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

Primary Purpose

Acute Respiratory Distress Syndrome, Covid19

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Hydroxychloroquine Pill + Azithromycin Pill

SOC

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring acute respiratory syndrome, SARS-CoV-2, COVID19, hydroxychloroquine, azithromycin, COVID19 symptoms

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centro de Salud Priego de CórdobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydroxychloroquine + Azithromycin

SOC (Standard of Care)

Arm Description

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.

SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed

Outcomes

Primary Outcome Measures

Hospitalization

ICU admission

Death

Secondary Outcome Measures

Clinical Evolution

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

Full Information

NCT ID

NCT04954040

First Posted

July 6, 2021

Last Updated

July 7, 2021

Sponsor

Maimónides Biomedical Research Institute of Córdoba

1. Study Identification

Unique Protocol Identification Number

NCT04954040

Brief Title

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

Acronym

AMBUCOV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 10, 2021 (Actual)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maimónides Biomedical Research Institute of Córdoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome, Covid19

Keywords

acute respiratory syndrome, SARS-CoV-2, COVID19, hydroxychloroquine, azithromycin, COVID19 symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydroxychloroquine + Azithromycin

Arm Type

Experimental

Arm Description

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.

Arm Title

SOC (Standard of Care)

Arm Type

Active Comparator

Arm Description

SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine Pill + Azithromycin Pill

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SOC

Intervention Description

Acetaminophen or Metamizole. Antitussives if needed.

Primary Outcome Measure Information:

Title

Hospitalization

Time Frame

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

Title

ICU admission

Time Frame

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

Title

Death

Time Frame

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

Secondary Outcome Measure Information:

Title

Clinical Evolution

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antonio Miguel Luque Pineda

Phone

+34 671 596 070

uicec@imibic.org

Facility Information:

Facility Name

Centro de Salud Priego de Córdoba

City

Priego de Córdoba

State/Province

Córdoba

ZIP/Postal Code

14800

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesús Gallardo de Ávila, Doctor

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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