Pilot trial on early treatment with hydroxychloroquine in patients withCOVID-19 who do not have hospital admission at diagnosis.
- Conditions
- Patients diagnosed with COVID-19, with positive PCR for SARS-CoV-2, without criteria for hospital admission.MedDRA version: 23.0Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002449-41-ES
- Lead Sponsor
- ANTONIO ANTELA LOPEZ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 340
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy in reducing the number of hospital admissions for pneumonia among patients debuting with a mild form of the disease.;Secondary Objective: 1. 60-day mortality.<br>2. Admission to the Intensive Care Unit.<br>3. Safety of hydroxychloroquine treatment in this population;Primary end point(s): Hospitalization rate.;Timepoint(s) of evaluation of this end point: 60 days from treatment onset
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Death rate related to COVID-19. Related to COVID-19 death is defined as: death caused by respiratory failure, acute respiratory distress syndrome, multiple organ failure, or any other serious complication during the course of an acute SARS-CoV-2 infection.<br>2- Income rate in the Intensive Care Unit.<br>3- Percentage and type of adverse events collected.;Timepoint(s) of evaluation of this end point: 60 days from treatment onset