Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19

Maimónides Biomedical Research Institute of Córdoba132 enrolled

Overview

Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.

In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines. To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Acute Respiratory Distress Syndrome Covid19

Interventions

Hydroxychloroquine Pill + Azithromycin PillDRUG

Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0

SOCDRUG

Acetaminophen or Metamizole. Antitussives if needed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell). * Signed informed consent Exclusion Criteria: * Retinal degeneration. * Congenital or acquired long QT syndrome. * Advanced liver failure. * Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute). * Allergic to hydroxychloroquine or azithromycin. * Serious interaction with the drugs used. * Pregnant or breastfeeding. * Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method. * Inability to follow study procedures.

Locations (1)

Centro de Salud Priego de Córdoba

Priego de Córdoba, Córdoba, Spain

RECRUITING

Outcomes

Primary Outcomes

Hospitalization

Time frame: From randomization until patient's hospitalization happens, assessed up to 28 days.

ICU admission

Time frame: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.

Death

Time frame: From randomization until death by any cause related to COVID19, assessed up to 28 days.

Secondary Outcomes

Clinical Evolution

Clinical evolution will be evaluated through the following symptoms: fever, cough, dyspnoea, diarrhea, loss of smell.

Time frame: From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.

Central Contacts

Antonio Miguel Luque Pineda

CONTACT

+34 671 596 070 uicec@imibic.org

Data from ClinicalTrials.gov

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