Status:
COMPLETED
Favipiravir vs Hydroxychloroquine vs Control in COVID -19
Lead Sponsor:
Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborating Sponsors:
Ebrahim Khalil Kanoo Community Medical Center
Hereditary blood Disorder Centre - Salmaniya Medical Complex
Conditions:
SARS-CoV 2
COVID-19
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Hydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has found that a high concentration of cytokines were detected in the plasma of critically ill patients infected ...
Detailed Description
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2/2019-nCoV) and has developed into a pandemic with serious global public health and econ...
Eligibility Criteria
Inclusion
- Admitted COVID-19 patients being treated as an in-patient at a hospital facility.
- COVID-19 diagnosis confirmed by PCR nasopharyngeal swab.
- Study participants must be symptomatic with any COVID-19 symptoms defined by the Bahrain National Protocol
- Onset of symptoms must be within 10 days prior to enrolment.
- Study participants must have the ability to give informed consent.
- Participants must be at minimum 21 years of age.
- Mild to Moderate COVID-19 disease defined as saturation equals to or more than 93% on room air or PaO2:FiO2 ratio more than 300 on enrolment.
Exclusion
- Severe COVID-19 disease: defined as presence of SpO₂ less than 93% on room air or a PaO₂ to FiO₂ ratio of 300 or lower.
- Patients on ventilatory support.
- Cardiac dysfunction that would preclude treatment with hydroxychloroquine:
- Patients on medication known to prolong QT segment.
- Known history of LQT syndrome.
- Acquired QT prolongation at baseline \>500ms.
- AV block.
- Bundle Branch Block.
- Known history of Cardiomyopathy, Pulmonary Hypertension, or Sick Sinus Syndrome.
- History of ventricular tachyarrhythmia.
- Patients with implantable cardioverter-defibrillator (ICD).
- Patients with a baseline bradycardia of less than 50 beats per minute.
- Renal dysfunction (estimated glomerular filtration rate less than 30ml/min).
- Hepatic dysfunction defined as:
- Transaminitis more than three times the upper limit of normal or
- Chronic liver disease of Child Pugh Class B or higher.
- Gout or a history of gout
- Patients that are pregnant or breastfeeding.
- Patients with a known allergy to an intervention medication.
- Patients who receive any of the study medications prior to randomization
- Patient with G6PD
- Readmission due to COVID19 disease.
- Participants in any other COVID-19 disease trial.
- Patients on immunosuppressants, HIV patients, cancer patients who received chemotherapy within the past 6 months, or who are on chronic oral steroids.
- Patients unable to give informed consent.
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04387760
Start Date
August 11 2020
End Date
April 7 2021
Last Update
October 26 2021
Active Locations (1)
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1
Royal College of Surgeons in Ireland - Bahrain
Manama, Bahrain