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Futility
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Pfizer | INDUSTRY |
| Stanford University | OTHER |
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This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.
Identification of a safe, effective treatment for individuals with mild or moderate COVID-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. High dose hydroxychloroquine is being evaluated for SARS-CoV-2 prevention and COVID-19 disease treatment, but has a high risk of a number of potentially severe adverse events. Recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. Here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of COVID-19.
Potential participants will undergo remote eligibility screening with study staff prior to enrollment. Upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. At the end of the study (21 days), participants will be emailed a final study questionnaire. Note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | 1.2g of oral azithromycin |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Participants will be shipped a single 1.2 g dose of oral azithromycin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Symptom Free at Day 14 | Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load - Nasal Swab | Viral load by self-collected nasal swab | 3 days |
| Viral Load - Saliva Swab | Viral load by self-collected saliva swab |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Oldenburg, ScD, MPH | University of California, San Francisco | Principal Investigator |
| Thuy Doan, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34269813 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin | 1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin |
| FG001 | Placebo | Matching placebo Placebos: Participants will be shipped a dose of matching placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 3 |
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| Day 14 |
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| Day 21 |
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A single participant in the Azithromycin group did not have baseline symptom information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin | 1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin |
| BG001 | Placebo | Matching placebo Placebos: Participants will be shipped a dose of matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Were Symptom Free at Day 14 | Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no) | 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. | Posted | Count of Participants | Participants | 14 days |
|
21 days
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin | 1.2g of oral azithromycin Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Lietman, Director of the UCSF FI Proctor Foundation | University of California, San Francisco FI Proctor Foundation | 415-476-1442 | tom.lietman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2021 | Jul 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2020 | Jul 28, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Placebos |
| Drug |
Participants will be shipped a dose of matching placebo |
|
| 3 days |
| Mortality | All-cause mortality | 14 days |
| Adverse Events | Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash | 3 days |
| Positive SARS-CoV-2 Test - Nasal Swab | Prevalence of positive SARS-CoV-2 test by self-collected nasal swab | 3 days |
| Positive SARS-CoV-2 Test - Saliva Swab | Prevalence of positive SARS-CoV-2 test by self-collected saliva swab | 3 days |
| Positive SARS-CoV-2 Test - Rectal Swab | Prevalence of positive SARS-CoV-2 test by self-collected rectal swab | 3 days |
| Genetic Macrolide Resistance Determinants | Prevalence of genetic macrolide resistance determinants by self-collected rectal swab | 3 days |
| Secondary Outcomes Through Day 21 | Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21 | Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days) |
| Number of Participants With Emergency Room Visits | Number of emergency room visits <24 hours | 21 days |
| Number of Household Members With COVID-19 (Confirmed or Symptomatic) | Number of household members with confirmed or symptomatic COVID-19 through Day 21 | 21 days |
| Number of Participants That Died | Deaths within the study | 21 days |
| Number of Participants Reporting Hospitalization | Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment | 21 Days |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 3 participants did not provide their gender information | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Geographic region | Count of Participants | Participants |
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| Alcohol consumption >3x/week | Count of Participants | Participants |
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| Current cigarette smoker | Count of Participants | Participants |
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| Current marijuana user | Count of Participants | Participants |
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| Current e-cigarette/vaping | Count of Participants | Participants |
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| Current cigar use | Count of Participants | Participants |
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| Comorbidities | Count of Participants | Participants |
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| Recent macrolide use (<30 days) | Count of Participants | Participants |
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| Recent hydroxychloroquine use (<7 days) | Count of Participants | Participants |
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| Current medications | Count of Participants | Participants |
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| Current vitamin/supplement use | Count of Participants | Participants |
|
| Self-reported symptoms | Count of Participants | Participants |
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| Number of symptoms | Median | Inter-Quartile Range | Number of symptoms |
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| Duration of symptoms prior to test | Median | Inter-Quartile Range | days |
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| Days between positive test and enrollment | Median | Inter-Quartile Range | days |
|
|
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| Secondary | Viral Load - Nasal Swab | Viral load by self-collected nasal swab | 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 | Posted | 3 days |
|
|
| Secondary | Viral Load - Saliva Swab | Viral load by self-collected saliva swab | 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 | Posted | 3 days |
|
|
| Secondary | Mortality | All-cause mortality | This outcome is based on the 125 participants in the azithromycin group and the 72 participants in the placebo group who completed the trial. | Posted | Count of Participants | Participants | 14 days |
|
|
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| Secondary | Adverse Events | Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash | 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. | Posted | Count of Participants | Participants | 3 days |
|
|
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| Secondary | Positive SARS-CoV-2 Test - Nasal Swab | Prevalence of positive SARS-CoV-2 test by self-collected nasal swab | 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 | Posted | 3 days |
|
|
| Secondary | Positive SARS-CoV-2 Test - Saliva Swab | Prevalence of positive SARS-CoV-2 test by self-collected saliva swab | 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 | Posted | 3 days |
|
|
| Secondary | Positive SARS-CoV-2 Test - Rectal Swab | Prevalence of positive SARS-CoV-2 test by self-collected rectal swab | 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 | Posted | 3 days |
|
|
| Secondary | Genetic Macrolide Resistance Determinants | Prevalence of genetic macrolide resistance determinants by self-collected rectal swab | 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 | Posted | 3 days |
|
|
| Secondary | Secondary Outcomes Through Day 21 | Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21 | Posted | Count of Participants | Participants | Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days) |
|
|
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| Secondary | Number of Participants With Emergency Room Visits | Number of emergency room visits <24 hours | Number of patients who reported emergency room visit information through Day 21 | Posted | Count of Participants | Participants | 21 days |
|
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| Secondary | Number of Household Members With COVID-19 (Confirmed or Symptomatic) | Number of household members with confirmed or symptomatic COVID-19 through Day 21 | Includes the total number of participants from 69 households in the placebo group and 134 households in the azithromycin group | Posted | Count of Participants | Participants | 21 days |
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| Secondary | Number of Participants That Died | Deaths within the study | Participants that completed the day 21 questionnaire were included in this secondary analysis. | Posted | Count of Participants | Participants | 21 days |
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| Secondary | Number of Participants Reporting Hospitalization | Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment | Number of patients who reported hospitalization information through Day 21 | Posted | Count of Participants | Participants | 21 Days |
|
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|
| 0 |
| 145 |
| 0 |
| 145 |
| 132 |
| 145 |
| EG001 | Placebo | Matching placebo Placebos: Participants will be shipped a dose of matching placebo | 0 | 72 | 0 | 72 | 25 | 72 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Other | Gastrointestinal disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Organic Chemicals |
| Abdominal Pain |
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| Vomiting |
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| Rash |
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| Other |
|
| None |
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| Cough |
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| Diarrhea |
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| Abdominal pain |
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| Anosmia |
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| Conjunctivitis |
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| Sore throat |
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| Shortness of breath |
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| Myalgia |
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| Fatigue |
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| Dizziness |
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| Other |
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