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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04622891
Other study ID # SVU-MED-CHT019-420860
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date July 30, 2020

Study information

Verified date November 2020
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Clarithromycin 500mg
clarithromycin 500
Azithromycin
azithromycin group
Placebo
control group

Locations

Country Name City State
Egypt south-Vally University faculty of medicine Qena

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to fever control time to complete resolution of fever 15 days
Secondary PCR conversion time to PCR conversion from first positive PCR for COVID-19 to negative PCR 15 days
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