COVID-19 Clinical Trial
— reCoVeryOfficial title:
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).
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | September 30, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Biological and/or radiological diagnosis of COVID-19 infection - WHO-OSCI at 3, 4 or 5 at the time of inclusion - Benefiting from a social security scheme - Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures Exclusion Criteria: - Treatment with chlorpromazine (CPZ) the month preceding the inclusion visit - Contraindication to the CPZ: - Hypersensitivity to the active substance or any of the excipients - Risk of glaucoma by closing the angle. - Risk of urinary retention linked to urethroprostatic disorders. - History of agranulocytosis - Association with dopaminergic outside Parkinson's (cabergoline, quinagolide), citalopram, escitalopram, domperidone, hydroxyzine, and piperaquine - Wheat allergy - Risk of QT prolongation and occurrence of severe ventricular rhythm disorders: the existence of bradycardia, hypokalaemia, long congenital or acquired QT - History of ischemic stroke - Treatment with chloroquine or hydroxychloroquine during the inclusion visit or the previous month - Need for mechanical ventilation linked to COVID-19, during the inclusion visit or the last month - In the opinion of the clinical team, imminent progression to death within the next 24 hours regardless of treatment - Psychiatric care under duress - Protected adults, persons under the protection of justice - Pregnant or lactating woman |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Sainte-Anne | Paris |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier St Anne | Hôpital Cochin |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | 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 | day: 1, 3,5,7,14,21,28 | |
Primary | Time To Response (TTR) | 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. |
28 days | |
Secondary | Objective Response Rate (ORR) | 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). |
28 days from randomization | |
Secondary | All-cause mortality | All-cause mortality rates at Day 28th after randomization | 28 days after randomization | |
Secondary | Duration in days required for hospital discharge | This will be a continuous outcome defined by the amount of time in days between randomization and the hospital discharge | 28 days after randomization | |
Secondary | Duration in days required for National Early Warning Score = 2 maintained 24 hours | 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. |
28 days after randomization | |
Secondary | Number of days without oxygen therapy | This will be a continuous outcome defined by the amount of time in days without oxygen therapy | 28 days after randomization | |
Secondary | Incidence of oxygen use, NIV or high flow oxygen therapy | Number of clinical conditions that need a prescription for Oxygen therapy, NIV or high flow oxygen therapy | 28 days after randomization | |
Secondary | Duration in days of oxygen prescription, NIV or high flow oxygen therapy | This will be a continuous outcome defined by the amount of time in days with oxygen therapy, NIV, or high flow oxygen therapy. | 28 days after randomization | |
Secondary | Biochemical response: rate of patients positive for SARS-CoV-2 PCR on a nasopharyngeal sample | 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 | day 7 from randomization | |
Secondary | Biochemical response: viral load of SARS-CoV-2 on a nasopharyngeal sample | This will be a quantitative variable. Biobank sample at day 7 | day 7 from randomization | |
Secondary | Biochemical response: serum viral load of SARS-CoV-2 | This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 | day: 3,5,7,14,21,28 | |
Secondary | Biochemical response: C-reactive protein (CRP) | This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 | day: 3,5,7,14,21,28 | |
Secondary | Biochemical response: blood test for lymphocytes (lymphopenia) | This will be a quantitative variable. Biobank blood sample at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 | day: 3,5,7,14,21,28 | |
Secondary | Parenchymal involvement (chest CT) | Extension score of parenchymal involvement in thoracic computed tomography (CT) (D7) | day 7 | |
Secondary | Define the optimal dose of CPZ and its tolerance: rates of serious adverse events | Rates of serious adverse events | 28 days | |
Secondary | Define the optimal dose of CPZ and its tolerance: rates of non-serious side effects | Rates of non-serious side effects | 28 days | |
Secondary | Define the optimal dose of CPZ and its tolerance: anxiety assessment on Global Anxiety - Visual Analog Scale (GA-VAS) | 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. |
28 days | |
Secondary | Define the optimal dose of CPZ and its tolerance: Rates of drug discontinuation | Rates of drug discontinuation in all causes under study | 28 days | |
Secondary | Define the optimal dose of CPZ and its tolerance: biological anomalies | 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 | day: 3,5,7,14,21,28 | |
Secondary | Define the optimal dose of CPZ and its tolerance: ECG abnormalities | Rate of patients with ECG abnormalities at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 | day: 3,5,7,14,21,28 | |
Secondary | Define the optimal dose of CPZ and its tolerance: plasma CPK assessment | plasma CPK assessment at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 | day: 3,5,7,14,21,28 | |
Secondary | Define the optimal dose of CPZ and its tolerance:plasma CPZ assessment | Plasma CPZ assessment at D3, D5, D7 then, if hospitalization continues blood sample at D14, D21, and D28 | day: 3,5,7,14,21,28 | |
Secondary | Define the optimal dose of CPZ and its tolerance: CPZ dose administered | CPZ dosages administered | 28 days |
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