COVID-19Phase 3ACTIONNCT04332107
Azithromycin for COVID-19 Treatment in Outpatients Nationwide
A Phase 3 study testing Azithromycin in people with COVID-19 and SARS-CoV-2, run by Thomas M. Lietman at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 30 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
- Not currently hospitalized
- Willing and able to receive study drug by mail
- Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
- No known allergy or other contraindication to macrolides
- Age 18 years or older at the time of enrollment
Show all 11Show fewer
- No known history of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
- No recent use of hydroxychloroquine within the past 7 days for participants >55 years of age
- Not currently taking nelfinavir or warfarin (Coumadin)
- Provision of informed consent
- Not currently pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
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.
Read the detailed description
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.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Azithromycin, Placebos
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Participants will be shipped a single 1.2 g dose of oral azithromycin
PlacebosDrug
Participants will be shipped a dose of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | 1.2g of oral azithromycin Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days
Secondary outcomes (13)
Viral Load - Nasal Swab
Viral load by self-collected nasal swab
Measured: 3 days
Viral Load - Saliva Swab
Viral load by self-collected saliva swab
Measured: 3 days
Mortality
All-cause mortality
Measured: 14 days
Adverse Events
Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash
Measured: 3 days
Positive SARS-CoV-2 Test - Nasal Swab
Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Measured: 3 days
Positive SARS-CoV-2 Test - Saliva Swab
Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Measured: 3 days
Positive SARS-CoV-2 Test - Rectal Swab
Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Measured: 3 days
Genetic Macrolide Resistance Determinants
Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Measured: 3 days
Secondary Outcomes Through Day 21
Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21
Measured: 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
Measured: 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
Measured: 21 days
Number of Participants That Died
Deaths within the study
Measured: 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
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start22 May 2020
- Primary completion16 Mar 2021
- Study completion30 Mar 2021
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas M. Lietman
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Pfizer, Stanford University
- Responsible party
- Sponsor-investigator, Thomas M. Lietman, University of California, San Francisco
- Investigators
- Catherine Oldenburg, ScD, MPH, Principal investigator, University of California, San FranciscoThuy Doan, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332107
- Sponsor's protocol ID
- 20-30504
- Acronym
- ACTION
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2020
- Last updated
- 2 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34269813
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04332107
- Acronym / sponsor ID
- ACTION / 20-30504
- Conditions
- COVID-19, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Thomas M. LietmanUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Pfizer, Stanford University
- Study start
- 22 May 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Azithromycin1.2g of oral azithromycin |
| Placebo | Placebo comparator | Drug: PlacebosMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
- Not currently hospitalized
- Willing and able to receive study drug by mail
- Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
- No known allergy or other contraindication to macrolides
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinParticipants will be shipped a single 1.2 g dose of oral azithromycin | Drug | Azithromycin |
| PlacebosParticipants will be shipped a dose of matching placebo | Drug | Placebo |
Primary outcome
Number of Participants Who Were Symptom Free at Day 14
Time frame: 14 days
Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
13 secondary outcomes
Viral Load - Nasal Swab
Time frame: 3 days
Viral Load - Saliva Swab
Time frame: 3 days
Mortality
Time frame: 14 days
Adverse Events
Time frame: 3 days
Positive SARS-CoV-2 Test - Nasal Swab
Time frame: 3 days
Positive SARS-CoV-2 Test - Saliva Swab
Time frame: 3 days
Positive SARS-CoV-2 Test - Rectal Swab
Time frame: 3 days
Genetic Macrolide Resistance Determinants
Time frame: 3 days
Secondary Outcomes Through Day 21
Time frame: Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days)
Number of Participants With Emergency Room Visits
Time frame: 21 days
Number of Household Members With COVID-19 (Confirmed or Symptomatic)
Time frame: 21 days
Number of Participants That Died
Time frame: 21 days
Number of Participants Reporting Hospitalization
Time frame: 21 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34269813Oldenburg 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Oldenburg, ScD, MPH principal investigator
University of California, San Francisco
Thuy Doan, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with COVID-19 and SARS-CoV-2, run by Thomas M. Lietman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Were Symptom Free at Day 14 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.