NCT04421027 · OUTCOME
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
A Study of Baricitinib (LY3009104) in Participants With COVID-19 · Source last updated 2022-07-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 14
What was measured
Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:
1\. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
Analysis population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
Groups in this outcome
Placebo + SOC
Placebo administered orally QD with standard of care.
Baricitinib + SOC
4 mg baricitinib administered orally QD with standard of care.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + SOC | 756 |
|---|
| Baricitinib + SOC | 762 |
|---|
Reported measurements
Day 14 NIAID-OS 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 51.6 | Not reported | 48.0 | 55.2 | Not reported |
|---|
| Baricitinib + SOC | 56.3 | Not reported | 52.7 | 59.9 | Not reported |
|---|
Day 14 NIAID-OS 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 11.2 | Not reported | 8.9 | 13.5 | Not reported |
|---|
| Baricitinib + SOC | 11.1 | Not reported | 8.8 | 13.4 | Not reported |
|---|
Day 14 NIAID-OS 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 0.3 | Not reported | 0.0 | 0.6 | Not reported |
|---|
| Baricitinib + SOC | 0.1 | Not reported | 0.0 | 0.4 | Not reported |
|---|
Day 14 NIAID-OS 4
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 8.0 | Not reported | 6.0 | 10.0 | Not reported |
|---|
| Baricitinib + SOC | 7.6 | Not reported | 5.7 | 9.6 | Not reported |
|---|
Day 14 NIAID-OS 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 8.4 | Not reported | 6.4 | 10.5 | Not reported |
|---|
| Baricitinib + SOC | 7.3 | Not reported | 5.4 | 9.2 | Not reported |
|---|
Day 14 NIAID-OS 6
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 3.6 | Not reported | 2.2 | 4.9 | Not reported |
|---|
| Baricitinib + SOC | 3.7 | Not reported | 2.3 | 5.1 | Not reported |
|---|
Day 14 NIAID-OS 7
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 9.4 | Not reported | 7.3 | 11.6 | Not reported |
|---|
| Baricitinib + SOC | 8.9 | Not reported | 6.9 | 11.0 | Not reported |
|---|
Day 14 NIAID-OS 8
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 7.5 | Not reported | 5.6 | 9.4 | Not reported |
|---|
| Baricitinib + SOC | 4.9 | Not reported | 3.4 | 6.5 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 1.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.56
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0168
- param Type
- Odds Ratio (OR)
- param Value
- 1.28
- statistical Method
- Proportional Odds Model
Complete source fields
- analyses
- ci Lower Limit
- 1.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.56
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0168
- param Type
- Odds Ratio (OR)
- param Value
- 1.28
- statistical Method
- Proportional Odds Model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 48.0
- upper Limit
- 55.2
- value
- 51.6
- group Id
- OG001
- lower Limit
- 52.7
- upper Limit
- 59.9
- value
- 56.3
- title
- Day 14 NIAID-OS 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.9
- upper Limit
- 13.5
- value
- 11.2
- group Id
- OG001
- lower Limit
- 8.8
- upper Limit
- 13.4
- value
- 11.1
- title
- Day 14 NIAID-OS 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.6
- value
- 0.3
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.4
- value
- 0.1
- title
- Day 14 NIAID-OS 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 10.0
- value
- 8.0
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- 9.6
- value
- 7.6
- title
- Day 14 NIAID-OS 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 10.5
- value
- 8.4
- group Id
- OG001
- lower Limit
- 5.4
- upper Limit
- 9.2
- value
- 7.3
- title
- Day 14 NIAID-OS 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.2
- upper Limit
- 4.9
- value
- 3.6
- group Id
- OG001
- lower Limit
- 2.3
- upper Limit
- 5.1
- value
- 3.7
- title
- Day 14 NIAID-OS 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.3
- upper Limit
- 11.6
- value
- 9.4
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 11.0
- value
- 8.9
- title
- Day 14 NIAID-OS 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 9.4
- value
- 7.5
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 6.5
- value
- 4.9
- title
- Day 14 NIAID-OS 8
- denoms
- counts
- group Id
- OG000
- value
- 756
- group Id
- OG001
- value
- 762
- units
- Participants
- description
- Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:
1\. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Placebo administered orally QD with standard of care.
- id
- OG000
- title
- Placebo + SOC
- description
- 4 mg baricitinib administered orally QD with standard of care.
- id
- OG001
- title
- Baricitinib + SOC
- param Type
- NUMBER
- population Description
- All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
- reporting Status
- POSTED
- time Frame
- Day 14
- title
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice
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