This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Azithromycin for COVID-19 Treatment in Outpatients Nationwide (NCT04332107), a randomized phase 3 study. The primary outcome is Number of Participants Who Were Symptom Free at Day 14.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04332107 |
| Phase | Phase 3 |
| Condition | COVID-19, SARS-CoV-2 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 263 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Thomas M. Lietman |
| Results posted | Yes |
2. Clinical Question
Population
People with a recent positive SARS-CoV-2 test who were not currently hospitalized and had mild or moderate COVID-19. The registry describes the trial as telemedicine-based. It does not report additional eligibility details in the record summarized for this analysis.
Intervention
A single oral dose of azithromycin, described as 1.2g.
Comparator
A matching placebo.
Primary question
What proportion of participants in each randomized treatment group were symptom free at Day 14? The registry also describes an overall assessment and assessments in pre-specified subgroups, but it does not provide the corresponding group results in the available record.
The trial addressed whether assignment to azithromycin rather than matching placebo was associated with the recorded symptom-free status at the stated follow-up. The primary outcome is defined as a yes-or-no assessment of whether a participant was experiencing any symptoms at Day 14. Thus, the question concerns status at a particular time point, rather than time until symptoms improve or the total duration of symptoms.
The registry identifies COVID-19 and SARS-CoV-2 as the conditions under study. The brief summary describes participants with a recent positive test who were not hospitalized, while the official title refers to prevention of disease progression in people with mild or moderate COVID-19. Those descriptions establish the broad clinical setting, but the registry record does not report enough eligibility detail to characterize the enrolled population more narrowly. In particular, no further demographic or clinical profile should be inferred from the trial title or summary.
The treatment contrast is randomized assignment to the azithromycin regimen versus placebo. The registry record does not provide a primary outcome estimate, group-specific symptom-free counts, confidence interval, or analysis test. Therefore, the clinical question can be stated from the design and endpoint, but the available record does not establish the direction, size, or precision of a treatment-group difference.
3. Trial Design
This was a Phase 3, randomized, parallel-group trial with quadruple masking. The registry describes it as an individually randomized, telemedicine-based study of azithromycin in people with mild or moderate COVID-19 who had a recent positive SARS-CoV-2 test and were not currently hospitalized. The intervention was a single oral dose of 1.2g of azithromycin; the comparison group received matching placebo. The enrollment listed in the registry is 263.
The parallel-group structure means participants were assigned to one treatment group and assessed in that group, rather than crossing between azithromycin and placebo. Randomization is intended, in general, to reduce systematic differences between groups at assignment. Masking is intended, in general, to limit the influence of knowledge of assignment on participant experience, care, or outcome assessment. The record labels masking as quadruple, but does not describe which roles were masked or the procedures used to maintain masking.
The registry lists a start date of 2020-05-22 and a primary completion date of 2021-03-16. Its status is terminated. The reason for termination and the timing of that decision are not reported in the registry record. The record does not report the planned allocation ratio, the sequence-generation procedure, concealment procedures, or whether protocol changes occurred.
The primary outcome was the number of participants who were symptom free at Day 14, with the registry describing percentage comparisons by randomized group, overall and in pre-specified subgroups. Secondary outcomes included nasal-swab and saliva viral load, mortality, adverse events, positive SARS-CoV-2 tests from nasal, saliva, and rectal swabs, and genetic macrolide resistance determinants. The registry lists 14 outcome measures, but does not provide analysis results for them in the available record. The registry identifies Thomas M. Lietman as sponsor.
The registry record does not report the planned sample-size justification or the trial's statistical analysis plan. A planning illustration based on an observed effect is not evidence of the trial's original design assumptions, and should not be read as observed power or as a result of the trial.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 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.
