Effectiveness of the combined treatment with hydroxycloroquine and azithromycin vs lopinavir/ritonavir + hydroxycloroquine in hospitalized patients with confirmed COVID-19 infectio
- Conditions
- Covid-19 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001605-23-ES
- Lead Sponsor
- Basque Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
- RT-PCR confirmed.
- 18-80 years.
- Pneumonia confirmed by Rx chest: pneumonia CURB<=1 y Sat O2>92%
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68
->7 days from the onset of symptoms
- Severe disease Covid 19, defined by any of the following: FR<30 per min, sat O2 breathing ambient air<92%, sepsis or septic shock
- Pregnancy
- Kidney or liver terminal disease
- History of allergy to hydroxycloroquine and/or azithromycin
- Patients presenting contraindications to study drugs
- Hyprsensitivity to azithromycin, erythromycin, to any other macrolide or ketolide antibioticor any of the following excipients: pregelatinized corn starch, sodium crocarmellose, sodium laurel sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), triacetin.
- Electrocardiographic abnormalities: treatment is not started or discontinued if QTc (Brazett formula)>500ms and risk-benefit is valued between a460-500 ms. Does not start treatment if ECG shows changes in channel-patties and risk-benefit is valued if there are other abnormalities.
- Patients with glucose 6 phosphate dehydrogenase deficiency.
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