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Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

NCT ID: NCT04622891

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-07-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Covid19

Keywords

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Azithromycin clarithromycin COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

clarithomycin group Azithromycin group control group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double-blinded

Study Groups

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clarithromycin

clarithromycin group

Group Type EXPERIMENTAL

Clarithromycin 500mg

Intervention Type DRUG

clarithromycin 500

Azithromycin

azithromycin group

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

azithromycin group

control

control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

control group

Interventions

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Clarithromycin 500mg

clarithromycin 500

Intervention Type DRUG

Azithromycin

azithromycin group

Intervention Type DRUG

Placebo

control group

Intervention Type DRUG

Other Intervention Names

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active active comparison control group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Rashad

Associate professor of chest diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa Rashad, MD

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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south-Vally University faculty of medicine

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 34381155 (View on PubMed)

Other Identifiers

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SVU-MED-CHT019-420860

Identifier Type: -

Identifier Source: org_study_id