Covid 19 Research using Clinical Trials (Home Page)
CHLORPROMAZINE (CPZ)Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug157 | COVID-19 infection Wiki | 1.00 |
| drug773 | Standard of Care (SOC) Wiki | 1.00 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001167 | Arteritis NIH | 1.00 |
| D025241 | Spondylarthritis NIH | 1.00 |
| D011111 | Polymyalgia Rheumatica NIH | 1.00 |
| D013700 | Giant Cell Arteritis NIH | 1.00 |
| D003095 | Collagen Diseases NIH | 0.71 |
| D015535 | Arthritis, Psoriatic NIH | 0.71 |
| D012216 | Rheumatic Diseases NIH | 0.71 |
| D001168 | Arthritis NIH | 0.58 |
| D008180 | Lupus Erythematosus, Systemic NIH | 0.58 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 Repurposing of Chlorpromazine in Covid-19 Treatment
This study evaluates the effects of the addition of chlorpromazine to the standard therapeutic protocol in COVID-19 patients hospitalized for respiratory symptom management (score 3-5 WHO Ordinal Scale for Clinical Improvement).
NCT04366739 COVID-19 Drug: CHLORPROMAZINE (CPZ) Combination Product: Standard of Care (SOC)
Primary Outcomes
Description: 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.
Measure: Time To Response (TTR) Time: 28 daysSecondary Outcomes
Description: 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).
Measure: Objective Response Rate (ORR) Time: 28 days from randomizationDescription: All-cause mortality rates at Day 28th after randomization
Measure: All-cause mortality Time: 28 days after randomizationDescription: This will be a continuous outcome defined by the amount of time in days between randomization and the hospital discharge
Measure: Duration in days required for hospital discharge Time: 28 days after randomizationDescription: 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.
Measure: Duration in days required for National Early Warning Score ≤ 2 maintained 24 hours Time: 28 days after randomizationDescription: This will be a continuous outcome defined by the amount of time in days without oxygen therapy
Measure: Number of days without oxygen therapy Time: 28 days after randomizationDescription: Number of clinical conditions that need a prescription for Oxygen therapy, NIV or high flow oxygen therapy
Measure: Incidence of oxygen use, NIV or high flow oxygen therapy Time: 28 days after randomizationDescription: This will be a continuous outcome defined by the amount of time in days with oxygen therapy, NIV, or high flow oxygen therapy.
Measure: Duration in days of oxygen prescription, NIV or high flow oxygen therapy Time: 28 days after randomizationDescription: 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
Measure: Biochemical response: rate of patients positive for SARS-CoV-2 PCR on a nasopharyngeal sample Time: day 7 from randomizationDescription: This will be a quantitative variable. Biobank sample at day 7
Measure: Biochemical response: viral load of SARS-CoV-2 on a nasopharyngeal sample Time: day 7 from randomizationDescription: This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28
Measure: Biochemical response: serum viral load of SARS-CoV-2 Time: day: 3,5,7,14,21,28Description: This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28
Measure: Biochemical response: C-reactive protein (CRP) Time: day: 3,5,7,14,21,28Description: This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28
Measure: Biochemical response: blood test for lymphocytes (lymphopenia) Time: day: 3,5,7,14,21,28Description: Extension score of parenchymal involvement in thoracic computed tomography (CT) (D7)
Measure: Parenchymal involvement (chest CT) Time: day 7Description: Rates of serious adverse events
Measure: Define the optimal dose of CPZ and its tolerance: rates of serious adverse events Time: 28 daysDescription: Rates of non-serious side effects
Measure: Define the optimal dose of CPZ and its tolerance: rates of non-serious side effects Time: 28 daysDescription: 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.
Measure: Define the optimal dose of CPZ and its tolerance: anxiety assessment on Global Anxiety - Visual Analog Scale (GA-VAS) Time: 28 daysDescription: Rates of drug discontinuation in all causes under study
Measure: Define the optimal dose of CPZ and its tolerance: Rates of drug discontinuation Time: 28 daysDescription: 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
Measure: Define the optimal dose of CPZ and its tolerance: biological anomalies Time: day: 3,5,7,14,21,28Description: Rate of patients with ECG abnormalities at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28
Measure: Define the optimal dose of CPZ and its tolerance: ECG abnormalities Time: day: 3,5,7,14,21,28Description: plasma CPK assessment at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28
Measure: Define the optimal dose of CPZ and its tolerance: plasma CPK assessment Time: day: 3,5,7,14,21,28Description: Plasma CPZ assessment at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28
Measure: Define the optimal dose of CPZ and its tolerance:plasma CPZ assessment Time: day: 3,5,7,14,21,28Description: CPZ dosages administered
Measure: Define the optimal dose of CPZ and its tolerance: CPZ dose administered Time: 28 daysOther Outcomes
Description: Biobank by blood samples of 20 ml per patient (on D1, D3, D5, D7, then, if continued hospitalization at D14, D21, D28) allowing, in addition to viral markers:Cytokine and lymphocyte profile assays in flow cytometry: IL-2, IL-6, IL-7, IL-10, GCSF, IP10, MCP1, M1P1A and TNF-alfa, FACs CD3, CD4, CD8, CD38
Measure: Evaluate the biological parameters to treatment response (biobank constitution for carrying out cytokine assays, lymphocyte profiles in flow cytometry and additional explorations according to the evolution of knowledge on COVID-19) Time: day: 1, 3,5,7,14,21,28