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Inflawell® improves neutrophil-to-lymphocyte ratio and shortens hospitalization in patients with moderate COVID-19, in a randomized double-blind placebo-controlled clinical trial.
Barzin Tond, Sepideh; Balenci, Laurent; Khajavirad, Nasim; Salehi, Mohammadreza; Tafakhori, Abbas; Shahmohammadi, Mohammad Reza; Ghiasvand, Fereshteh; Jafari, Sirous; Abolghasemi, Sara; Mokhtari, Farzad; Mahmoodi Baram, Somayyeh; Zarei, Tayebe; Kazemi, Davood; Mohammadnejad, Esmaeil; Shah-Hosseini, Akram; Haghbin Toutounchi, Alireza; Fallah, Soudabeh; Riazi, Ali; Karima, Saeed.
  • Barzin Tond S; Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.
  • Balenci L; Kondor Pharma Inc, Toronto, Canada.
  • Khajavirad N; Internal Medicine Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Salehi M; Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Tafakhori A; Department of Neurology, School of Medicine, Iranian Center of Neurological Research, Neuroscience Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Shahmohammadi MR; Functional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.
  • Ghiasvand F; Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Jafari S; Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Abolghasemi S; Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medial Sciences (SBMU), Tehran, Iran.
  • Mokhtari F; Kondor Pharma Inc, Toronto, Canada.
  • Mahmoodi Baram S; Kondor Pharma Inc, Toronto, Canada.
  • Zarei T; Clinical Trial Department, Behbalin Inc, Tehran, Iran.
  • Kazemi D; Clinical Trial Department, Behbalin Inc, Tehran, Iran.
  • Mohammadnejad E; Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Shah-Hosseini A; Department of Medical-Surgical Nursing and Basic Sciences, School of Nursing & Midwifery, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
  • Haghbin Toutounchi A; Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.
  • Fallah S; Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.
  • Riazi A; Department of Biochemistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
  • Karima S; Kondor Pharma Inc, Toronto, Canada.
Inflammopharmacology ; 30(2): 465-475, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1708824
ABSTRACT

AIMS:

COVID-19 is a significant global threat to public health. Despite the availability of vaccines and anti-viral drugs, there is an urgent need for alternative treatments to help prevent and/or manage COVID-19 symptoms and the underlying dysregulated immune response. We hypothesized that administration of Inflawell® syrup, a Boswellia extract formulation enriched for boswellic acids (BAs), can reduce the excessive or persistent inflammation and thereby prevent disease progression. BAs are medicinally activated triterpenoids found in the resins of Boswellia spp., and possess an immense therapeutic potential due to their anti-inflammatory and immunoregulatory activities. We investigated the effect of Inflawell® syrup, on moderate COVID-19 patients along with the current standard of care treatment.

METHODS:

A randomized placebo-controlled double-blind clinical trial was conducted, following definitive confirmation of COVID-19. Forty-seven hospitalized patients with moderate COVID-19 were enrolled and received either the Inflawell® syrup or placebo. Clinical symptoms and markers of inflammation were evaluated at baseline and completion of the trial.

RESULTS:

Our clinical trial revealed an increase in the percentage of oxygen saturation level in patients that received the BAs compared to placebo (P < 0.0001). In addition, the average duration of hospitalization was significantly shorter in the BAs group compared with the placebo group (P < 0.04). Concomitantly, some improvement in the clinical symptoms including cough, dyspnea, myalgia, headache, and olfactory and gustatory dysfunction were detected in the BAs group. Hematologic findings showed a significant decrease in the percentage of neutrophils (P < 0.006) and neutrophil-to-lymphocyte ratio (NLR) levels (P < 0.003), associated with a significant increase in the percentage of lymphocytes in the BAs group compared with the placebo (P < 0.002). Additionally, a significant decrease in CRP, LDH, IL - 6 and TNF - α levels was detected in the BAs group. Following the intervention, fewer patients in the BAs group were PCR-positive for COVID-19 compared to placebo, though not statistically significant.

CONCLUSION:

Overall, the treatment with Inflawell® resulted in shorter hospital stay, alleviation of COVID-19 clinical symptoms and decline in the level of pro-inflammatory cytokines. TRIAL REGISTRATION The trial has been registered in  https//www.irct.ir  with unique identifier IRCT20170315033086N10 ( https//en.irct.ir/trial/51631 ). IRCT is a primary registry in the WHO registry network ( https//www.who.int/clinical-trials-registry-platform/network/primary-registries ).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment / Neutrophils Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Long Covid / Vaccines Limits: Humans Language: English Journal: Inflammopharmacology Journal subject: Pharmacology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: S10787-022-00928-w

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment / Neutrophils Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Long Covid / Vaccines Limits: Humans Language: English Journal: Inflammopharmacology Journal subject: Pharmacology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: S10787-022-00928-w