Status:
UNKNOWN
Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers.
Lead Sponsor:
Services Institute of Medical Sciences, Pakistan
Conditions:
SARS-CoV-2
Healthcare Workers
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measu...
Detailed Description
An interventional randomised control trial that will include 374 participants who will be healthcare workers at variable risks of exposure to SARS-CoV-2 while managing patients both suspected and conf...
Eligibility Criteria
Inclusion
- Adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent.
- Healthcare workers (doctors and nurses) at Services hospital, Lahore considered work at high-risk of SARS-CoV-2 exposure (defined below):
- Healthcare workers in Corona triage areas.
- Healthcare workers in Corona Isolation Units.
- Healthcare workers in Corona ICUs.
- Healthcare workers in general medical wards.
- Healthcare workers in general surgical wards.
- Healthcare workers in other units not directly dealing with suspected Corona patients e.g. Endocrinology department
- Afebrile with no constitutional symptoms.
- No household contact with confirmed active SARS-CoV-2 infection in the last 3 weeks.
- Negative PCR at visit 0.
- Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Willing to not take any other medicines especially fluoroquinolones and macrolides for the duration of study.
- Signed informed consent, demonstrating that the subject understands the interventions required for the study and the purpose of the study.
Exclusion
- Participation in other investigational clinical trials for the treatment or prevention of SARS-CoV-2 infection within 30days.
- Subjects unwilling to practice at least one highly effective method of birth control for the duration of the study.
- Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
- Having H/O skin disorders e.g. dermatitis, psoriasis or porphyria.
- Taking any of the following medication:
- Anti-arrythmic agents including digoxin.
- GI drugs including antacids, proton-pump inhibitors, cimetidine.
- Anti-cancer treatment including methotrexate, cyclosporin.
- Anti-diabetic agents including insulin.
- Corticosteroids.
- Drugs causing QT interval prolongation especially antidepressants, anti-epileptics and macrolides.
- Drugs affecting electrolyte balance including diuretics, laxatives.
- Drug allergies: 4-Aminoquinolines.
- Pre-existing retinopathy/maculopathy of the eye.
- Known chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis.
- Previous history of severe hypoglycaemia.
- Known case of renal disease.
- Untreated or uncontrolled active bacterial, fungal infection.
- Known or suspected active drug or alcohol abuse.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to any component of the study drug.
- A known history of prolonged QT syndrome or history of additional risk factors for arrythmias (e.g., heart failure, family history of Long QT Syndrome).
- Known H/O respiratory disorders e.g. asthma, chronic obstructive pulmonary disease.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2020
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT04370015
Start Date
May 15 2020
End Date
October 15 2020
Last Update
May 6 2020
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