Pilot trial on early treatment with hydroxychloroquine in patients withCOVID-19 who do not have hospital admission at diagnosis. - PRE-COVID

ANTONIO ANTELA LOPEZ0 个研究点目标入组 340 人开始时间: 2020年7月22日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Ability of understanding the terms of the trial and
•willingness to participate.
•2. Signature of the informed consent or oral consent with subsequent written confirmation in accordance with the provisions of section 8.4.1 of the study protocol.
•3. Age =50 years.
•4. SARS-CoV-2 positive PCR in nasopharyngeal and / or oropharyngeal or sputum specimen.
•5. Duration of symptoms = 5 days.
•6. Absence of contraindications to the use of hydroxychloroquine: intolerance, allergy, major interactions with home 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 340
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 340

•1. Indication of hospital admission, defined by:
•to. Presence of pulmonary infiltrate or significant hypoxemia (pO2 <70, SO2 <95%).
•b. Symptoms suggestive of lower respiratory involvement (increasing cough, dyspnea and / or pleuritic pain), even in the absence of radiological or gasometric criteria, according to clinical criteria.
•c. Any other justification that at the discretion of the investigator motivates hospital admission.
•2. Current treatment or in the last 14 days with hydroxychloroquine for any indication.
•3. History of ischemic heart disease, bradyarrhythmias, ventricular arrhythmias, preexcitation syndrome (Wolf-Parkinson-White syndrome), patients receiving antiarrhythmic drugs or defibrillator carriers.
•4. Baseline QTc = 470 ms in men or = 480 ms in women (on current ECG or on ECG of the 3 months prior to study inclusion).
•5. Current treatment with drugs that can prolong the QT interval, such as: loperamide, antiemetics, antipsychotics, antidepressants, cilostazol, donezepil, alfuzosin, solifenacin, quinolones, azoles, opiates. According to medical criteria, a temporary discontinuation of the previous treatment may be assessed, if it is the only limiting factor for participation in the study and its discontinuation or replacement does not pose a risk to the patient.
•6. Patients who are participating in another clinical trial.

发起方

ANTONIO ANTELA LOPEZ