Trial IRCT20200415047092N1
Publication Sekhavati E, Int J Antimicrob Age (2020) (published paper)
Dates: 2020-04-24 to 2020-05-08
Funding: Public/non profit (Tehran University of Medical Sciences research centre)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran (Islamic Republic of)
Follow-up duration (days): 30
Inclusion criteria
  • 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 dyspnea
  • 2. A typically involvement of lungs observed in HRCT or Spiral CT scanning that can be strongly attributed to a covid-19 pneumonia 3. 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
Interventions
Treatment
Azithromycin
500 mg orally once a day for 5 days
Control
Standard care

Participants
Randomized
participants :
Azithromycin=56
Standard care=55
Characteristics of participants
N= 111
Mean age : NR
51 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Peripheral capillary oxygen saturation (daily during admission), Admission duration; Fever; Need to ICU admission
In the report
Decrease in mortality, duration of hospitalisation and need for intensive care unit (ICU) admission
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published study report, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plane was available. The study achieved its target sample size. Due to cardiac risks associated with the concomitant use of Azithromycin and Hydroxychloroquine, patients with elevated risk for ventricular arrhythmia were excluded from the combined treatment arm, but not from the standard treatment arm. There were some differences between registry and published report in inclusion criteria and outcomes. There is no change from the trial registration in the intervention and control treatments.