Day 3
| Stage | Azithromycin | Placebo |
|---|---|---|
| STARTED | 171 | 92 |
| COMPLETED | 145 | 72 |
| NOT COMPLETED | 26 | 20 |
Reasons for not completing this period:
| Reason | Azithromycin | Placebo |
|---|---|---|
| Lost to Follow-up | 23 | 14 |
| Missing outcome data | 3 | 6 |
Day 14
| Stage | Azithromycin | Placebo |
|---|---|---|
| STARTED | 148 | 78 |
| COMPLETED | 131 | 70 |
| NOT COMPLETED | 17 | 8 |
Reasons for not completing this period:
| Reason | Azithromycin | Placebo |
|---|---|---|
| Lost to Follow-up | 13 | 4 |
| Missing outcome data | 4 | 4 |
Day 21
| Stage | Azithromycin | Placebo |
|---|---|---|
| STARTED | 135 | 74 |
| COMPLETED | 125 | 72 |
| NOT COMPLETED | 10 | 2 |
Reasons for not completing this period:
| Reason | Azithromycin | Placebo |
|---|---|---|
| Lost to Follow-up | 10 | 2 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: A single participant in the Azithromycin group did not have baseline symptom information.
| Characteristic | Unit | Azithromycin | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 171 | 92 | 263 | |
| Age, Continuous | years | 42 (35 to 49) | 44 (35 to 51) | 43 (35 to 50) |
| Sex: Female, Male: Female | Participants | 117 | 57 | 174 |
| Sex: Female, Male: Male | Participants | 51 | 35 | 86 |
| Race/Ethnicity, Customized: Non-Hispanic White | Participants | 94 | 56 | 150 |
| Race/Ethnicity, Customized: Latinx/Hispanic | Participants | 49 | 27 | 76 |
| Race/Ethnicity, Customized: Non-Hispanic Black | Participants | 11 | 1 | 12 |
| Race/Ethnicity, Customized: Non-Hispanic Asian | Participants | 6 | 3 | 9 |
| Race/Ethnicity, Customized: Mixed Race | Participants | 4 | 3 | 7 |
| Race/Ethnicity, Customized: Non-Hispanic Middle Eastern/Arab | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: Prefer not to answer | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Not reported (missing) | Participants | 4 | 0 | 4 |
| Race/Ethnicity, Customized: Non-Hispanic Native American | Participants | 0 | 1 | 1 |
| Geographic region: West | Participants | 79 | 40 | 119 |
| Geographic region: Southeast | Participants | 38 | 14 | 52 |
| Geographic region: Southwest | Participants | 24 | 16 | 40 |
| Geographic region: Midwest | Participants | 21 | 16 | 37 |
| Geographic region: Northeast | Participants | 9 | 6 | 15 |
| Alcohol consumption >3x/week | Participants | 23 | 9 | 32 |
| Current cigarette smoker | Participants | 13 | 5 | 18 |
| Current marijuana user | Participants | 9 | 6 | 15 |
| Current e-cigarette/vaping | Participants | 8 | 2 | 10 |
| Current cigar use | Participants | 1 | 1 | 2 |
| Comorbidities: Asthma | Participants | 21 | 11 | 32 |
| Comorbidities: Hypertension | Participants | 20 | 12 | 32 |
| Comorbidities: Diabetes | Participants | 5 | 5 | 10 |
| Comorbidities: Chronic obstructive pulmonary disease | Participants | 4 | 0 | 4 |
| Comorbidities: Chronic kidney disease | Participants | 1 | 1 | 2 |
| Comorbidities: Cancer | Participants | 1 | 0 | 1 |
| Comorbidities: Stroke | Participants | 1 | 1 | 2 |
| Recent macrolide use (<30 days) | Participants | 22 | 11 | 33 |
| Recent hydroxychloroquine use (<7 days) | Participants | 1 | 0 | 1 |
| Current medications: ACE/ARB inhibitor | Participants | 15 | 14 | 29 |
| Current medications: Metformin | Participants | 4 | 3 | 7 |
| Current medications: Omeprazole | Participants | 1 | 1 | 2 |
| Current medications: Tacrolimus | Participants | 1 | 0 | 1 |
| Current vitamin/supplement use: Vitamin D | Participants | 64 | 37 | 101 |
| Current vitamin/supplement use: Vitamin C | Participants | 61 | 33 | 94 |
| Current vitamin/supplement use: Multivitamin | Participants | 52 | 27 | 79 |
| Current vitamin/supplement use: Zinc | Participants | 49 | 20 | 69 |
| Current vitamin/supplement use: Omega-3 fatty acid | Participants | 14 | 6 | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who Were Symptom Free at Day 14, measured over 14 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is symptom-free status at Day 14. It is a binary outcome: the registry describes whether a participant was experiencing any symptoms at that assessment as yes or no. The endpoint title describes the count of participants who were symptom free, and the stated population comparison is the percentage symptom free in each randomized treatment group, both overall and within pre-specified subgroups.
