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:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT04362332
Eligibility Criteria:
Inclusion Criteria:
* \- Patients (≥18 years of age) admitted to the hospital with confirmed COVID-19 and not needing admission to MC or ICU
* Patient has moderate to severe COVID-19. This will be defined as patients with NEWS-2 score ≤ 5.
* Willing and able to give written informed consent
Exclusion Criteria:
* \- Severe Covid-19 defined as NEWS-2 score \>5 or admission to the ICU needing ventilation or pressure support.
* Contra-indications for hydroxychloroquine or chloroquine
* Unable to take oral medication (chloroquine and hydroxychloroquine can be administered through tube feeding which is considered oral administration)
* Identified allergies to 4-aminoquinoline
* Severe diseases of the blood system
* 6-phosphate dehydrogenase deficiency
* History of acute myocardial infarction, unstable angina pectoris, severe arrhythmia (frequent ventricular, ventricular tachycardia, ventricular fibrillation) in recent 6 months; New York Heart Association (NYHA) level III-IV
* Known corrected QT interval (QTc) ≥ 500ms.
* Uncorrected severe hypokalaemia (\< 2,5 mmol/l) or uncorrected severe hypomagnesemia (\< 0.6 mmol/l)
* Pancreatitis
* Refusal to participate expressed by patient or legally authorized representative if they are present
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT04362332
Study Brief:
Protocol Section:
NCT04362332