Trial · NCT04366739
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time To Response (TTR) | 28 days | The primary endpoint is the time to response (TTR) in days, from randomization to 28th day. By response to treatment is meant the reduction of at least one severity level on the World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI) The WHO-OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19. This scale was established by the WHO, which recommends its use for any therapeutic study on COVID-19. This will be a continuous outcome defined by the amount of time between randomization to the first response. This will be treated as a time-to-event with possible censoring. |
| Secondary | Objective Response Rate (ORR) | 28 days from randomization | Response rate regarding the World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI). This will be a binary outcome defined by clinical conditions improvement assessment from randomization to 28th Day, by the response to treatment is meant the reduction of at least one severity level on the World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI). |
| Secondary | All-cause mortality | 28 days after randomization | All-cause mortality rates at Day 28th after randomization |
| Secondary | Duration in days required for hospital discharge | 28 days after randomization | This will be a continuous outcome defined by the amount of time in days between randomization and the hospital discharge |
| Secondary | Duration in days required for National Early Warning Score ≤ 2 maintained 24 hours | 28 days after randomization | This will be a continuous outcome defined by the amount of time in days between randomization and National Early Warning Score ≤ 2 maintained for almost 24 hours The National Early Warning Score (NEWS) is a score used in the ICU to evaluate the overall severity of the clinical condition of a patient. |
| Secondary | Number of days without oxygen therapy | 28 days after randomization | This will be a continuous outcome defined by the amount of time in days without oxygen therapy |
| Secondary | Incidence of oxygen use, NIV or high flow oxygen therapy | 28 days after randomization | Number of clinical conditions that need a prescription for Oxygen therapy, NIV or high flow oxygen therapy |
| Secondary | Duration in days of oxygen prescription, NIV or high flow oxygen therapy | 28 days after randomization | This will be a continuous outcome defined by the amount of time in days with oxygen therapy, NIV, or high flow oxygen therapy. |
| Secondary | Biochemical response: rate of patients positive for SARS-CoV-2 PCR on a nasopharyngeal sample | day 7 from randomization | Rate of patients positive for SARS-CoV-2 PCR on a nasopharyngeal sample (biobank sample) (day 7) This will be a binary outcome defined by positive or negative results at SARS-CoV-2 PCR on a nasopharyngeal sample |
| Secondary | Biochemical response: viral load of SARS-CoV-2 on a nasopharyngeal sample | day 7 from randomization | This will be a quantitative variable. Biobank sample at day 7 |
| Secondary | Biochemical response: serum viral load of SARS-CoV-2 | day: 3,5,7,14,21,28 | This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 |
| Secondary | Biochemical response: C-reactive protein (CRP) | day: 3,5,7,14,21,28 | This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 |
| Secondary | Biochemical response: blood test for lymphocytes (lymphopenia) | day: 3,5,7,14,21,28 | This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 |
| Secondary | Parenchymal involvement (chest CT) | day 7 | Extension score of parenchymal involvement in thoracic computed tomography (CT) (D7) |
| Secondary | Define the optimal dose of CPZ and its tolerance: rates of serious adverse events | 28 days | Rates of serious adverse events |
| Secondary | Define the optimal dose of CPZ and its tolerance: rates of non-serious side effects | 28 days | Rates of non-serious side effects |
| Secondary | Define the optimal dose of CPZ and its tolerance: anxiety assessment on Global Anxiety - Visual Analog Scale (GA-VAS) | 28 days | Global Anxiety - Visual Analog Scale (GA-VAS) is a scale for the assessment of anxiety. The 100 mm GA-VAS varies from minimum (not at all anxious) to maximum (Extremely anxious). This will be a quantitative variable, the distance from the left edge of the line to the mark placed by the patient is measured to the nearest millimeter and used in analyses as the patient's GA-VAS score. |
| Secondary | Define the optimal dose of CPZ and its tolerance: Rates of drug discontinuation | 28 days | Rates of drug discontinuation in all causes under study |
| Secondary | Define the optimal dose of CPZ and its tolerance: biological anomalies | day: 3,5,7,14,21,28 | NFS, TP TCA, blood ionogram and hepatic check-up, glycemia. This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 |
| Secondary | Define the optimal dose of CPZ and its tolerance: ECG abnormalities | day: 3,5,7,14,21,28 | Rate of patients with ECG abnormalities at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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