The effect of azithromycin in treatment of COVID19

• Register: IRCT
• Last refreshed on: 18 May 2020
• Main ID: IRCT20200415047092N1
• Date of registration: 2020-04-20
• Prospective Registration: Yes
• Primary sponsor: Tehran University of Medical Sciences
• Public title: The effect of azithromycin in treatment of COVID19
• Scientific title: Safety and Effectiveness of azithromycin in Patients with COVID-19 Referred to zeiaeian Hospital : A clinical trial study
• Date of first enrolment: 2020-04-24
• Target sample size: 110
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/47244
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients use randomized block-chain, which not only makes Randomization equal in two groups, but also allows patients to be assigned equally to both groups at each stage of the study. These small blocks keep the balance between the two groups and make the number of people in each group similar. In our study, considering that there are two groups, four patients are considered for each block.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Fereshte Ghiasvand
• Affiliation: Tehran University of Medical Sciences

• Name: Ehsan Sekhavati Moghadam
• Affiliation: Tehran University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: - Obtaining informed consent from patient or patient’s legal proxy for inclusion in this study.-
Patients must be over 18 years of age-
A documented positive PCR test for SARS-CoV-2 or one of the following criteria:1. Compelling clinical symptoms associated with a covid-19 infection; including: fever, dry cough and dyspnea2. A typically involvement of lungs observed in HRCT or Spiral CT scanning that can be strongly attributed to a covid-19 pneumonia3.
Patients that have developed known complications of a covid-19 infection such as acute respiratory distress syndrome (ARDS) or myocarditis.
Exclusion criteria: pregnancy or nursing
Patients whose covid-10 infection has not been proven and have symptoms that can be attributed to either the common cold or influenza and/or have had a positive PCR test for influenza.
known allergy to chloroquine or hydroxylchloroquine
retinopathy
G6PD deficiency
prolonged QT interval
severe heart failure
Pacemaker implantation
cardiac arrhythmia

Age minimum: 18 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

SARS-COV2 ASSOCIATED INFECTION.
COVID-19, virus identified

U07.1

Intervention(s)

Intervention 1: Intervention group: These patients receive daily azithromycin 500 mg, bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or in case of adverse gastrointestinal effects daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all for 5 days. Intervention 2: Control group: These patients receive bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or atazanavir (Kaletra) 400/100 mg and in case of adverse gasterointestinal effects, daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all drugs are administered for five days.

Primary Outcome(s)

Fever. Timepoint: At the beginning of the visit and daily during admission. Method of measurement: Mercury thermometer.

Need to ICU admission. Timepoint: During admission. Method of measurement: Questionnaire.

Admission duration. Timepoint: From the beginning of the hospital visit to the discharge. Method of measurement: Questionnaire.

Peripheral capillary oxygen saturation. Timepoint: At the beginning of the visit and daily during admission. Method of measurement: pulse oximeter.

Source(s) of Monetary Support

Tehran University of Medical Sciences

Ethics review

Status: Approved
Approval date: 08/04/2020
Contact:

Ethics committee of Tehran University of Medical Sciences