Trial · NCT05894577
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)
NCT05894577, Phase 3, Completed, Susanna Naggie, MD; results first posted 2024-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast). Trials, record NCT05894577. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05894577
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)
- NCT number
- NCT05894577
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,453 participants, actual
- Lead sponsor
- Susanna Naggie, MD
- Conditions
- Covid19
- Interventions
- Placebo, Montelukast
- First posted
- 2023-06-08
- Last updated
- 2025-01-17
- Results first posted
- 2024-08-16
- Limitations and caveats
The first 202 participants to enroll to the montelukast study arm enrolled under protocol version 6, which only included follow-up through 120 days. The remainder of those enrolled to this study arm were consented to participate in the study up to 180 days. Of the 202 participants who enrolled under protocol version 6, two participants responded to Day 180 survey questions. Those participants are included in the Day 180 analysis to utilize all available responses.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Sustained Recovery in Days | Up to 28 days | Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time. |
| Secondary | Number of Participants With Hospitalization or Death | Up to 28 days | |
| Secondary | Number of Participants With Mortality | Up to 28 days | |
| Secondary | Time to Mortality | Up to 28 days | Time to mortality was the number of days between drug receipt and death. |
| Secondary | Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | Up to 28 days | |
| Secondary | Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7 | Day 7 | COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death. |
| Secondary | Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14 | Day 14 | COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death. |
| Secondary | Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28 | Day 28 | COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death. |
| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function | Day 7, 14, 28, 90, 120, and 180 | The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function. |
| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue | Day 7, 14, 28, 90, 120, and 180 | The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Sustained Recovery in Days | Up to 28 days | Participants with data collected. | days | MEDIAN |
| SECONDARY | Number of Participants With Hospitalization or Death | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Mortality | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Mortality | Up to 28 days | Data not collected as no participants experienced mortality. | ||
| SECONDARY | Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7 | Day 7 | Participants with data collected at day 7. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14 | Day 14 | Participants with data collected at day 14. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28 | Day 28 | Participants with data collected at day 28. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function | Day 7, 14, 28, 90, 120, and 180 | Participants with data collected at each timepoint. | score on a scale | MEDIAN |
| SECONDARY | Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue | Day 7, 14, 28, 90, 120, and 180 | Participants with data collected at each timepoint. | score on a scale | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Sustained Recovery in Days | Arm F - Montelukast | 10 | 95% Confidence Interval 10 to 11 | days | |
| Time to Sustained Recovery in Days | Arm F - Placebo | 10 | 95% Confidence Interval 10 to 11 | days | |
| Number of Participants With Hospitalization or Death | Arm F - Montelukast | 2 | Participants | ||
| Number of Participants With Hospitalization or Death | Arm F - Placebo | 2 | Participants | ||
| Number of Participants With Mortality | Arm F - Montelukast | 0 | Participants | ||
| Number of Participants With Mortality | Arm F - Placebo | 0 | Participants | ||
| Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | Arm F - Montelukast | 18 | Participants | ||
| Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | Arm F - Placebo | 18 | Participants | ||
| Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7 | Arm F - Montelukast | 0 = No clinical or virological evidence of infection | 22 | Participants | |
| Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7 | Arm F - Placebo | 0 = No clinical or virological evidence of infection | 28 | Participants |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm F - Montelukast | 741 | |
| Overall Study | STARTED | Arm F - Placebo | 712 | |
| Overall Study | COMPLETED | Arm F - Montelukast | 628 | |
| Overall Study | COMPLETED | Arm F - Placebo | 622 | |
| Overall Study | NOT COMPLETED | Arm F - Montelukast | 113 | |
| Overall Study | NOT COMPLETED | Arm F - Placebo | 90 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | Arm F - Montelukast | 1 | 628 | |
| serious | Pneumonia | Infections and infestations | Arm F - Placebo | 1 | 622 | |
| serious | Acute appendicitis | Gastrointestinal disorders | Arm F - Montelukast | 0 | 628 | |
| serious | Acute appendicitis | Gastrointestinal disorders | Arm F - Placebo | 1 | 622 | |
| serious | Cellulitis of legs | Skin and subcutaneous tissue disorders | Arm F - Montelukast | 1 | 628 | |
| serious | Cellulitis of legs | Skin and subcutaneous tissue disorders | Arm F - Placebo | 0 | 622 | |
| serious | Torsion of ovary | Reproductive system and breast disorders | Arm F - Montelukast | 1 | 628 | |
| serious | Torsion of ovary | Reproductive system and breast disorders | Arm F - Placebo | 0 | 622 | |
| serious | Atrial fibrillation with rapid ventricular response | Cardiac disorders | Arm F - Montelukast | 1 | 628 | |
| serious | Atrial fibrillation with rapid ventricular response | Cardiac disorders | Arm F - Placebo | 0 | 622 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm F - Montelukast | 0 | 628 |
| Total, all-cause mortality | Arm F - Placebo | 0 | 622 |
| Total, other adverse events | Arm F - Montelukast | 0 | 628 |
| Total, other adverse events | Arm F - Placebo | 0 | 622 |
| Total, serious adverse events | Arm F - Montelukast | 6 | 628 |
| Total, serious adverse events | Arm F - Placebo | 3 | 622 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U24TR001608 | Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT) | BENJAMIN, DANIEL K. | DUKE UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2016 to 2022 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm F - Montelukast vs Arm F - Placebo: Number of Participants With Mortality | Trial comparisons |
| Arm F - Montelukast vs Arm F - Placebo: Number of Participants With Hospitalization or Death | Trial comparisons |
| Arm F - Montelukast vs Arm F - Placebo: Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | Trial comparisons |
| Arm F - Montelukast vs Arm F - Placebo: deaths from any cause | Trial comparisons |
| Arm F - Montelukast vs Arm F - Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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