NCT04622891

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 6, 2020

Last Update Submit

November 7, 2020

Conditions

Keywords

AzithromycinclarithromycinCOVID-19

Outcome Measures

Primary Outcomes (1)

  • time to fever control

    time to complete resolution of fever

    15 days

Secondary Outcomes (1)

  • PCR conversion

    15 days

Study Arms (3)

clarithromycin

EXPERIMENTAL

clarithromycin group

Drug: Clarithromycin 500mg

Azithromycin

ACTIVE COMPARATOR

azithromycin group

Drug: Azithromycin

control

PLACEBO COMPARATOR

control group

Drug: Placebo

Interventions

clarithromycin 500

Also known as: active
clarithromycin

azithromycin group

Also known as: active comparison
Azithromycin

control group

Also known as: control group
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

south-Vally University faculty of medicine

Qina, Qena Governorate, 868532, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Interventions

ClarithromycinExerciseAzithromycinControl Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alaa Rashad, MD

    associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: clarithomycin group Azithromycin group control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of chest diseases

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 10, 2020

Study Start

April 1, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations