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 Definition of Standard care: Oral LPV/r 400/100 mg twice daily and oral HCQ 400 mg daily; for both treatment groups, all medi- cations were administered for 5 days. Duration : 5 days | |
Participants | |
Randomized 111 participants (n1=56 / n2= 55) | |
Characteristics of participants N=111 Mean age : 57.1 51 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
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 stated Yes |
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. |