search
Back to results

Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Clarithromycin 500mg
Azithromycin
Placebo
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Azithromycin, clarithromycin, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • south-Vally University faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

clarithromycin

Azithromycin

control

Arm Description

clarithromycin group

azithromycin group

control group

Outcomes

Primary Outcome Measures

time to fever control
time to complete resolution of fever

Secondary Outcome Measures

PCR conversion
time to PCR conversion from first positive PCR for COVID-19 to negative PCR

Full Information

First Posted
November 6, 2020
Last Updated
November 7, 2020
Sponsor
South Valley University
search

1. Study Identification

Unique Protocol Identification Number
NCT04622891
Brief Title
Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection
Official Title
Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Azithromycin, clarithromycin, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clarithomycin group Azithromycin group control group
Masking
ParticipantOutcomes Assessor
Masking Description
double-blinded
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clarithromycin
Arm Type
Experimental
Arm Description
clarithromycin group
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Description
azithromycin group
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
Clarithromycin 500mg
Other Intervention Name(s)
active
Intervention Description
clarithromycin 500
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
active comparison
Intervention Description
azithromycin group
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
control group
Intervention Description
control group
Primary Outcome Measure Information:
Title
time to fever control
Description
time to complete resolution of fever
Time Frame
15 days
Secondary Outcome Measure Information:
Title
PCR conversion
Description
time to PCR conversion from first positive PCR for COVID-19 to negative PCR
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Rashad, MD
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
south-Vally University faculty of medicine
City
Qena
ZIP/Postal Code
868532
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34381155
Citation
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.
Results Reference
derived

Learn more about this trial

Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

We'll reach out to this number within 24 hrs