Azithromycin in Hospitalized COVID-19 Patients

NCT04359316 | Unknown Phase 4 DMC

• 1 other identifier: Azithromycin in COVID-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Novel Coronavirus; Hydroxychloroquine; Chloroquine; Azithromycin

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.

  From date of randomization until 14 days later.

Secondary Outcomes (5)

• Mortality

  From date of randomization until 14 days later.

• SpO2 Improvement

  Days 1, 2, 3, 4, 5, 6, 7 and 14.

• Incidence of new mechanical ventilation use

  From date of randomization until 14 days later.

• Duration of hospitalization

  From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.

• Cumulative incidence of serious adverse events

  Days 1, 2, 3, 4, 5, 6, 7 and 14.

Study Arms (2)

Azithromycin

EXPERIMENTAL

Drug: Hydroxychloroquine; Drug: Azithromycin

Hydroxychloroquine

ACTIVE COMPARATOR

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

This Drug will be used in all arms as mandated by our governmental guidelines.

Azithromycin; Hydroxychloroquine

Azithromycin DRUG

This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Azithromycin in COVID-19 patients.

Azithromycin

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
• Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.
• Time of onset of the symptoms should be acute ( Days ≤ 10).
• SpO2 ≤ 93%
• Respiratory Rate ≥ 22

You may not qualify if:

• Refusal to participate expressed by patient or legally authorized representative if they are present.
• Patients with prolonged QT or PR intervals, Second or Third Degree heart block and Arrhythmias.
• Patients using drugs with potential interaction with Azithromycin or Hydroxychloroquine.
• Pregnant or lactating women.
• History of alcohol or drug addiction in the past 5 years.
• Blood ALT/AST levels \> 5 times the upper limit of normal on laboratory results.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences and Health Services

Tehran, Iran

Location

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 Officials

• Mohammad Fathi, MD

  Shahid Beheshti University of Medical Sciences

  STUDY CHAIR

• Sasan Tavana, MD

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

• Nasser Malekpour Alamdari, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mehran Lack, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Nader Markazi, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Sanaz Zargar Balaye Jam, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Seyed Sina Naghibi Irvani, MD, MPH, MBA

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyed Sina Naghibi Irvani, MD, MPH, MBA

CONTACT

09141182825; sina.irvani@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: April 20, 2020
• Primary Completion: May 3, 2020
• Study Completion: May 5, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

IR (1)