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

July 7, 2021 updated by: Maimónides Biomedical Research Institute of Córdoba

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antonio Miguel Luque Pineda
  • Phone Number: +34 671 596 070
  • Email: uicec@imibic.org

Study Locations

  • Spain
    • Córdoba
      • Priego de Córdoba, Córdoba, Spain, 14800
        • Recruiting
        • Centro de Salud Priego de Córdoba
        • Contact:
          • Jesús Gallardo de Ávila, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxychloroquine + Azithromycin

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

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
Active Comparator: SOC (Standard of Care)

SOC for symptoms treatment

Acetaminophen or Metamizole, 1-1-1 Antitussives if needed
Drug: SOC
Acetaminophen or Metamizole. Antitussives if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalization
Time Frame: From randomization until patient's hospitalization happens, assessed up to 28 days.
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.
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMBUCOV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared after the study concludes and results are published

IPD Sharing Time Frame

When study is published.

IPD Sharing Access Criteria

Sending request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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