Status:
WITHDRAWN
Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to COVID-19
Lead Sponsor:
Universidad Nacional de Colombia
Collaborating Sponsors:
Fundación Salud de los Andes
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a PILOT STUDY, a Phase III double-blind, randomized, placebo-controlled clinical study in which we assess the clinical effect of the prophylactic administration of hydroxychloroquine vs. place...
Detailed Description
The personnel responsible for caring of patients infected by the SARS-CoV-2 virus: doctors, nurses and paramedics working at Intensive Care Units (ICUs)), are at high risk of SARS-CoV-2 infection. Epi...
Eligibility Criteria
Inclusion
- Be part of the health personnel (intensivist doctor, hospital doctors, nurses, physical therapists and support staff in the care unit) who will work at the HUN in the period of May 1st, 2020 to August 1, 2020
- Be over 18 years old, exposed to patients with COVID-19. Not having symptoms compatible with an acute respiratory infection for the last 21 days.
- Willingness to donate blood samples and for diagnosis and monitoring of SARS-COV-2 infection throughout the study period.
- Have a Smart Phone in order to facilitate permanent communication with you during the duration of the study.
- Signature of informed consent.
Exclusion
- Allergy or hypersensitivity to hydroxychloroquine.
- Contraindications to the use of chloroquine (epilepsy, creatinine clearance \<30mL / min).
- Be taking (Abiraterone Acetate, Agalsidase, Conivaptan, Dabrafenib, Dacomitinib, Enzalutamide, Idelalisib), or medications that cannot be discontinued.
- Retinal disease.
- Mifepristone, Mitotane, tiripentol.
- Already established hydroxychloroquine treatment.
- Pregnancy or suspected pregnancy.
- Women in breastfeeding.
- Chronic liver disease (Child-Pugh B or C).
- Kidney disease with a Glomerular Filtration Rate of less than or equal to 30mL / min.
- Cardiac, kidney, liver, ophthalmic, neurological or autoimmune disease previously diagnosed.
- Prolongation of the QT segment in the EKG.
- Previous diagnosis of COVID-19.
- Concomitant taking of medications that prolong the QT segment
Key Trial Info
Start Date :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04346329
Start Date
March 30 2020
End Date
October 30 2020
Last Update
May 5 2021
Active Locations (2)
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1
Facultad de Medicina - Universidad Nacional de Colombia
Bogota, Cundinamarca, Colombia, 111321
2
Universidad Nacional de Colombia
Bogota, Cundinamarca, Colombia, 111321