Trial IRCT20200504047298N1
Publication Siami Z, Iran Red Crescent Med J (2022) (published paper)
Dates: 2020-06-14 to 2020-06-30
Funding: Public/non profit (Alborz University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): 40
Inclusion criteria
  • Hospitalized adults aged between 20 and 80 year
  • diagnosed with COVID-19 with high-resolution computed tomography and suspected history and symptoms or positive SARS-CoV-2 RT-PCR test from nasal and pharyngeal swabs
Exclusion criteria
  • Elevated liver enzymes
  • persistent nausea and vomiting
  • altered mental status
Interventions
Treatment
ATZ/r
Atazanavir 300mg/day + Ritonavir 100 mg/day once a day for up to 14 days
Control
Lopinavir-Ritonavir
Lopinavir 200mg/day + Ritonavir 50mg/day twice a day for up to 14 days

Participants
Randomized
participants :
ATZ/r=54
Lopinavir-Ritonavir=49
Characteristics of participants
N= 103
Mean age : NR
64 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
COViD-19 patients clinical progression (need to be intubated, body temperature, heart rate, respiratory rate, cough, dyspnea, ICU admission); COViD-19 patients para-clinical progression (O2 saturation, CBC, inflammatory biomarkers (ESR, CRP))
In the report
All-cause patient mortality during their hospitalization period
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 article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article differed from the primary outcomes in the registry. The trial (n = 103) achieved its target sample size (n = 100).