completely lost-to-followup were allowed to continue with the trial.

Baseline Characteristics

Arm/Group Title		Azithromycin	Placebo	Total
Arm/Group Description		1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo	Total of all reporting groups
Overall Number of Baseline Participants		171	92	263
Baseline Analysis Population Description		A single participant in the Azithromycin group did not have baseline symptom information.
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	171 participants	92 participants	263 participants
		42; (35 to 49)	44; (35 to 51)	43; (35 to 50)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	168 participants	92 participants	260 participants
	Female	117 69.6%	57 62.0%	174 66.9%
	Male	51 30.4%	35 38.0%	86 33.1%
		[1] Measure Analysis Population Description: 3 participants did not provide their gender information
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Non-Hispanic White	Number Analyzed	171 participants	92 participants	263 participants
		94 55.0%	56 60.9%	150 57.0%
Latinx/Hispanic	Number Analyzed	171 participants	92 participants	263 participants
		49 28.7%	27 29.3%	76 28.9%
Non-Hispanic Black	Number Analyzed	171 participants	92 participants	263 participants
		11 6.4%	1 1.1%	12 4.6%
Non-Hispanic Asian	Number Analyzed	171 participants	92 participants	263 participants
		6 3.5%	3 3.3%	9 3.4%
Mixed Race	Number Analyzed	171 participants	92 participants	263 participants
		4 2.3%	3 3.3%	7 2.7%
Non-Hispanic Middle Eastern/Arab	Number Analyzed	171 participants	92 participants	263 participants
		2 1.2%	1 1.1%	3 1.1%
Prefer not to answer	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	0 0.0%	1 0.4%
Not reported (missing)	Number Analyzed	171 participants	92 participants	263 participants
		4 2.3%	0 0.0%	4 1.5%
Non-Hispanic Native American	Number Analyzed	171 participants	92 participants	263 participants
		0 0.0%	1 1.1%	1 0.4%
Geographic region; Measure Type: Count of Participants; Unit of measure: Participants
West	Number Analyzed	171 participants	92 participants	263 participants
		79 46.2%	40 43.5%	119 45.2%
Southeast	Number Analyzed	171 participants	92 participants	263 participants
		38 22.2%	14 15.2%	52 19.8%
Southwest	Number Analyzed	171 participants	92 participants	263 participants
		24 14.0%	16 17.4%	40 15.2%
Midwest	Number Analyzed	171 participants	92 participants	263 participants
		21 12.3%	16 17.4%	37 14.1%
Northeast	Number Analyzed	171 participants	92 participants	263 participants
		9 5.3%	6 6.5%	15 5.7%
Alcohol consumption >3x/week; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		23 13.5%	9 9.8%	32 12.2%
Current cigarette smoker; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		13 7.6%	5 5.4%	18 6.8%
Current marijuana user; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		9 5.3%	6 6.5%	15 5.7%
Current e-cigarette/vaping; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		8 4.7%	2 2.2%	10 3.8%
Current cigar use; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	1 1.1%	2 0.8%
Comorbidities; Measure Type: Count of Participants; Unit of measure: Participants
Asthma	Number Analyzed	171 participants	92 participants	263 participants
		21 12.3%	11 12.0%	32 12.2%
Hypertension	Number Analyzed	171 participants	92 participants	263 participants
		20 11.7%	12 13.0%	32 12.2%
Diabetes	Number Analyzed	171 participants	92 participants	263 participants
		5 2.9%	5 5.4%	10 3.8%
Chronic obstructive pulmonary disease	Number Analyzed	171 participants	92 participants	263 participants
		4 2.3%	0 0.0%	4 1.5%
Chronic kidney disease	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	1 1.1%	2 0.8%
Cancer	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	0 0.0%	1 0.4%
Stroke	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	1 1.1%	2 0.8%
Recent macrolide use (<30 days); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		22 12.9%	11 12.0%	33 12.5%
Recent hydroxychloroquine use (<7 days); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	0 0.0%	1 0.4%
Current medications; Measure Type: Count of Participants; Unit of measure: Participants
ACE/ARB inhibitor	Number Analyzed	171 participants	92 participants	263 participants
		15 8.8%	14 15.2%	29 11.0%
Metformin	Number Analyzed	171 participants	92 participants	263 participants
		4 2.3%	3 3.3%	7 2.7%
Omeprazole	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	1 1.1%	2 0.8%
Tacrolimus	Number Analyzed	171 participants	92 participants	263 participants
		1 0.6%	0 0.0%	1 0.4%
Current vitamin/supplement use; Measure Type: Count of Participants; Unit of measure: Participants
Vitamin D	Number Analyzed	171 participants	92 participants	263 participants
		64 37.4%	37 40.2%	101 38.4%
Vitamin C	Number Analyzed	171 participants	92 participants	263 participants
		61 35.7%	33 35.9%	94 35.7%
Multivitamin	Number Analyzed	171 participants	92 participants	263 participants
		52 30.4%	27 29.3%	79 30.0%
Zinc	Number Analyzed	171 participants	92 participants	263 participants
		49 28.7%	20 21.7%	69 26.2%
Omega-3 fatty acid	Number Analyzed	171 participants	92 participants	263 participants
		14 8.2%	6 6.5%	20 7.6%
Self-reported symptoms; Measure Type: Count of Participants; Unit of measure: Participants
Multiple symptoms	Number Analyzed	171 participants	92 participants	263 participants
		152 88.9%	82 89.1%	234 89.0%
Cough	Number Analyzed	171 participants	92 participants	263 participants
		111 64.9%	61 66.3%	172 65.4%
Fatigue	Number Analyzed	171 participants	92 participants	263 participants
		107 62.6%	55 59.8%	162 61.6%
Fever	Number Analyzed	171 participants	92 participants	263 participants
		87 50.9%	40 43.5%	127 48.3%
Myalgia	Number Analyzed	171 participants	92 participants	263 participants
		82 48.0%	40 43.5%	122 46.4%
Anosmia	Number Analyzed	171 participants	92 participants	263 participants
		80 46.8%	39 42.4%	119 45.2%
Sore throat	Number Analyzed	171 participants	92 participants	263 participants
		71 41.5%	37 40.2%	108 41.1%
Diarrhea	Number Analyzed	171 participants	92 participants	263 participants
		45 26.3%	20 21.7%	65 24.7%
Shortness of breath	Number Analyzed	171 participants	92 participants	263 participants
		45 26.3%	17 18.5%	62 23.6%
Dizziness	Number Analyzed	171 participants	92 participants	263 participants
		39 22.8%	15 16.3%	54 20.5%
Abdominal pain	Number Analyzed	171 participants	92 participants	263 participants
		29 17.0%	12 13.0%	41 15.6%
None	Number Analyzed	171 participants	92 participants	263 participants
		12 7.0%	6 6.5%	18 6.8%
Conjunctivitis	Number Analyzed	171 participants	92 participants	263 participants
		8 4.7%	2 2.2%	10 3.8%
Number of symptoms; Median (Inter-Quartile Range); Unit of measure: Number of symptoms
	Number Analyzed	171 participants	92 participants	263 participants
		5; (3 to 6)	4; (3 to 6)	4; (3 to 6)
Duration of symptoms prior to test; Median (Inter-Quartile Range); Unit of measure: Days
	Number Analyzed	171 participants	92 participants	263 participants
		3; (2 to 4.5)	3; (2 to 4)	3; (2 to 4)
Days between positive test and enrollment; Median (Inter-Quartile Range); Unit of measure: Days
	Number Analyzed	171 participants	92 participants	263 participants
		3; (1 to 5)	2; (1 to 4)	3; (1 to 5)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Were Symptom Free at Day 14
Description	Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

