Publication Sadeghi A, J Antimicrob Chemother, 2020
Dates: 2020-03-26 to 2020-04-26
Funding: Mixed (Fanavaran Rojan Mohaghegh Daru Co.; Digestive Disease Research Institute of Tehran University of Medical Sciences)
Multicenter / Iran |
Follow-up duration (days): 30
|Inclusion criteria||All adult patients aged at least 18 years admitted with suspected COVID-19 infection between 26 March and 26 April 2020 were evaluated for eligibility. Participants were enrolled into the study if they had both positive qualitative RT–PCR on nasopharyngeal swab and chest CT scan compatible with moderate or severe COVID-19 infection. In addition, participants were required to have signs of severity of disease defined as fever (oral temperature ≥37.8C at any one time prior to enrolment) and at least one of respiratory rate >24/min, O2 saturation <94% or PaO2/FiO2 ratio <300 mgHg. Only participants whose onset of symptoms was 8 days or less were included. All patients were required to provide written informed consent prior to participation in the study.|
|Exclusion criteria||A known allergic reaction to the intervention drugs, pregnant or breastfeeding, any prior experimental treatment for COVID-19, heart rate <60 bpm, taking amiodarone, evidence of multiorgan failure, requiring invasive mechanical ventilation at screening and estimated glomerular filtration rate (eGFR) <50mL/1.73 m2/min.|
Co-Intervention: Standard care
Duration : 14 days
Definition of Standard care: National IranianCOVID-19 treatment guidelines which at the time of the study washydroxychloroquine 200mg twice daily with or without lopinavir/ritonavir200mg/50mg twice daily.
70 participants (n1=35 / n2= 35)
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0
|In the register|
Clinical recovery (composite) within 14 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤ 24/minute on room air), and oxygen saturation (≥ 94% on room air), sustained for at least 24 hours.
|In the report|
Clinical recovery within 14 days of enrolment.
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to all available versions of the published article, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved. There is no change from the trial registration in the intervention and control treatments or in the primary and secondary outcomes.|