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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04964583
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
Ultra Laboratorios SA. de CV.
Information provided by (Responsible Party):
Rodolfo Rivas Ruiz, Coordinación de Investigación en Salud, Mexico

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Hydroxychloroquine with Azithromycin Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Prospective, Parallel Study to Demonstrate the Efficacy and Safety of Outpatient Treatment of the Fixed Combination of Hydroxychloroquine With Azithromycin Versus Hydroxychloroquine Treatment and Placebo Treatment in Patients Diagnosed With Mild COVID-19 Infection
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxychloroquine with Azithromycin
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
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.
Other Name: Azithromycin
Active Comparator: Hydroxychloroquine
Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days.
 Drug: Hydroxychloroquine with Azithromycin
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.
Other Name: Azithromycin
Placebo Comparator: Placebo
Placebo one tablet every 12 hours for ten days.
 Drug: Hydroxychloroquine with Azithromycin
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.
Other Name: Azithromycin


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization [ Time Frame: 15 days ]
    Being admitted for hospitalization


Secondary Outcome Measures :
  1. Viral load [ Time Frame: 0 and 14 days ]
    Measured by RT-PCR

  2. Clinical safety [ Time Frame: 21 days ]
    any adverse event


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964583


Locations
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Mexico
UMF 28 Recruiting
Benito Juárez, Mexico City, Mexico, 03100
Contact: Ivonne A Roy, MD    525522704760    ivonne3316@gmail.com   
Sub-Investigator: Magaly A Ortiz Zamora, MD         
Sub-Investigator: Lourdes G Navarro Susano, MD         
Principal Investigator: Ivonne A Roy García, MD         
Fundación IMSS Not yet recruiting
Cuauhtémoc, Mexico City, Mexico, 06600
Contact: Martha M Zapata Tarrés, MD    5554184099      
Sub-Investigator: Marta M Zapata Tarrés, MD         
Principal Investigator: Pedro Gutierrez Castrellón, MD         
Sub-Investigator: Romeo Rodríguez Suárez, MD         
UMF 52 Recruiting
Cuautitlán Izcalli, State Of Mexico, Mexico, 54720
Contact: Moises Moreno, MD    5565593877    sesby14@gmail.com   
Sub-Investigator: Miroslava Guzmán Rivas, MD         
Principal Investigator: Moises Moreno Noguez, MD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Ultra Laboratorios SA. de CV.
More Information
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Responsible Party: Rodolfo Rivas Ruiz, MD, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04964583    
Other Study ID Numbers: 2020-785-138
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Database with all non identifiable data will be available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents