Safety and Effectiveness of SeptimebTM in Patients with COVID-19 Referred to a Teaching and Referral Hospital: An Uncontrolled Clinical Trial Study (Phase II)

Abstract

Background: We conducted this study to determine the safety and evidence of effectiveness of SeptimebTM among patients with COVID-19.
 Methods: An uncontrolled phase II clinical trial with SeptimebTM was implemented in Imam Khomeini Hospital as a before-and-after trial during May to October 2020. Considering the inclusion and exclusion criteria, 33 patients with COVID-19 were treated using SeptimebTM. The patients received the anti-inflammatory drug 150 mg /10 ml /IV infusion SeptimebTM on the first day and then 300 mg /20 ml / IV infusion from the second day onwards for at least 2 days and up to 13 days based on the improvement of clinical symptoms and laboratory findings in addition to treatment which were selected according to the national protocol. The patients were then evaluated for the treatment efficacy and side effects. Adherence to treatment, clinical observations, and side effects were recorded before and after the treatment.
 Results: The herbal drug SeptimebTM was injected in phase two of an uncontrolled clinical trial on 33 patients with COVID-19 in Imam Khomeini Hospital in Tehran as a before-and-after trial. The number of new cases admitted to the Intensive Care Unit (ICU) and the new need to Non-Invasive Ventilation (NIV) ecreased compared to before the treatment. Also, blood oxygen saturation and platelet count increased. Conversely, CRP, ESR, and ferritin levels decreased (p<0.05). Besides, SeptimebTM did not show any serious side effects except recurrent thrombophlebitis during the treatment.
 Conclusion: We found some evidence regarding the efficacy of this drug and its low amount of short term side effects. The investigators recommend conducting the third phase of the clinical trial.