Trial IRCT20200318046812N2
Publication - Ghanei M, 2021 (published paper)
Dates: 4/13/2020 to 8/9/2020
Funding: Public/non profit (Bagheiat-allah University of Medical Sciences, Iran University of Medical Sciences)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Iran Follow-up duration (days): 28 | |
Inclusion criteria | 1) Hospitalized; 2)16 years of age or older; 3) positive polymerase-chain-reaction (PCR) assay; 4) oxygen saturation (Spo2) less than 94%. |
Exclusion criteria | 1)history of receiving any medications (i.e., Immunosuppressive drugs, systemic steroids, chemotherapy drugs, Hydroxychloroquine, Lopinavir/Ritonavir, Ribavirin, and Oseltamivir) for COVID-19 in the last month; 2)uncontrolled diabetes; 3)asthma; 4) chronic renal or liver disease; 5)gastrointestinal hemorrhage; 6)untreated bacterial infection; 7)pregnancy or breast-feeding; 8)QT intervalââ¥â500 ms. 9)COVID-19 patients who were ill with less than 48 h. |
Interventions | |
Treatment 1 Prednisolone+Azithromycin+Naproxen | |
Control Lopinavir+Ritonavir | |
Treatment 3 Azithromycin+Naproxen | |
Participants | |
Randomized 352 participants n1=120/ n2=116/ n3=116 | |
Characteristics of participants N=352 Mean age : 58.07 173 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=352 Critical: n=0 | |
Primary outcome | |
In the register Admission to intensive care unit | |
In the report Regarding differences in the prognosis of patients, subgroup analysis was performed depending on the presence of comorbidity, age, and sex. | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
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 study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. There were some differences in secondary outcomes between the registry and the article. The study (n = 352) did not achieve its target sample size (n = 906) because it was stopped on the decision of the scientific committee as the use of corticosteroids even at doses than this study was added to the protocol of Iran for patients with COVID-19. |