Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19

NCT04964583 | Unknown Phase 2 DMC

• 1 other identifier: 2020-785-138
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

Chloroquine and hydroxychloroquine are two antimalarial drugs that are also used in autoimmune diseases. Chloroquine analogs have been shown to inhibit endosome acidification and exhibit nonspecific antiviral activity at high micromolar concentration in vitro against a wide range of emerging viruses (HIV, dengue, hepatitis C, chikungunya, influenza, Ebola, SARS, and MERS ). virus) and more recently COVID-19. On the other hand, azithromycin is a macrolide antibiotic indicated for infections caused by sensitive pathogens, but which in combination with Hydroxychloroquine has shown a synergistic effect against the SARS-CoV-2 virus. International studies show the lack of beneficial effect in hospitalized or mechanically ventilated patients. Referring that because these medications reduce the in case of having a beneficial effect it would be in the early onset, to avoid inflammation (cytokine storm), and thus prevent hospitalizations. The present study focuses on characterizing the possible synergy of the fixed combination of hydroxychloroquine associated with azithromycin in the treatment of Covid-19 from mild to moderate manifestations. Three treatment schemes are proposed with a 10-day follow-up, a) the fixed combination of Hydroxychloroquine / Azithromycin (combination of interest), b) Hydroxychloroquine (active comparison group) and c) non-active control group, using placebo. A group of patients between 18 and 75 years old is considered, who may or may not present other comorbidities. Follow-up will be carried out through quantification of viral load, evaluation of the systemic inflammatory state, changes in clinical manifestations and possible effect on the reduction of hospitalizations. Therefore, it is proposed to carry out the following project. objective To determine the efficacy and safety of Hydroxychloroquine / Azithromycin fixed combination compared to Hydroxychloroquine or placebo in outpatients with Research design: Phase II, multicenter, prospective, randomized, parallel, longitudinal, double-blind study. Medications to use Group 1. Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days. Group 2. Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days. Group 3. Placebo one tablet every 12 hours for ten days.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Hospitalization

  Being admitted for hospitalization

  15 days

Secondary Outcomes (2)

• Viral load

  0 and 14 days

• Clinical safety

  21 days

Study Arms (3)

Hydroxychloroquine with Azithromycin

EXPERIMENTAL

Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.

Drug: Hydroxychloroquine with Azithromycin

Hydroxychloroquine

ACTIVE COMPARATOR

Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days.

Drug: Hydroxychloroquine with Azithromycin

Placebo

PLACEBO COMPARATOR

Placebo one tablet every 12 hours for ten days.

Drug: Hydroxychloroquine with Azithromycin

Interventions

Hydroxychloroquine with Azithromycin DRUG

Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.

Also known as: Azithromycin

Hydroxychloroquine; Hydroxychloroquine with Azithromycin; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given the signed informed consent form.
• Confirmed diagnosis of COVID-19 infection by PCR with mild symptoms.
• Patients who attend the primary care respiratory care module in the participating units and who have symptoms suggestive of COVID-19, who comply with the current operational definition.
• With or without comorbidities such as hypertension, controlled diabetes mellitus, cardiovascular or respiratory diseases.
• Controlled diabetes will be considered to be that which is evidenced by results of glycosylated hemoglobin less than 7% in the last 3 tables, whether it is reported in your beneficiary file or by external laboratory results.
• Electrocardiogram (ECG) normal or with variations without clinical relevance, with QT interval \<450 ms.
• No contraindication to study drugs (history of hypersensitivity to study drugs, including macrolides, patients with renal failure (eGFR \<40 mL / min) or on renal replacement therapy, patients with a history of retinopathy or macular degeneration.

You may not qualify if:

• Patients who are participating in studies with investigational drugs.
• Pregnancy or breastfeeding.
• Type 1 diabetes
• % Type II diabetes mellitus with glycated hemoglobin greater than 7%.
• Patients requiring hospitalization or assisted mechanical ventilation
• Cardiac disorders with cardiac conduction delay (QT segment ≥ 450 ms

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Ultra Laboratorios SA. de CV.: collaborator

Study Sites (3)

UMF 28

Benito Juárez, Mexico City, 03100, Mexico

RECRUITING

Fundación IMSS

Cuauhtémoc, Mexico City, 06600, Mexico

NOT YET RECRUITING

UMF 52

Cuautitlán Izcalli, State of Mexico, 54720, Mexico

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 16, 2021
• Study Start: January 20, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months

Locations

ME (3)