NCT04421027 · OUTCOME
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
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 7
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 7 NIAID-OS 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 20.2 | Not reported | 17.3 | 23.1 | Not reported |
|---|
| Baricitinib + SOC | 25.2 | Not reported | 22.1 | 28.4 | Not reported |
|---|
Day 7 NIAID-OS 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 6.6 | Not reported | 4.8 | 8.4 | Not reported |
|---|
| Baricitinib + SOC | 5.8 | Not reported | 4.1 | 7.5 | Not reported |
|---|
Day 7 NIAID-OS 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 0.5 | Not reported | 0.0 | 1.1 | Not reported |
|---|
| Baricitinib + SOC | 0.2 | Not reported | 0.0 | 0.5 | Not reported |
|---|
Day 7 NIAID-OS 4
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 21.2 | Not reported | 18.2 | 24.1 | Not reported |
|---|
| Baricitinib + SOC | 20.6 | Not reported | 17.6 | 23.5 | Not reported |
|---|
Day 7 NIAID-OS 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 22.5 | Not reported | 19.5 | 25.5 | Not reported |
|---|
| Baricitinib + SOC | 22.5 | Not reported | 19.4 | 25.5 | Not reported |
|---|
Day 7 NIAID-OS 6
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 14.5 | Not reported | 12.0 | 17.0 | Not reported |
|---|
| Baricitinib + SOC | 13.8 | Not reported | 11.3 | 16.2 | Not reported |
|---|
Day 7 NIAID-OS 7
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 11.2 | Not reported | 9.0 | 13.5 | Not reported |
|---|
| Baricitinib + SOC | 10.8 | Not reported | 8.6 | 13.0 | Not reported |
|---|
Day 7 NIAID-OS 8
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | 3.3 | Not reported | 2.0 | 4.5 | Not reported |
|---|
| Baricitinib + SOC | 1.2 | Not reported | 0.4 | 2.0 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0172
- param Type
- Odds Ratio (OR)
- param Value
- 1.25
- statistical Method
- Proportional Odds Model
Complete source fields
- analyses
- ci Lower Limit
- 1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0172
- param Type
- Odds Ratio (OR)
- param Value
- 1.25
- statistical Method
- Proportional Odds Model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.3
- upper Limit
- 23.1
- value
- 20.2
- group Id
- OG001
- lower Limit
- 22.1
- upper Limit
- 28.4
- value
- 25.2
- title
- Day 7 NIAID-OS 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.8
- upper Limit
- 8.4
- value
- 6.6
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 7.5
- value
- 5.8
- title
- Day 7 NIAID-OS 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 1.1
- value
- 0.5
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.5
- value
- 0.2
- title
- Day 7 NIAID-OS 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.2
- upper Limit
- 24.1
- value
- 21.2
- group Id
- OG001
- lower Limit
- 17.6
- upper Limit
- 23.5
- value
- 20.6
- title
- Day 7 NIAID-OS 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.5
- upper Limit
- 25.5
- value
- 22.5
- group Id
- OG001
- lower Limit
- 19.4
- upper Limit
- 25.5
- value
- 22.5
- title
- Day 7 NIAID-OS 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 17.0
- value
- 14.5
- group Id
- OG001
- lower Limit
- 11.3
- upper Limit
- 16.2
- value
- 13.8
- title
- Day 7 NIAID-OS 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.0
- upper Limit
- 13.5
- value
- 11.2
- group Id
- OG001
- lower Limit
- 8.6
- upper Limit
- 13.0
- value
- 10.8
- title
- Day 7 NIAID-OS 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 4.5
- value
- 3.3
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 2.0
- value
- 1.2
- title
- Day 7 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 7
- title
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle