Clinical trial NCT04964583: Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Ultra Laboratorios SA. de CV.
First posted: 2021-07-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Hospitalization
timeFrame: 15 days
Secondary outcomes:
measure: Viral load
timeFrame: 0 and 14 days
measure: Clinical safety
timeFrame: 21 days
Other outcomes:
Locations:
city: Benito Juárez
country: Mexico
facility: UMF 28
state: Mexico City
city: Cuauhtémoc
country: Mexico
facility: Fundación IMSS
state: Mexico City
city: Cuautitlán Izcalli
country: Mexico
facility: UMF 52
state: State Of Mexico
Study officials:
References: