Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Clarithromycin 500mg; Drug: Azithromycin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qena, Egypt, 868532
    • south-Vally University faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: clarithromycin; clarithromycin group	Drug: Clarithromycin 500mg; clarithromycin 500; Other Names: active
Active Comparator: Azithromycin; azithromycin group	Drug: Azithromycin; azithromycin group; Other Names: active comparison
Placebo Comparator: control; control group	Drug: Placebo; control group; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to fever control	time to complete resolution of fever	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR conversion	time to PCR conversion from first positive PCR for COVID-19 to negative PCR	15 days

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Principal Investigator: Alaa Rashad, MD, Associate Professor

Publications and helpful links

General Publications

• Rashad A, Nafady A, Hassan MH, Mansour H, Taya U, Bazeed SES, Aref ZF, Sayed MAA, Nafady-Hego H, Abdelmaksoud AA. Therapeutic efficacy of macrolides in management of patients with mild COVID-19. Sci Rep. 2021 Aug 11;11(1):16361. doi: 10.1038/s41598-021-95900-z.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 7, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 7, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Azithromycin; clarithromycin
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin; Azithromycin
• Other Study ID Numbers: SVU-MED-CHT019-420860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No