A fixed-time symptom assessment is useful because it gives a common point at which treatment groups can be compared. In general, a binary endpoint can be communicated as a proportion in each group, together with a measure of the between-group contrast and its uncertainty. Such summaries are interpretable, but they do not by themselves describe when symptoms began or resolved, how severe symptoms were, or how participants felt between assessment times. Those are different questions from symptom status at Day 14.
The registry record does not report group-specific symptom-free counts or percentages, an effect estimate, a confidence interval, or a test result. Consequently, the endpoint definition is available, but the observed primary outcome comparison cannot be interpreted from the posted registry information. One participant in the azithromycin group did not have baseline symptom information; the record does not explain how that information was handled in the primary analysis. Missing baseline symptom information should not be confused with a reported missing Day 14 outcome.
Because the outcome is presented as a count and a percentage-based comparison, it is important to distinguish the number of participants meeting the endpoint from the percentage calculated within a group. The record's primary outcome description does not supply the values needed to make that comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes a randomized comparison and defines the primary endpoint, but does not give the primary outcome results needed to estimate the treatment contrast. It does not report how many participants were symptom free at Day 14 in either group, the percentages by group, a difference or ratio between groups, a confidence interval, or a p-value. The registry record lists 0 analyses. This is a description of the information available in the record, not evidence that the trial collected no outcome data or that no analyses were conducted outside the registry.
Without a group-specific estimate, there is no basis in the registry record for describing whether symptom-free status was more or less frequent under either assignment. Without an uncertainty interval, the precision of any potential difference cannot be assessed. A confidence interval, in general, represents a range of values compatible with the data and the statistical model at a stated confidence level. Its width helps readers judge precision; the interval is not reported for this endpoint.
The primary outcome was intended to be considered overall and in pre-specified subgroups. Subgroup findings, when reported, need careful interpretation because the amount of information within each subgroup is smaller than in the overall comparison, and apparent differences can be uncertain. The registry record does not provide subgroup definitions, group results, or subgroup estimates. No subgroup-specific conclusion can therefore be drawn from this record.
The record does include adverse-event counts. It reports 0 serious adverse events among 145 participants at risk in the azithromycin group and 0 among 72 participants at risk in the placebo group. It also reports other adverse events affecting 132 participants at risk in the azithromycin group and 25 in the placebo group, with 0 deaths in each group. These counts describe the categories as recorded; the record does not provide event descriptions for the other adverse events, an inferential comparison, or an explanation of the category definitions. The absence of reported serious events in these counts is not the same as proof that a treatment has no serious risks.
The terminated status is relevant context for readers assessing completeness, but the registry record does not state why the trial was terminated or whether termination affected follow-up or analysis. It would be inappropriate to infer a reason from the status alone. The listed secondary outcomes likewise do not establish findings: their names identify what was assessed, not the observed results.
Overall, the posted information supports a description of the randomized design, the intended Day 14 symptom endpoint, and the adverse-event counts. It does not support a quantitative estimate of the primary treatment effect, a claim about its statistical significance, or a conclusion about the clinical importance of any difference. The principal interpretive limitation is therefore not a particular estimated effect with wide or narrow uncertainty, but the absence of a reported primary comparison in the registry record.
9. Statistical Methods Explained
Statistical methods help translate observed outcomes into estimates while making the assumptions and uncertainty visible. The registry record gives important design labels and the endpoint definition, but it does not report the analysis details needed to reproduce or evaluate the primary comparison. The explanations below are general statistical context, not claims about methods used in this trial.
What does randomization contribute?
In general, random assignment is used to make treatment groups comparable in expectation with respect to measured and unmeasured characteristics at the point of assignment. It does not guarantee that groups will be identical in a particular trial. A sound analysis also needs to specify which randomized participants are included, how outcomes are handled when unavailable, and whether the comparison follows assigned treatment. The registry labels this study randomized, but does not report the primary analysis population or the analysis rule for deviations from assigned treatment.
