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

Minoo Mohraz; Mohammadreza Salehi; Hamid Reza  Khorram Khorshid; Nasser Aghdami; Farhad Gharibdoost; Alireza  Barzegary; Zahra Pashaei; SeyedAhmad  SeyedAlinaghi

doi:10.18502/jimc.v6i2.12243

Minoo Mohraz Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran
Mohammadreza Salehi Research center for antibiotic stewardship and antimicrobial resistance, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
Hamid Reza Khorram Khorshid Genetics Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran
Nasser Aghdami Haematology, Oncology and BMT Research Centre, Tehran University of Medical Sciences, Tehran, Iran
Farhad Gharibdoost Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran
Alireza Barzegary Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran
Zahra Pashaei Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran
SeyedAhmad SeyedAlinaghi Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/jimc.v6i2.12243

Keywords: Clinical trial, COVID-19, ICU, NIV, Laboratory profile, SeptimebTM

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.