Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial.

Type 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNß compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNß1a and IFNß1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNß1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNß1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400 mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNß1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI 1.10-5.17, P-value = 0.031) while the IFNß1b indicated no significant difference compared with the control; HR; 1.42, (95% CI 0.63-3.16, P-value = 0.395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNß1a group and 30% in the IFNß1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNß1a arm. This finding needs further confirmation in larger studies.Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768).

Clinical and Epidemiological Characteristics of Coronavirus Disease 2019 in Iran: a Hospital-Based Observational Study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has been pandemic and has caused a great burden on almost all countries across the world. Different perspectives of this novel disease are poorly understood. This study sought to investigate the clinical and epidemiological characteristics of COVID-19 to efficiently assist the health system of Iran to conquer the outbreak. MATERIALS AND METHODS: This retrospective observational study was performed on 394 patients with a diagnosis of COVID-19. The patients should have a history of hospitalization at Loghman-Hakim hospital, Tehran, Iran, for 10 weeks, beginning from the first official report of the disease in Iran. In the subsequent step, the baseline demographic and clinical and paraclinical information of the patients was documented. Finally, the patients were assessed if they had exhibited any morbidity or mortality. RESULTS: The epidemiological examination of the COVID-19 population suggested a bell diagram pattern for the hospitalization rate, in which the 4th week of the study was the peak. The highest rate of secondary adverse events due to the virus was observed at the 6th and 7th weeks of the study course. On another note, clinical evaluations resulted in identifying specific abnormalities, such as bilateral opacity in chest computed tomography scans or low oxygen saturation in laboratory data. CONCLUSION: This study provides evidence concerning the clinical and epidemiological characteristics of COVID-19 in the first phase of the virus outbreak in Iran. Further studies comparing the disease features in the subsequent phases with findings of this study can pave the way for additional information in this regard.