Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04387760
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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:
1. Patients on medication known to prolong QT segment.
2. Known history of LQT syndrome.
3. Acquired QT prolongation at baseline \>500ms.
4. AV block.
5. Bundle Branch Block.
6. Known history of Cardiomyopathy, Pulmonary Hypertension, or Sick Sinus Syndrome.
7. History of ventricular tachyarrhythmia.
8. Patients with implantable cardioverter-defibrillator (ICD).
9. 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:
1. Transaminitis more than three times the upper limit of normal or
2. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04387760
Study Brief:
Protocol Section:
NCT04387760