Trial · NCT04475588
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One-month Mortality Rate Between the Two Arms | One-month | 1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30 |
| Primary | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 7, Day 14, Day 21 & Day 30 | Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 \> 92% |
| Primary | Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | Day 30 | Number of patients needing Intubation/IMV post treatment |
| Primary | Reduction in Proportion of Patients on Non-invasive Ventilation | Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30 | Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time |
| Primary | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 7, Day14, Day 21 & Day30 | Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline. Improvement of PaO2: Defined as number of patients with \> 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen). |
| Primary | Reduction in Proportion of Patients- Invasive Mechanical Ventilation | Day7, Day14, Day21 & Day 30 | Patient improved from invasive ventilation over time from baseline. |
| Primary | Reduction in Proportion of Patients-High Flow Nasal Oxygen | Day7 ,Day 14 ,Day 21, Day 30 | Patient improved from High Flow Nasal Oxygen over time from baseline. |
| Primary | Mean Change From Baseline in Ferritin | Day 7, Day 14, Day 21 & Day 30 | Mean Change from Baseline in Ferritin |
| Primary | Mean Change From Baseline in LDH | Day 7, Day14, Day 21 and Day 30. | Mean Change from Baseline in LDH |
| Primary | Mean Change From Baseline in CRP (C-reactive Protein) | Day 7, Day 14, Day 21 & Day 30 | Mean Change from Baseline in CRP |
| Primary | Mean Change From Baseline D-Dimer | Day 7, Day 14, Day 21 & Day 30 | |
| Secondary | Mean Change From Baseline of Absolute Lymphocyte Count | day 7, day 14 ,day 21 & day 30 | Mean change From baseline in Lymphocyte count |
| Secondary | Biomarkers (IL-6, TNF-a) | Pre and Post 1st dose; Pre and Post 2nd dose | Mean values of Pre and Post 1st and 2nd dose are shown |
| Secondary | Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio) | Baseline, Day 7, Day 14, Day 21 & Day 30 | Mean PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) |
| Secondary | Number and Percentage of Patients With Radiological Response | up to Day 30 | Number of patients with improved X ray/CT findings as compared to baseline or returned to normal in the last assessment |
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/NCT04475588/registered