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

Phase 2

• Conditions: Acute Respiratory Distress Syndrome; Covid19
• Interventions: Drug: SOC; Drug: Hydroxychloroquine Pill + Azithromycin Pill

• Registration Number: NCT04954040
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

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

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 Timeline

• Study Start: 2021-02-10
• Status Verified: 2021-04
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOC (Standard of Care)	SOC	SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed
Hydroxychloroquine + Azithromycin	Hydroxychloroquine Pill + Azithromycin Pill	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.

Primary Outcome Measures

Name	Time	Method
Death	From randomization until death by any cause related to COVID19, assessed up to 28 days.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro de Salud Priego de Córdoba; 🇪🇸 Priego de Córdoba, Córdoba, Spain