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Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04622891
Recruitment Status : Completed
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Rashad, South Valley University

Study Description
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Brief Summary:
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough

Condition or disease Intervention/treatment Phase
Covid19 Drug: Clarithromycin 500mg Drug: Azithromycin Drug: Placebo Not Applicable

Detailed Description:

The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough.

All study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or GIT symptoms, C-reactive protein (CRP), serum ferritin, D-dimer, Complete blood count (CBC), non-contrast chest computed tomography (CT) which was repeated 2 weeks after the start of treatment.

The Azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the Clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: clarithomycin group Azithromycin group control group
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double-blinded
Primary Purpose: Treatment
Official Title: Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: clarithromycin
clarithromycin group
 Drug: Clarithromycin 500mg
clarithromycin 500
Other Name: active
Active Comparator: Azithromycin
azithromycin group
 Drug: Azithromycin
azithromycin group
Other Name: active comparison
Placebo Comparator: control
control group
 Drug: Placebo
control group
Other Name: control group


Outcome Measures
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Primary Outcome Measures :
  1. time to fever control [ Time Frame: 15 days ]
    time to complete resolution of fever


Secondary Outcome Measures :
  1. PCR conversion [ Time Frame: 15 days ]
    time to PCR conversion from first positive PCR for COVID-19 to negative PCR


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 cases
  • Oxygen saturation > 93%
  • Age >18 years

Exclusion Criteria:

  • Patients <18 years,
  • patients with Oxygen saturation < 93%, patients with
  • Diabetes mellitus or
  • heart failure,
  • patients on chemotherapy or immunosuppressive therapy
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): NCT04622891


Locations
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Egypt
south-Vally University faculty of medicine
Qena, Egypt, 868532
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: Alaa Rashad, MD associate professor
More Information
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Responsible Party: Alaa Rashad, Associate professor of chest diseases, South Valley University
ClinicalTrials.gov Identifier: NCT04622891    
Other Study ID Numbers: SVU-MED-CHT019-420860
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Rashad, South Valley University:
Azithromycin
clarithromycin
COVID-19
Additional relevant MeSH terms:
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Infection
Azithromycin
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors