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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT04361461
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged \> 18 years;
* Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea);
* Diagnosis confirmed by real-time PCR or suspected COVID-19;
* Hospitalized patients with:
* Moderate disease: hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%;
or
* Serious illness: Hospitalized patients with hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation.
Exclusion Criteria:
* Mild cases of flu-like syndrome that do not require hospitalization or O2 saturation greater than or equal to 93% and without radiological evidence of pneumonia;
* Liver failure or elevation of transaminases greater than 5 times;
* Cardiac patients with electrocardiogram with extended QT interval;
* Pregnant women;
* Use in the last 30 days of hydroxychloroquine or azithromycin;
* Allergy to hydroxychloroquine or azithromycin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04361461
Study Brief:
Protocol Section:
NCT04361461