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

Author(s):

Minoo Mohraz, Mohammadreza Salehi, Hamid Reza Khorram Khorshid, Nasser Aghdami, Farhad Gharibdoost, Alireza Barzegary, Zahra Pashaei and Seyed Ahmad Seyed Alinaghi*

Objectives: We conducted this study to determine the safety and evidence of effectiveness of Septimeb ^TM among patients with COVID-19.

Materials and methods: A phase II clinical trial with Septimeb^TM 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 Septimeb^TM. The patients received the antiinflammatory drug 150 mg/10m l/IV infusion Septimeb^TM on the irst 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 indings in addition to treatment which were selected according to the national protocol. The patients were then evaluated for the treatment efficacy and sideeff ects. Adherenceto treatment, clinical observations, and side effects were recorded before and after the treatment.

Results: The herbal drug Septimeb^TM was injected in phase two of a 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 NIV decreased compared to before 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 exceptr ecurrent 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.