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

NCT04954040 | Unknown Phase 2

• 1 other identifier: AMBUCOV
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Covid19

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Hydroxychloroquine + Azithromycin

EXPERIMENTAL

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

SOC (Standard of Care)

ACTIVE COMPARATOR

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

Drug: SOC

Interventions

Hydroxychloroquine Pill + Azithromycin Pill DRUG

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

Hydroxychloroquine + Azithromycin

SOC DRUG

Acetaminophen or Metamizole. Antitussives if needed.

SOC (Standard of Care)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Centro de Salud Priego de Córdoba

Priego de Córdoba, Córdoba, 14800, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Central Study Contacts

Antonio Miguel Luque Pineda

CONTACT

+34 671 596 070; uicec@imibic.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 8, 2021
• Study Start: February 10, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: When study is published.
• Access Criteria: Sending request.

Locations

ES (1)