How can a binary endpoint be compared?
For an endpoint recorded as yes or no, an analysis may begin with the number meeting the endpoint and the number assessed in each group. The proportion meeting the endpoint can then be compared across groups using a measure such as a difference in proportions or a relative measure. These quantities answer different questions, so an estimate needs to be clearly defined. The registry describes a percentage comparison for symptom-free status, but does not report the counts, percentages, selected effect measure, or its estimated value.
A confidence interval accompanies an estimate by conveying statistical uncertainty under the analysis assumptions. In general, a narrower interval indicates greater precision than a wider interval, while an interval that includes values representing no difference may be consistent with several underlying effects. An interval does not indicate the probability that a particular treatment effect is true, and it cannot remedy limitations in how outcomes were collected or analyzed. No confidence interval for the primary outcome is reported in the registry record.
A hypothesis test may summarize how compatible the observed data are with a specified null model. A p-value is not the probability that the null hypothesis is true, nor does it describe the size or importance of an effect. Interpretation should consider the estimate and its interval, not a threshold alone. The registry record does not report a primary-outcome test statistic or p-value.
Why does the analysis population matter?
In general, an analysis of participants according to randomized assignment preserves the comparison created by randomization, provided the analysis and outcome handling are appropriate. Other analysis populations can answer different questions and may be more vulnerable to selection effects. The record does not state whether the primary analysis was intention-to-treat, per-protocol, or based on another population. It also does not define how participants with missing outcomes, protocol deviations, or unavailable follow-up were treated.
The registry notes that a single participant in the azithromycin group lacked baseline symptom information. Baseline data can be used to describe participants or adjust an analysis, but the record does not say whether this information entered the primary model or affected endpoint eligibility. It also does not report the amount of missing Day 14 outcome data. The baseline note alone cannot be used to infer how complete follow-up was.
What is the role of the design labels?
The parallel model indicates separate randomized groups. Quadruple masking indicates that the registry records masking at that level, but the roles covered and the practical procedures are not described. In general, masking can reduce the risk that expectations influence symptom reporting or assessment. It does not remove other sources of bias, such as missing outcomes or deviations from a prespecified analysis. Randomization and masking are features of the design, not substitutes for reporting the analysis and results.
The trial was listed as Phase 3 and terminated. Neither label gives the primary result. Termination may arise for different reasons, and the registry record does not specify the reason, whether enrollment stopped before a planned target, or whether the decision was related to emerging outcome data. No explanation should be inferred without a registry report of the circumstances.
How should planning calculations be read?
The sample-size assumptions describe a planning illustration computed from the observed effect, using a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. The illustration considers an effect to detect expressed as a fraction of the observed effect. These assumptions describe the calculation, not necessarily the trial's protocol or original design. The registry record does not report the trial's own sample-size justification.
Sample-size calculations are planning tools: they describe how much information a hypothetical design might need under specified assumptions. They are not a measure of the probability that this completed trial detected a real effect. In particular, a planning calculation based on an observed effect is not observed power. No calculated planning values are repeated here, and they should not be mistaken for participants enrolled, analyzed, or observed in the trial.
For count outcomes, variation can exceed what a simple model assumes; in general, over-dispersion means the observed variability is greater than the model's expected variability. Accounting for it can affect standard errors and confidence intervals. The primary endpoint in this record is binary, and the registry does not report a model or an over-dispersion adjustment for it. Such methods should not be attributed to this trial in the absence of a reported analysis plan or results.
What is not reported?
The registry record does not report the primary model, covariates, effect measure, confidence interval method, test, handling of missing outcomes, subgroup analysis method, or statistical analysis plan. It also does not provide results for the listed secondary outcomes. These omissions prevent a detailed assessment of whether the analysis matched a prespecified plan, how uncertainty was calculated, and how robust the findings might be to alternate reasonable choices. General statistical concepts can clarify what such information would mean, but cannot fill in the unreported methods.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes an overall comparison and pre-specified subgroup assessments, while the registry lists 14 outcome measures and multiple secondary outcome topics. Considering multiple endpoints or subgroups raises a multiplicity issue: the more comparisons examined, the greater the opportunity for some results to appear notable by chance. In general, an analysis plan can address this by identifying a primary comparison, specifying which other analyses are confirmatory or exploratory, and describing any adjustment or interpretation strategy.
