Comparison · NCT05894577-sae
Arm F - Montelukast vs Arm F - Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm F - Montelukast vs Arm F - Placebo: serious adverse events. Trial comparisons, record NCT05894577-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05894577-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00955 | 0.00439 | 0.0207 | wilson | |
| Risk in group 2 | 0.00482 | 0.00164 | 0.0141 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00473 | -0.00587 | 0.0163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.98 | 0.498 | 7.89 | log | |
| Odds ratio, group 1 over group 2 | 1.99 | 0.496 | 7.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm F - Montelukast than on Arm F - Placebo | 211 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm F - Montelukast | Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.~Montelukast: Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use. | 6 | 628 | EG000 |
| Group 2 | Arm F - Placebo | Placebo - appearance and size matched to active study drug.~Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.~Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug. | 3 | 622 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 180 days
Source ClinicalTrials.gov
Trial
- Title
- ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)
- NCT number
- NCT05894577
- Phases
- PHASE3
- Conditions
- Covid19
- Interventions
- Placebo, Montelukast
- Lead sponsor
- Susanna Naggie, MD
- Results first posted
- 2024-08-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05894577?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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