Placebo-controlled clinical trial to evaluate the efficacy and safety of hydroxychloroquine and azithromycin in relation to placebo in the negative viral load of participants with SARS-CoV2 flu syndrome and who do not have an indication for hospitalizatio
- Conditions
- SARS Cov2 virus infectionB97.2
- Registration Number
- RBR-95yjmq
- Lead Sponsor
- Hospital Santa Paula
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion criteria
Age 18 and 65 years;
Flu syndrome for 48-120 hours characterized by the presence of at least two of the following: fever (may be absent), fatigue, cough (dry or productive), anorexia, malaise, muscle pain, sore throat, dyspnea, congestion nasal, anosmia, headache, diarrhea, nausea and vomiting. If the patient has pneumonia without signs of severity and without the need for supplemental oxygen, he will be eligible;
Infection with the SARS-CoV2 virus (COVID19), confirmed by a qualitative molecular test on nasopharyngeal and oropharyngeal swab samples;
Patients with no clinical indication for hospitalization;
Consent, voluntarily, to participate in the study by signing the Informed Consent Form (ICF).
Exclusion criteria
History of allergy or hypersensitivity to hydroxychloroquine, azithromycin, or any other component of the study drugs;
Any other condition that contraindicates the use of hydroxychloroquine, including ocular retinopathy, G6PD deficiency, prolonged QTc;
History of any lung disease including, but not limited to: chronic obstructive pulmonary disease (COPD), asthma, structural lung diseases; pulmonary fibrosis;
Immunosuppressed patients, whether due to pre-existing diseases or through the use of immunosuppressive treatment;
Patients with any malignancy;
History of any neurological event, including seizure, stroke, TIA and others;
History of cardiopathies or cardiovascular diseases, including severe arterial hypertension (defined by systolic pressure 160mmHg and / or diastolic pressure 100mgHg), atrial fibrillation, AMI, VTE, cardiac arrhythmias and others;
Prolonged Qt interval (Qtc greater than 480ms), evidenced by the ECG at the time of inclusion in the study;
Altered values ??of creatine phosphokinase (CPK): 5x above LSN
Altered values ??for lactic dehydrogenase (LDH): greater than 1000U / L
Insulin dependent diabetic patients;
Patients with renal failure defined by creatinine clearance less than 50mL / min calculated by the Cockcroft-Gault formula
Patients with significant hematological changes, defined by: anemia (hemoglobin less than 10g / dL), thrombocytopenia (platelets less than 100,000 / mm3), or leukopenia (leukocytes less than 2,000 / mm3)
Patients with TGO or TGP values ??2.5x above ULN or altered prothrombin time (INR above 1.5);
Patients with lower D-dimer3g / L at the time of inclusion in the study;
Patients already using hydroxychloroquine and its derivatives and / or azithromycin at the time of inclusion in the study;
Patients using antiretrovirals;
Patients participating in any clinical study, in the last 6 months until the moment of inclusion in the study;
Pregnant or breastfeeding women. For all women of childbearing potential who are able to become pregnant, a quantitative test will be performed at the screening visit to evaluate hCG in a blood sample to rule out pregnancy.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method