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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19

Conditions
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Covid19, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Hydroxychloroquine Pill + Azithromycin Pill
* Drug: SOC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine + Azithromycin<br>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 Oral intake in all cases. Pills will be taken simultaneously. | Drug: Hydroxychloroquine Pill + Azithromycin Pill<br>* 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<br>|
| Active Comparator: SOC (Standard of Care)<br>SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed | Drug: SOC<br>* Acetaminophen or Metamizole. Antitussives if needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | From randomization until patient's hospitalization happens, assessed up to 28 days. | 
| ICU admission |  | From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days. | 
| Death |  | From randomization until death by any cause related to COVID19, assessed up to 28 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evolution | Clinical evolution will be evaluated through the following symptoms: fever, cough, dyspnoea, diarrhea, loss of smell. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, acute respiratory syndrome, SARS-CoV-2, hydroxychloroquine, azithromycin, COVID19 symptoms