Trial · NCT04659109
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression from moderate to severe respiratory distress assessed at Day 4 | Day 4 | Progression from moderate to severe assessed at Day 4 is a composite failure endpoint defined as the occurrence of at least one of the following failure events : * Respiratory rate (RR) ≥ 30/min, or * Oxygen Saturation (SpO2) ≤ 93% in resting state, or * Oxygen Pressure/ Inspired fraction (PaO2/FiO2) ≤ 200mmHg * Death occurring prior to or on Day 4 |
| Secondary | All cause mortality at day 40 | Day 40 (maximum) | |
| Secondary | WHO-COVID-19 Scale | Up to Day 40 | WHO COVID-19 Ordinal Scoring Scale is 9 point ordinal scale |
| Secondary | NEWS-2 Scale | Up to Day 40 | Determines the degree of illness of a patient and prompts critical care intervention (recommended by NHS over original NEWS): total possible score ranges from 0 to 20. The higher the scores the greater the clinical risk. |
| Secondary | Respiratory Rate status (RR) | Up to Day 40 | Respiratory Rate status defined as:: o Normal:\<20/min, * Mild:20/min≤RR\<24/min, * Moderate:24/min≤RR\<30/min, o Severe:≥30/min, * Death. |
| Secondary | Hypoxemia status | Up to Day 40 | Hypoxemia status defined as:: o Normal:\>300mmHg, * Mild: 200 mmHg \< PaO2/FiO2 ≤ 300 mmHg, * Moderate:100mmHg\<PaO2/FIO2≤200mmHg, o Severe:PaO2/FIO2≤100mmHg, * Death. |
| Secondary | SpO2 status | Up to Day 40 | SpO2 status defined as: o Normal:\>95% * Mild:93%\<SpO2≤95%, * Moderate:90%\<SpO2≤93%, o Severe:≤90%, * Death. |
| Secondary | CHEST CT-Scan (or in exceptional cases, chest radiogram) | Day 4 | |
| Secondary | Oxygen-free days | Up to Day 40 | |
| Secondary | Admission to the ICU | Up to Day 40 | |
| Secondary | ICU-free days | Up to Day 40 | |
| Secondary | Hospital-free days | Up to Day 40 | |
| Secondary | Clinical recovery and Time to Clinical recovery | Up to Day 40 | |
| Secondary | Cure and Time-to-cure | Up to Day 40 | |
| Secondary | Incidence, nature and severity of Adverse Events, SAEs, SUSARs and Treatment-Emergent Adverse Events (TEAEs) | Up to Day 40 | |
| Secondary | Incidence of bleeding-related events | Up to Day 40 | |
| Secondary | Incidence of hypersensitivity reactions | Up to Day 40 | |
| Secondary | Changes from baseline on blood pressure | Up to Day 40 | |
| Secondary | Changes from baseline on heart rate | Up to Day 40 | |
| Secondary | Changes from baseline on NFS | Up to Day 40 |
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
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GET https://conductscience.org/api/trials/v1/NCT04659109/registered