Trial Outcomes & Findings for Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection (NCT NCT04371471)
NCT ID: NCT04371471
Last Updated: 2022-07-19
Results Overview
Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The STC-19 score is based on the genito-thyroid index (GTi) calculated from the neutrophil-to-lymphocyte ratio (NLR) and the cortisol index : Normal value for cortisol range from 3 to 7 Normal value for GTi range from 1.5 to 2.5
COMPLETED
91 participants
Day 0
2022-07-19
Participant Flow
Participant milestones
| Measure |
Patient With Covid-19
Patient with clinical signs of CoV-2-SARS infection and signs of severity
STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
|
|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patient With Covid-19
n=91 Participants
Patient with clinical signs of CoV-2-SARS infection and signs of severity
STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=91 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=91 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=91 Participants
|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 16.4 • n=91 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=91 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=91 Participants
|
|
Region of Enrollment
France
|
91 participants
n=91 Participants
|
|
Body mass index
|
27.2 kg/m^2
STANDARD_DEVIATION 5.4 • n=91 Participants
|
|
Hypertension
|
54 Participants
n=91 Participants
|
|
Diabetes
|
67 Participants
n=91 Participants
|
|
Chronic respiratory disease
|
71 Participants
n=91 Participants
|
PRIMARY outcome
Timeframe: Day 0Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The STC-19 score is based on the genito-thyroid index (GTi) calculated from the neutrophil-to-lymphocyte ratio (NLR) and the cortisol index : Normal value for cortisol range from 3 to 7 Normal value for GTi range from 1.5 to 2.5
Outcome measures
| Measure |
Alive Within 29 Days of Hospitalization
n=56 Participants
Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.
Still living at day 29 after hospitalization
|
Death Within 29 Days of Hospitalization
n=25 Participants
Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.
Death due to coronavirus disease (COVID-19) was defined as death prior to day 29.
Any deaths from day 29 days onward were considered as death from complications of COVID-19.
|
|---|---|---|
|
Number of Participants With Normal and Above Triage (STC-19) Score
Cortisol index adjusted · Normal value
|
55 Participants
|
0 Participants
|
|
Number of Participants With Normal and Above Triage (STC-19) Score
Cortisol index adjusted · Above normal value
|
0 Participants
|
21 Participants
|
|
Number of Participants With Normal and Above Triage (STC-19) Score
Genito-thyroid index · Normal value
|
52 Participants
|
12 Participants
|
|
Number of Participants With Normal and Above Triage (STC-19) Score
Genito-thyroid index · Above normal value
|
4 Participants
|
5 Participants
|
|
Number of Participants With Normal and Above Triage (STC-19) Score
Genito-thyroid index · Missing data
|
0 Participants
|
8 Participants
|
|
Number of Participants With Normal and Above Triage (STC-19) Score
Cortisol index adjusted · Missing data
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 5Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The genito-thyroid index (GTi) is calculated from the neutrophil-to-lymphocyte ratio (NLR). Normal value for GTi range from 1.5 to 2.5
Outcome measures
| Measure |
Alive Within 29 Days of Hospitalization
n=56 Participants
Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.
Still living at day 29 after hospitalization
|
Death Within 29 Days of Hospitalization
n=25 Participants
Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2.
Death due to coronavirus disease (COVID-19) was defined as death prior to day 29.
Any deaths from day 29 days onward were considered as death from complications of COVID-19.
|
|---|---|---|
|
Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
Normal value
|
33 Participants
|
4 Participants
|
|
Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
Above normal value
|
11 Participants
|
10 Participants
|
|
Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
Missing data
|
12 Participants
|
11 Participants
|
Adverse Events
Patient With Covid-19
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place