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 hospitalization

INTERVENTION: Administration, Oral Azithromycin Drug Hydroxychloroquine 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 consecutive days. Chloroquine and Azithromycin should be started on the same day and the first dose of medications should be administered at the center under the supervision of the pharmacist. The participant who is allocated to the control group will receive a non‐active placebo and both groups will be instructed on symptomatic treatment. The participant will be reassessed on days D3, D6, D9 and between D14 and D21, with medical evaluations performed by telemedicine. Additionally, on days D3, D6, and D9, a qualified professional will go to the participant s home to collect nasopharyngeal and oropharyngeal swab samples for the quantification of viral load by qRT‐PCR, and an ECG. Between days D14 and D21, the participant must return to the center to perform a chest CT scan without contrast to assess the radiographic response. The last consultation by telemedicine will be carried out to evaluate and present the results of the CT scan. Additional blood samples will be collected at screening and at D3, D6, and D9 for storage in a biorepository for future analysis of the serum level, genetic and metabolic profiles that may be associated with the response to treatment. CONDITION: A00‐B99 Coronavirus as the cause of diseases classified to other chapters SARS Cov2 virus infection ; Coronavirus as the cause of diseases classified to other chapters PRIMARY OUTCOME: 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 OUTCOME: 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 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 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 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; 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).