SARS Cov2 virus infection
Conditions
Interventions
The participant who is allocated to the intervention group must take Chloroquine 400mg twice a day for 7 consecutive days and Azithromycin 500mg once a day followed by Azithromycin 250mg 1x day for 5
Drug
Sponsors
Hospital Santa Paula
Hospital Santa Paula
Diagnósticos da América S/A
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the primary outcome of the study, the time to negative viral load from the beginning of treatment and up to 9 days will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will assess the description of variables, demographic and clinical for the entire study population, they are described as: age, sex, race, co-infection profile, symptoms, duration of symptoms, comorbidities, use of concomitant medications;It is intended to find the reduction in viral load observed on days D0, D3, D6 and D9, which will be measured by the AUC of the viral load values ??(log10 copies per mL), calculated using the Ct values ??(cycle threshold) obtained by qRT-PCR of nasopharyngeal and oropharyngeal swab samples;Time until clinical improvement defined as the time until symptom normalization according to the clinical evaluation carried out by the researcher during the telemedicine consultation; Frequency of using concomitant medication to manage symptoms; Time to clinical failure defined as time until symptoms worsen (according to clinical evaluation), or return to the emergency room;;Radiographic response between 14 and 21 days after the start of treatment. The following responses will be considered: complete remission, partial remission, progression, stable, non-evaluable; Hospitalization rate during the study period Description of adverse events and serious adverse events during the study period | — |
Countries
Brazil
Contacts
Public ContactAna Tarina Lopes
Hospital Santa Paula
Outcome results
None listed