Hydroxychloroquine for the treatment of mild COVID-19 disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2700

Inclusion Criteria

•Must be =18 years at the time of signing the informed consent
•Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
•Able to adhere to the study visit schedule and other protocol requirements
•Mild COVID-19 with outpatient management as decided by the treating physician
•Early warning score for 2019-nCoV infected patients = 4
•Females of childbearing potential (FCBP) must agree:
oto practice continuous effective contraception for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe (a method which results in a failure rate less than 1% per year)
oto abstain from breastfeeding during study participation and 28 days after study drug discontinuation
•All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment
•All subjects must agree not to share medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

•Requirement for supplemental oxygen
•Shortness of breath in resting position
•Early warning score of 3 in one of the categories:
oRespiratory rate (=8 or =25 breaths/min)
oSystolic blood pressure (=90 mmHg or =220 mmHg)
oHeart rate (=40 or = 130 beats/min)
•Known or suspected renal insufficiency
•Known glucose-6-phosphate-dehydrogenase deficiency (favism)
•Known Myasthenia gravis
•Ongoing disorders of the hemopoietic system
•Known hypersensitivity against 4-amino-quinolines
•Women during pregnancy and lactation
•Current participation in other clinical interventional trials
•Elevated Tisdale score for QTc prolongation (score between 7-21)
•History or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia
•Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)
•Epilepsy
•Physician decision that involvement in the study is not in the patient´s best interest

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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