Percentage of participants who were symptom free at day 14 by randomized treatment group, overall and in pre-specified subgroups. Note that a single participant in the Azithromycin group did not have baseline symptom information.

Arm/Group Title		Azithromycin	Placebo
Arm/Group Description:		1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed		131	70
Measure Type: Count of Participants; Unit of Measure: Participants
Overall	Number Analyzed	131 participants	70 participants
		66 50.4%	35 50.0%
Age <= 60 years	Number Analyzed	121 participants	62 participants
		61 50.4%	31 50.0%
Age > 60 years	Number Analyzed	10 participants	8 participants
		5 50.0%	4 50.0%
Asymptomatic at baseline	Number Analyzed	10 participants	4 participants
		9 90.0%	3 75.0%
Symptomatic at baseline	Number Analyzed	120 participants	66 participants
		57 47.5%	32 48.5%

2. Secondary Outcome

Title	Viral Load - Nasal Swab
Description	Viral load by self-collected nasal swab
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and will never be analyzed

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Viral Load - Saliva Swab
Description	Viral load by self-collected saliva swab
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Mortality
Description	All-cause mortality
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

This outcome is based on the 125 participants in the azithromycin group and the 72 participants in the placebo group who completed the trial.

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	125	72
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

5. Secondary Outcome

Title	Adverse Events
Description	Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Adverse events were recorded at day 3 of the trial via an online questionnaire. Other adverse events were recorded in an open text field and included stomach cramps, light headedness, fatigue, ansomia, cough, and painful respiration.

