Covid 19 Research using Clinical Trials (Home Page)
Aerolized Hydroxychloroquine SulfateWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2948 | photobiomodulation and photodynamic therapy Wiki | 1.00 |
| drug1822 | Placebo Wiki | 0.06 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Phase 1 Randomized Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: - To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. - To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
NCT04461353 Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Aerolized Hydroxychloroquine Sulfate Other: Placebo MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: TEAEs (defined as AEs with onset after study drug administration or existing AEs that worsen in severity after study drug administration)
Measure: Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0 Time: after treatment (Day 1) through to Day 30Description: Blood sample collected for CBC with differential will be assessed from baseline (at screening)
Measure: Change from baseline in clinical laboratory test results for CBC with differential Time: Screening and Day 8Description: Screening blood sample collected for CBC with differential, counting the number of abnormal clinical tests
Measure: Incidence of abnormal laboratory test results for CBC with differential at Screening Time: ScreeningDescription: Day 8 blood sample collected for CBC with differential
Measure: Incidence of abnormal laboratory test results for CBC with differential - Day 8 Time: Day 8Description: Blood sample collected for blood glucose and measured with a glucometer
Measure: Changes from baseline for blood glucose Time: Screening and Day 1Description: Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Measure: Incidence of abnormal laboratory test results for chemistry -Screening Time: ScreeningDescription: Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Measure: Incidence of abnormal laboratory tests results for chemistry - Day 8 Time: Day 8Description: Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Measure: Incidence of abnormal laboratory tests results for urinalysis - Screening Time: ScreeningDescription: Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Measure: Incidence of abnormal laboratory tests results for urinalysis- Day 8 Time: Day 8Description: The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (September 2007) (TGSHAAV) will be used as the primary criteria for assessment of clinical abnormalities. Mild (17-20 breaths per minute) to Potentially Life Threatening (intubation)
Measure: Changes in vital signs from baseline (pre-dose) - respiratory rate Time: Screening, Day 1, Day 2 and Day 8Description: Oral temperature
Measure: Changes in vital signs from baseline (pre-dose)- temperature Time: Screening, Day 1, Day 2 and Day 8Description: Systolic and diastolic blood pressure
Measure: Changes in vital signs from baseline (pre-dose) - seated blood pressure Time: Screening, Day 1, Day 2 and Day 8Description: Heart rate measure by radial pulse rate (beats/min)
Measure: Changes in vital signs from baseline (pre-dose) - pulse Time: Screening, Day 1, Day 2 and Day 8Description: O2 saturation (%), measured by pulse oximeter. Graded as per TGSHAAV (September 2007) from Moderate (pulse oximeter <92%) to Potentially Life Threatening (Life-threatening airway compromise; urgent intervention indicated)
Measure: Changes in vital signs from baseline (pre-dose) - O2 saturation Time: Screening, Day 1, Day 2 and Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- general appearance Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - general appearance Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- general appearance Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- general appearance Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- neurological Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1- neurological Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- neurological Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- neurological Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular Time: Day 1 (pre-dose, within 3 hours of dose)Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening - lungs Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - lungs Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - lungs Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8 - lungs Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- abdomen Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - abdomen Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- abdomen Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- abdomen Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during screening- endocrine Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - endocrine Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- endocrine Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- endocrine Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- extremities Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1- extremities Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- extremities Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- extremities Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- lymphatic Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1- lymphatic Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - lymphatic Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- lymphatic Time: Day 8Description: A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during screening - skin Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - skin Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - skin Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8 - skin Time: Day 8Description: Pulmonary function testing and recording of FEV1, both actual and percent predicted
Measure: Changes from baseline for pulmonary function tests (PFTs) - FEV1 Time: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.Description: Pulmonary function testing and recording of FVC, , both actual and percent predicted
Measure: Changes from baseline for pulmonary function tests (PFTs) - FVC Time: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.Description: Pulmonary function testing and recording of FEV1/FVC
Measure: Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC Time: creening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - QT interval Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QTcB interval (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - QTcB Interval Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QRS duration (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - QRS duration Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG PR interval (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - PR interval Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG heart rate (beats/min) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - heart rate Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG - Screening Time: ScreeningDescription: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG- Day 1 Time: Day 1 pre-dose (within 3 hours of dose) and +2 and +6 hoursDescription: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG - Day 2 Time: Days 2Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG - Day 8 Time: Days 8.Secondary Outcomes
Description: Blood samples for PK analysis will be collected via indwelling catheter or via direct venipuncture.
Measure: HCQ concentration in whole blood versus time profiles Time: Day 1 pre-dose (time 0) and +2, +3, +5, and +15 minutes after dose, and also +1, +2, +4 and +6 hours post-dose completion. Day 2 (+24±4 hours post dose) and Day 8.