Covid 19 Research using Clinical Trials (Home Page)
Standard of Care (SOC)Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2269 | Sirukumab Wiki | 0.58 |
| drug434 | CHLORPROMAZINE (CPZ) Wiki | 0.58 |
| drug1225 | Interferon-ß-1a Wiki | 0.58 |
| drug2187 | Saliva collection Wiki | 0.26 |
| drug2388 | Survey Wiki | 0.22 |
| drug1822 | Placebo Wiki | 0.03 |
There are 3 clinical trials
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, 3,5,7,14,21,282 Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease
The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.
NCT04380961 Severe or Critical Confirmed Coronavirus Disease (COVID)-19 Drug: Sirukumab Drug: Placebo Other: Standard of Care (SOC) MeSH:Coronavirus Infections
Primary Outcomes
Description: Time to improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale. The 6-point ordinal clinical recovery scale provides 6 mutually exclusive conditions ordered from best to worst, and the score reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are : not hospitalized (category 1); Hospitalization; not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO (category 5); death (category 6).
Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale Time: Up to Day 28Secondary Outcomes
Description: Percentage of participants with an improvement of at Least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.
Measure: Percentage of Participants with an Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28 Time: Day 28Description: Percentage of participants with all-cause mortality will be reported.
Measure: Percentage of Participants with All-cause Mortality Time: Up to Day 28Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.
Measure: Percentage of Participants with Serious Adverse Events (SAEs) Time: Up to Day 28Description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Percentage of Participants with Related Adverse Events Time: Up to Day 28Description: Percentage of participants with severe or life-threatening, bacterial, invasive fungal, viral or opportunistic infections (other than severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) will be reported.
Measure: Percentage of Participants with Severe or Life Threatening Bacterial, Invasive Fungal, Viral or Opportunistic Infections Time: Up to Day 28Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) neutropenia will be reported.
Measure: Percentage of Participants with Grade 3 and 4 Neutropenia Time: Up to Day 28Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) lymphocytopenia will be reported.
Measure: Percentage of Participants with Grade 3 and 4 Lymphocytopenia Time: Up to Day 28Description: Percentage of participants with increased ALT >=3 times ULN combined with increased bilirubin >2 times ULN (up to Day 28) will be reported.
Measure: Percentage of Participants with Increased Alanine Aminotransferase (ALT) Greater than or equal to 3 Times Upper Limit of Normal (ULN) Combined with Increased Bilirubin > 2 Times ULN Time: Up to Day 28Description: Time to improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale will be reported.
Measure: Time to Improvement of at least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale Time: Up to Day 28Description: Percentage of participants with an improvement of at Least 1 category relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.
Measure: Percentage of Participants with an Improvement of at Least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28 Time: Day 28Description: Time from study intervention to end of oxygen supplementation is defined as achieving category 1 or 2 on the 6-point ordinal clinical recovery scale.
Measure: Time from Study Intervention to end of Oxygen Supplementation Time: Up to Day 28Description: Time from study intervention to hospital discharge among the surviving participants will be reported.
Measure: Time from Study Intervention to Hospital Discharge Among the Surviving Participants Time: Up to Day 28Description: Total length of hospitalization (days from admission to hospital discharge) among the surviving participants will be reported.
Measure: Total Length of Hospitalization Time: Up to Day 28Description: Number of Ventilation free Days will be reported.
Measure: Number of Ventilation Free Days Time: Up to Day 28Description: Participant's clinical status at Day 7, 14, 21, 28 will be assessed by 6-point ordinal clinical recovery scale.
Measure: Participant's Clinical Status at Day 7, 14, 21, 28 as Assessed by 6-Point Ordinal Clinical Recovery Scale Time: Day 7, 14, 21, 28Description: Total time on invasive mechanical ventilation will be reported.
Measure: Total Time on Invasive Mechanical Ventilation Time: Up to Day 28Description: Percentage of participants with a worsening of at least 1 category on the 6-point ordinal clinical recovery scale over time (between Day 5 and Day 28) will be reported.
Measure: Percentage of Participants with a Worse Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale over Time Time: From Day 5 up to Day 28Description: Percentage participants on ECMO over time will be reported.
Measure: Percentage of Participants on Extracorporeal Membrane Oxygenation (ECMO) Over Time Time: Up to Day 28Description: Total time on ECMO will be reported.
Measure: Total Time on ECMO Time: Up to Day 28Description: Percentage of alive participants at Day 28, Week 8 and Week 16 will be reported.
Measure: Percentage of Alive Participants at Day 28, Week 8 and Week 16 Time: Day 28, Week 8 and Week 16Description: Percentage of alive participants that required readmission (if previously discharged) at Week 8 and Week 16 will be reported.
Measure: Percentage of Alive Participants that Required Readmission at Week 8 and Week 16 Time: Week 8 and Week 16Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.
Measure: Percentage of Participants with Serious Adverse Events (SAEs) Time: Up to Week 163 Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients
Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage. The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial. The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone. The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.
NCT04449380 COVID-19 Virus Infection Drug: Interferon-ß-1a Combination Product: Standard of Care (SOC) MeSH:Virus Diseases
Primary Outcomes
Description: Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)
Measure: Time to negative conversion of SARS-CoV-2 nasopharyngeal swab Time: From baseline to day 29Secondary Outcomes
Description: Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale
Measure: Improvement in clinical severity score (a) Time: Baseline, days 7, 15, 21, 29Description: Defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital, whichever comes first
Measure: Improvement in clinical severity score (b) Time: Baseline, days 7, 15, 21, 29Measure: Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial Time: From baseline to day 29
Measure: Oxygenation free days in the first 28 days Time: From baseline to day 29
Measure: Ventilator free days in the first 28 days Time: From baseline to day 29
Measure: Incidence of new mechanical ventilation use during the trial Time: From baseline to day 29
Measure: Number of patients transferred to Intensive Care Unit (ICU) Time: From baseline to day 29
Measure: Mortality rate Time: From baseline to day 29
Description: Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)
Measure: Changes from baseline in pulmonary computed tomography (CT) imaging severity score Time: Baseline, day 21; extra follow up at 90 daysMeasure: Duration of hospital stay expressed in days Time: From baseline to day 29
Measure: Viral load measured on plasma with RT-PCR Time: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29
Other Outcomes
Measure: Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG) Time: Baseline, day 15Measure: Antibodies to SARS-CoV-2 Time: Baseline, days 7, 15, 29
Measure: Antibodies to IFN-β1a Time: Baseline, days 7, 15, 29