Trial · NCT04412291
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to recovery | Day 1 through Day 29 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale:1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 1; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. 1 LMWH-injections (Fragmin, Innohep) do not count as medical care |
| Secondary | Mortality | Up to day 29 | |
| Secondary | Number of Days on mechanical ventilation | Up to day 29 | |
| Secondary | Number of days of supplemental oxygen use | Up to day 29 | |
| Secondary | Number of patients requiring initiation of mechanical ventilation | Up to day 29 | |
| Secondary | Time to improvement in oxygenation for at least 48 hours | Up to day 29 | Definition of improvement in oxygenation: Increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 |
| Secondary | Mean change in the 8-point ordinal scale | Up to day 15 | 8-point Ordinal Scale: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow nasal cannula; 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized |
| Secondary | Proportion of patients on level e-h on the 8-point ordinal scale at day 15 | Day 15 | 8-point Ordinal Scale: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow nasal cannula; 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized |
| Secondary | Time to improvement in one category from baseline using the 8-point ordinal scale | Up to day 29 | 8-point Ordinal Scale: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow nasal cannula; 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized |
| Secondary | Mean change in Sequential organ failure assessment score (SOFA) | Up to day 15 | |
| Secondary | Time to resolution of fever for at least 48 hours by clinical severity | Up to day 29 | Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic) |
| Secondary | Time to improvement of three points from baseline in National Early Warning Score 2 (NEWS2) scoring system | Up to day 29 | NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C) |
| Secondary | Time to score of <2 maintained for 24 hours in NEWS2 scoring system (National Early Warning Score) | Up to day 29 | NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C) |
| Secondary | Mean change in NEWS2 scoring system (National Early Warning Score) | Up to day 15 | |
| Secondary | Number of days with fever. | Up to day 29 | Based on highest measured daily body temperature. Defined as \>36.6°C (axilla), \>37.2°C (oral) or \>37.8°C (rectal or tympanic |
| Secondary | Number of days of resting respiratory rate >24 breaths/min | Up to day 29 | Based on highest respiratory rate measured between 06.00 and 09.00 each day |
| Secondary | Time to saturation ≥94% on room air | Up to day 29 | |
| Secondary | Cumulative dose of steroids; equivalent to betamethasone dosage (mg) | From start of steroid treatment for Covid-19 up to day 29 | |
| Secondary | Cumulative dose of steroids during the study; equivalent to betamethasone dosage (mg) | From day 1 up to day 29 | |
| Secondary | Incidence of serious adverse events | Up to day 60 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04412291/registered