Status:
UNKNOWN
Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19
Lead Sponsor:
Shaheed Zulfiqar Ali Bhutto Medical University
Conditions:
COVID 19
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are ...
Detailed Description
Study design: Phase 2 proof of concept study Study Type: Interventional (Clinical Trial) Estimated Enrollment : at least 200 participants Since the investigators have no current data on pre-exposure ...
Eligibility Criteria
Inclusion
- Inclusion Criteria after taking a written informed consent:
- A healthcare worker at high risk for COVID19 exposure (defined below):
- Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel) ;
- Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists) ;
- Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists, gastroenterologists performing endoscopy, Pulmonologists performing bronchoscopy);
- First responders (i.e. EMTs, paramedics) ;
- Persons working in the departments of General Medicine, Pulmonology, Infectious disease and Isolation wards.
- Exclusion Criteria:
- Active COVID-19 disease;
- Confirmed prior COVID-19 disease;
- Current fever, cough, shortness of breath;
- Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
- Pregnancy;
- Lactation;
- Prior retinal eye disease;
- Known Chronic Kidney disease, Stage 4 or 5 or dialysis;
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency ;
- Weight \<40 kg;
- Current use of chloroquine,hydroxychloroquine or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone;
- Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen or methotrexate;
- Current use of medications causing QT interval prolongation like: macrolides,antipsychotics,quinolones,antihistamines,SSRIs,tricyclic antidepressants, antifungals;
- Recent Myocardial Infarction;
- History of Epilepsy
Exclusion
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04359537
Start Date
May 1 2020
End Date
September 25 2020
Last Update
May 19 2020
Active Locations (1)
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1
Shaheed Zulfiaqar Ali Bhutto Medical University
Islamabad, Federal Capital, Pakistan, 44000