| Primary | Time to Sustained Recovery in 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. | Participants with data collected. | Posted | | Median | 95% Confidence Interval | days | | Up to 28 days | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00010(10 to 11)
- OG00110(10 to 11)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Hazard Ratio (HR) | 1.02 | | | 2-Sided | 95 | 0.92 | 1.12 | | | The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity. | | Superiority | Posterior probability of efficacy (P(HR>1)) | |
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| Secondary | Number of Participants With Hospitalization or Death | | | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Mortality | | | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Time to Mortality | Time to mortality was the number of days between drug receipt and death. | Data not collected as no participants experienced mortality. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | | | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants at Each Score on the COVID Clinical Progression Scale at 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. | Participants with data collected at day 7. | Posted | | Count of Participants | | Participants | | Day 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants at Each Score on the COVID Clinical Progression Scale at 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. | Participants with data collected at day 14. | Posted | | Count of Participants | | Participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants at Each Score on the COVID Clinical Progression Scale at 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. | Participants with data collected at day 28. | Posted | | Count of Participants | | Participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function | 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. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, 120, and 180 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue | 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. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, 120, and 180 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Pain | 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 pain. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, 120, and 180 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Depression | The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domain 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 depression. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, 120, and 180 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety | 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 anxiety. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, 120, and 180 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Social | 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 social roles and activities. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, 120, and 180 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep | 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 sleep. | Participants with data collected at each timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 7, 14, 28, 90, and 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Time Unwell in Days as Measured by the Symptom and Clinical Event Scale | The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors. | Participants with data collected. | Posted | | Mean | 95% Confidence Interval | days | | Up to 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Mean Days Benefit as Measured by the Symptom and Clinical Event Scale | The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval. | Participants with data collected. | Posted | | Mean | 95% Confidence Interval | days | | Up to 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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