Hydro Trial - Phase 1b and a Phase 3 study Seem
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Posted On: 04/10/2020 2:49:35 PM
Hydro Trial - Phase 1b and a Phase 3 study
Seems two trials similar to Leronlimab, first study no severe patients allowed, still not seeing our trials ?
phase 1b study
Criteria
Inclusion criteria :
Participants with diagnosis of COVID-19 via nasopharyngeal swab Polymerase Chain Reaction (PCR)
Time between onset of symptoms and enrollment is 72 hours or less
Exclusion criteria:
Severe COVID-19 requiring inpatient treatment
Women who are pregnant or breastfeeding
Concurrent antimicrobial therapy
Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
Hydroxychloroquine use within 2 months before enrollment
History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis
History of retinopathy
History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death
History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
phase 3 study
Criteria
Inclusion Criteria:
Hospitalization for management of SARS CoV-2 infection
Positive SARS CoV-2 test
Age >=18 years
Provision of informed consent
Electrocardiogram (ECG) ≤48 hours prior to enrollment
Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.
If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
Condom (male or female) with or without spermicide
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormone-based contraceptive
Exclusion Criteria:
Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
Current use hydroxychloroquine, chloroquine or azithromycin
Concurrent use of another investigational agent
Invasive mechanical ventilation
Participants who have any severe and/or uncontrolled medical conditions such as:
unstable angina pectoris,
symptomatic congestive heart failure,
myocardial infarction,
cardiac arrhythmias or know prolonged QTc >470 males, >480 female on ECG
pulmonary insufficiency,
epilepsy (interaction with chloroquine),
Prior retinal eye disease
Concurrent malignancy requiring chemotherapy
Known Chronic Kidney disease, eGFR<10 or dialysis
G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
Known Porphyria
Known myasthenia gravis
Currently pregnant or planning on getting pregnant while on study
Breast feeding
AST/ALT >five times the upper limit of normal ULN*
Bilirubin >five times the ULN*
Magnesium <1.4 mEq/L*
Calcium <8.4mg/dL >10.6mg/dL*
Potassium <3.3 >5.5 mEg/L*
Seems two trials similar to Leronlimab, first study no severe patients allowed, still not seeing our trials ?
phase 1b study
Criteria
Inclusion criteria :
Participants with diagnosis of COVID-19 via nasopharyngeal swab Polymerase Chain Reaction (PCR)
Time between onset of symptoms and enrollment is 72 hours or less
Exclusion criteria:
Severe COVID-19 requiring inpatient treatment
Women who are pregnant or breastfeeding
Concurrent antimicrobial therapy
Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
Hydroxychloroquine use within 2 months before enrollment
History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis
History of retinopathy
History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death
History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
phase 3 study
Criteria
Inclusion Criteria:
Hospitalization for management of SARS CoV-2 infection
Positive SARS CoV-2 test
Age >=18 years
Provision of informed consent
Electrocardiogram (ECG) ≤48 hours prior to enrollment
Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.
If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
Condom (male or female) with or without spermicide
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormone-based contraceptive
Exclusion Criteria:
Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
Current use hydroxychloroquine, chloroquine or azithromycin
Concurrent use of another investigational agent
Invasive mechanical ventilation
Participants who have any severe and/or uncontrolled medical conditions such as:
unstable angina pectoris,
symptomatic congestive heart failure,
myocardial infarction,
cardiac arrhythmias or know prolonged QTc >470 males, >480 female on ECG
pulmonary insufficiency,
epilepsy (interaction with chloroquine),
Prior retinal eye disease
Concurrent malignancy requiring chemotherapy
Known Chronic Kidney disease, eGFR<10 or dialysis
G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
Known Porphyria
Known myasthenia gravis
Currently pregnant or planning on getting pregnant while on study
Breast feeding
AST/ALT >five times the upper limit of normal ULN*
Bilirubin >five times the ULN*
Magnesium <1.4 mEq/L*
Calcium <8.4mg/dL >10.6mg/dL*
Potassium <3.3 >5.5 mEg/L*
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