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	145	72
Measure Type: Count of Participants; Unit of Measure: Participants
Diarrhea	60 41.4%	12 16.7%
Nausea	32 22.1%	7 9.7%
Abdominal Pain	25 17.2%	1 1.4%
Vomiting	5 3.4%	2 2.8%
Rash	4 2.8%	2 2.8%
Other	10 6.9%	3 4.2%
None	9 6.2%	45 62.5%

6. Secondary Outcome

Title	Positive SARS-CoV-2 Test - Nasal Swab
Description	Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Positive SARS-CoV-2 Test - Saliva Swab
Description	Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	Positive SARS-CoV-2 Test - Rectal Swab
Description	Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Genetic Macrolide Resistance Determinants
Description	Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Secondary Outcomes Through Day 21
Description	Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21
Time Frame	Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	125	72
Measure Type: Count of Participants; Unit of Measure: Participants
Absence of symptoms	71 56.8%	43 59.7%
Fever	1 0.8%	1 1.4%
Cough	14 11.2%	13 18.1%
Diarrhea	4 3.2%	1 1.4%
Abdominal pain	0 0.0%	1 1.4%
Anosmia	12 9.6%	9 12.5%
Conjunctivitis	2 1.6%	0 0.0%
Sore throat	4 3.2%	4 5.6%
Shortness of breath	16 12.8%	4 5.6%
Myalgia	5 4.0%	3 4.2%
Fatigue	32 25.6%	17 23.6%
Dizziness	6 4.8%	3 4.2%
Other	10 8.0%	9 12.5%

11. Secondary Outcome

Title	Number of Participants With Emergency Room Visits
Description	Number of emergency room visits <24 hours
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

Number of patients who reported emergency room visit information through Day 21

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	125	72
Measure Type: Count of Participants; Unit of Measure: Participants
	18 14.4%	2 2.8%

12. Secondary Outcome

Title	Number of Household Members With COVID-19 (Confirmed or Symptomatic)
Description	Number of household members with confirmed or symptomatic COVID-19 through Day 21
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

Includes the total number of participants from 69 households in the placebo group and 134 households in the azithromycin group

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	522	278
Measure Type: Count of Participants; Unit of Measure: Participants
	33 6.3%	20 7.2%

13. Secondary Outcome

Title	Number of Participants That Died
Description	Deaths within the study
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

Participants that completed the day 21 questionnaire were included in this secondary analysis.

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	125	72
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

14. Secondary Outcome

Title	Number of Participants Reporting Hospitalization
Description	Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment
Time Frame	21 Days

Outcome Measure Data

Analysis Population Description

Number of patients who reported hospitalization information through Day 21

Arm/Group Title	Azithromycin	Placebo
Arm/Group Description:	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
Overall Number of Participants Analyzed	125	72
Measure Type: Count of Participants; Unit of Measure: Participants
	5 4.0%	0 0.0%

Adverse Events

Time Frame	21 days
Adverse Event Reporting Description	Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for >= 24 hours) and/or if they had visited an emergency department or urgent care center.
Arm/Group Title	Azithromycin	Placebo
Arm/Group Description	1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin	Matching placebo Placebos: Participants will be shipped a dose of matching placebo
All-Cause Mortality
	Azithromycin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/145 (0.00%)	0/72 (0.00%)
Serious Adverse Events
	Azithromycin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/145 (0.00%)	0/72 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Azithromycin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	132/145 (91.03%)	25/72 (34.72%)
Gastrointestinal disorders
Diarrhea †	60/145 (41.38%)	12/72 (16.67%)
Nausea †	32/145 (22.07%)	7/72 (9.72%)
Abdominal pain †	25/145 (17.24%)	1/72 (1.39%)
Vomiting †	5/145 (3.45%)	2/72 (2.78%)
Other †	10/145 (6.90%)	3/72 (4.17%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

This trial was terminated early by the DSMC for futility on March 16, 2021. Therefore, we were not able to complete the analysis for all secondary outcomes because funds were returned to the sponsor following the completion of the study.

Please note that the number of participants varies by period as participants could opt to complete some questionnaires but not others. For example, a participant may skip the day 3 questionnaire, but complete the day 14 questionnaire.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Thomas Lietman, Director of the UCSF FI Proctor Foundation
• Organization: University of California, San Francisco FI Proctor Foundation
• Phone: 415-476-1442
• EMail: tom.lietman@ucsf.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oldenburg CE, Pinsky BA, Brogdon J, Chen C, Ruder K, Zhong L, Nyatigo F, Cook CA, Hinterwirth A, Lebas E, Redd T, Porco TC, Lietman TM, Arnold BF, Doan T. Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2021 Aug 10;326(6):490-498. doi: 10.1001/jama.2021.11517.

• Responsible Party: Thomas M. Lietman, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04332107
• Other Study ID Numbers: 20-30504
• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Results First Submitted: August 9, 2021
• Results First Posted: September 9, 2021
• Last Update Posted: March 2, 2023