SARS-CoV-2 infection MedDRA version: 20.0 Level: PT Classification code 10049924 Term: Infection prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Hidroxicloroquina Aristo
Product Name: Hidroxicloroquina sulfato
Pharmaceutical Form: Coated tablet
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
CAS Number: 747-36-4
Current Sponsor cod
Sponsors
Sociedad Española de Farmacia Hospitalaria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Absence of SARS-CoV-2 infection (COVID-19) due to the absence of a symptoms of acute respiratory infection or a diagnostic test with a negative result. 2. Men or women 18 years of age or older at the time of signing the informed consent. 3. For fertile women, negative pregnancy test and written commitment to use a reliable contraceptive method for the duration of the study and for 3 months after the end of treatment. 4. Health care workers active at the center. 5. Informed consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2163 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Health care workers previously treated with hydroxycloroquine in the 60 days before. 2. Health care workers participating in another clinical study where they received an investigational drug in the 24 weeks before to signing the informed consent. 3. Pregnant or lactating women. 4. Postmenopausal women 5. Psoriasis. 6. Retinopathy, maculopathy or changes in the visual field, regardless of its origin. 7. Neurogenic hearing impairment. 8. Myasthenia gravis. 9. Disease of the hematopoietic system. 10. Glucose-6-phosphate dehydrogenase deficiency (eg hemolytic anemia or favism). 11. Hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives. 12. Inability to take oral medication. 13. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study. 14. Consumption of alcohol or any other drug that could disable him in the judgment of the investigator to participate in the study. 15. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of hydroxychloroquine as chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals by negative PCR.;Secondary Objective: To assess the safety of hydroxychloroquine as chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals. To assess the efficacy of personal protective equipment against SARS-CoV-2 (COVID-19) infection in healthcare professionals;Primary end point(s): Diagnosis of SARS-CoV-2 COVID-19 infection;Timepoint(s) of evaluation of this end point: - At the end of prophylaxis treatment - Fourteen days after the last dose of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse event reported - Diagnosis of SARS-CoV-2 COVID-19 infection;Timepoint(s) of evaluation of this end point: - At the end of prophylaxis treatment - Fourteen days after the last dose of treatment | — |
Countries
Spain
Contacts
Public ContactEmilio Garcia Cabrera
Delos Clinical
Outcome results
None listed