The registry record does not report a multiplicity adjustment, a hierarchy among the outcomes, or the inferential status of subgroup analyses. It also does not give subgroup definitions or results. No claim about adjustment or control of false-positive findings can therefore be made. The listed outcome measures identify intended assessments, but do not tell readers how many were analyzed or how their results were interpreted.
Missing-data interpretation is also limited. The registry notes that a single participant in the azithromycin group did not have baseline symptom information. That statement concerns baseline information; it does not establish whether the Day 14 endpoint was missing for that participant or anyone else. The registry record does not report missing-outcome counts, reasons for missingness, imputation methods, sensitivity analyses, or follow-up completeness.
The record does not identify the primary analysis population or state how participants were handled if they did not complete follow-up or did not adhere to assigned treatment. In general, decisions about analysis populations and missing data can affect estimates and uncertainty. Those decisions should be reported rather than inferred from randomization or from enrollment. Without the analysis rules and outcome availability, readers cannot determine how missing data or multiplicity influenced the primary comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Azithromycin | 0 | 145 | 0.0% |
| Placebo | 0 | 72 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Azithromycin | 0 of 145 |
| Placebo | 0 of 72 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Azithromycin | 132 of 145 |
| Placebo | 25 of 72 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Azithromycin | Placebo |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 60 of 145 | 12 of 72 |
| Nausea | Gastrointestinal disorders | 32 of 145 | 7 of 72 |
| Abdominal pain | Gastrointestinal disorders | 25 of 145 | 1 of 72 |
| Other | Gastrointestinal disorders | 10 of 145 | 3 of 72 |
| Vomiting | Gastrointestinal disorders | 5 of 145 | 2 of 72 |
The registry reports serious adverse events in separate group summaries. For azithromycin, 0 serious adverse events are reported among 145 participants at risk; for placebo, 0 are reported among 72 participants at risk. The registry also reports 0 deaths in each group. No top serious adverse-event terms are listed.
For the category labeled other adverse events, the record reports 132 affected among 145 at risk in the azithromycin group and 25 affected among 72 at risk in the placebo group. These are counts, not adjusted comparisons. The registry record does not define the other-event category in enough detail to explain which events were included, and it does not provide event-level descriptions or a statistical comparison for these counts.
Zero reported serious events in these summaries means that none are recorded in those group counts; it does not establish that serious events are impossible or that the groups have identical safety profiles. Safety interpretation depends on what was collected, the follow-up period, event definitions, and completeness of reporting. The registry record does not provide enough information on those points to characterize the safety evidence beyond the posted counts. Counts should not be converted into a treatment conclusion without the missing context and an appropriate analysis.
12. What the Result Does, and Does Not, Mean
The registry record documents a Phase 3 randomized comparison of a single 1.2g oral dose of azithromycin with matching placebo in an outpatient COVID-19 trial. It specifies symptom-free status at Day 14 as the primary outcome and lists a range of secondary assessments. It also provides group-level adverse-event counts and identifies the study as terminated. These details describe the design and the content of the recorded outcomes.
They do not, however, answer whether the primary endpoint differed between randomized groups. The registry record does not report the symptom-free counts or percentages, an estimated effect, an uncertainty interval, or a test result. Consequently, it cannot support a claim about the direction or magnitude of a primary outcome difference, its precision, or its statistical significance. Nor do the listed secondary outcomes indicate what their results were.
In general, a statistically uncertain estimate is not the same as evidence of no difference, and a statistically notable estimate is not automatically clinically important. Both judgments require the estimate, its uncertainty, the endpoint context, and the analysis details. In this record, those primary comparison results are not reported, so neither a positive nor a null conclusion is justified from the available registry information.
The safety counts are also limited in what they establish. They record 0 serious adverse events in each group and the reported counts for other adverse events, but do not provide the event descriptions or enough methodological context to assess comparative risk. A count of zero is not proof of absence of risk, and differing counts alone do not establish a causal effect.
