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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT04428268
Eligibility Criteria:
Inclusion Criteria:
1. Men or women ≥18 years.
2. Oral tolerance or access for enteral administration of medication.
3. PCR or IgM for SARS-CoV-2 positive.
4. Negative pregnancy test in case of a woman of reproductive age.
5. Signature of a document proving informed consent.
6. Hospital admission for SARS-CoV-2 pneumonia.
Exclusion Criteria:
1. New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
2. Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
3. History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
4. Known patient with hearing loss.
5. Received chloroquine or hydroxychloroquine in the last 3 months.
6. Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
7. Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) \< 30ml/min 1.73 m2.
8. Patients known to be deficient in 6-phosphate dehydrogenase
9. Patients known to have retinopathy or macular disease.
10. History of acute myocardial infarction in the last 6 months, unstable angina, ventricular tachycardia, ventricular fibrillation or class III-IV heart failure according to New York Heart Association.
11. Electrocardiogram QTc interval ≥ 480 ms.
12. Patients with hypomagnesemia or uncorrected hypokalemia.
13. Patients with a history of psychiatric illness.
14. Patients who are pregnant or nursing.
15. Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
16. Patients with acute pancreatitis.
17. Patients who the investigators deem unsuitable for participation in the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04428268
Study Brief:
Protocol Section:
NCT04428268