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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT04715295
Eligibility Criteria:
Inclusion Criteria:
* COVID-19 infection confirmed by SARS-Cov2 - RT PCR - as per protocol
* Able to start the treatment within 24 hours from time of diagnosis
* Patient with mild symptoms as defined by WHO, with PaO2 \> 93%
* Signed written consent of the patient
* Accepts and has the ability to be reached by phone during the study duration, plus a designated a contact person who can be contacted in case of emergency
Exclusion Criteria:
* Blood pressure \< 90/60mm Hg
* Respiratory rate ≥ 30/min
* Known cardiac condition
* Known G6PD deficiency
* Patients with \< 45kg
* eGFR \< 30 ml/min or ALT ≥ 3N or body temperature ≥ 38°C or any life-threatening comorbidity
* Any reason that makes it impossible to monitor the patient during the study period
* Baseline ECG prior to randomization showing QTc \> 500 ms
* Ongoing treatment other than symptomatic
* history of retinopathy
* Absolute contra-indication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment at risk of torsades de pointes)
* Contraindication to any study medication including allergy
* Ongoing treatment with high dose systemic chronic corticosteroid (\> 40 mg)
* Patients treated by immunosuppressants treatment at the time of randomization
* Known Pregnant women and breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04715295
Study Brief:
Protocol Section:
NCT04715295