The trial's terminated status does not explain its outcome or the reason it stopped. Without that information, it should be treated as a record-status detail rather than evidence for or against a treatment effect. The appropriate conclusion is narrow: the registry describes a randomized trial and its intended outcomes, but the primary efficacy comparison and its precision are not reported in the available registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between design information and result information. Randomization, masking, a defined primary endpoint, and a parallel-group structure describe how the comparison was intended to be organized. They do not substitute for reporting group outcomes, an effect estimate, and uncertainty. Readers need both the design and the results to evaluate a clinical comparison.
The endpoint is a binary symptom assessment at a fixed time, stated as Day 14. Such an outcome can be accessible to clinical readers, but interpretation depends on a clear denominator, a definition of symptom status, and transparent handling of missing assessments. The registry provides the outcome description and notes missing baseline symptom information for a participant in the azithromycin group, but does not provide the primary group results or the analysis handling.
The record also illustrates why status labels need context. Terminated is a meaningful registry status, but the reason and consequences are not reported. Statistical interpretation should not turn a status label into a conclusion about efficacy, safety, or the conduct of the trial. Likewise, a list of secondary outcomes is not equivalent to results for those outcomes.
Finally, planning calculations and observed trial findings serve different purposes. A planning illustration based on an observed effect can help explore hypothetical design requirements under stated assumptions, but it is not observed power and is not the original sample-size justification unless the registry says so. Keeping those categories separate avoids treating a design calculation as evidence about a treatment. The central statistical lesson is that transparent estimates, uncertainty, analysis populations, and missing-data methods are essential to interpret a randomized trial.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation for interpretation is that the registry record does not report the primary outcome comparison. There are no group-specific Day 14 symptom-free counts or percentages, no effect estimate, no confidence interval, and no test result. The record lists 0 analyses, so the available registry information cannot establish the size or precision of the planned primary comparison.
The registry states that the primary outcome was to be assessed overall and in pre-specified subgroups, but it does not report subgroup definitions or results. It lists 14 outcome measures and names secondary outcomes, but does not provide their findings or explain how multiple comparisons were handled. These gaps preclude an assessment of subgroup evidence, secondary outcome patterns, or multiplicity control.
The record notes that a single participant in the azithromycin group lacked baseline symptom information, but does not report the amount or handling of missing primary outcome data. It does not identify the analysis population, statistical model, treatment of protocol deviations, or sensitivity analyses. The degree to which these choices could affect the endpoint estimate is therefore unknown.
The trial is marked terminated, but the reason, timing, and implications for follow-up are not reported. The record also does not describe the masking roles or procedures, allocation ratio, or sample-size justification. These details should not be reconstructed from the study status or from the planning illustration.
Safety reporting is limited to event counts. The registry does not supply the detailed definitions and descriptions needed to interpret the category of other adverse events, and no comparative safety analysis is reported. Together, these limits mean the registry supports a description of the trial design and selected counts, but not a complete appraisal of efficacy, uncertainty, missing data, or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Azithromycin for COVID-19 Treatment in Outpatients Nationwide — NCT04332107.
- Registry record last updated 2023-03-02; status last verified 2023-02.
- Results first posted 2021-09-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry describes NCT04332107, Azithromycin for COVID-19 Treatment in Outpatients Nationwide, as a Phase 3 randomized, quadruple-masked, parallel-group trial. The study compared a single oral dose of 1.2g of azithromycin with matching placebo in people with mild or moderate COVID-19 who had a recent positive SARS-CoV-2 test and were not currently hospitalized. Enrollment was 263. The listed start date is 2020-05-22, primary completion date is 2021-03-16, and status is terminated.
The primary outcome was symptom-free status at Day 14, described as a yes-or-no symptom assessment and a percentage comparison by group. The registry also lists viral-load, mortality, adverse-event, positive-test, and resistance outcomes. It reports adverse-event counts, including 0 serious events in each group, but does not report the primary group results, effect estimate, confidence interval, or test. The reason for termination, analysis populations, missing-outcome handling, and detailed statistical plan are not reported in the registry record.