Evaluation of the effect of inflawell-syrup on the immune response and the signaling pathway of NF-kB in peripheral blood mononuclear cell in patients with COVID-19: Double blind, placebo-controlled randomized clinical trial

Evaluation of the effect of inflawell syrup on the immune response and the signaling pathway of NF-kB in peripheral blood mononuclear cell in patients with COVID-19

Two arm parallel group randomized double-blind placebo-controlled clinical trial

In this study, 40 patients admitted to the infectious ward of Imam Khomeini Hospital due to COVID-19 which confirmed by Polymerase chain reaction test (PCR) , will be evaluated by the researcher based on inclusion and exclusion criteria and will be allocated into the intervention group randomly after completing the consent form.

Inclusion criteria: 1) COVID-19 patient admitted to the infectious ward of the hospital 2) Age ≥ 18 years in both sexes 3) Confirmation of SARS-CoV2 infection based on PCR test and clinical manifestations including: 1. Respiratory distress (breathing ≥ 25 times per minute) 2. Percentage of oxygen saturation at rest ≤92% 4) Early diagnosis (less than or equal to 8 days from the onset of symptoms) 5) Signing the informed consent form Exclusion criteria: 1) Liver, kidney and heart failure 2) Inability of the patient to consume the oral form 3) Pregnancy and lactation or positive pregnancy test 4) Participate in two or more clinical trials simultaneously

Intervention group: Patients will receive standard treatments and inflawell syrup (provided By KondorPharma company, Canada) containing standardized powder of Boswellic acids 3 times a day 10 milliliter each time for 14 days (n = 20). Control group: Patients will receive placebo and standard treatments for 14 days (n = 20).

Primary outcome: Duration of hospital stay Secondary outcome: Measurement of C-Reactive Protein (CRP) levels in plasma

virawell change to inflawell

Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the intervention, the patient-assigned code (patient code) and the order of recruitment (referral code) is generated by Stata v.15. In each four-sized block there are two drugs and two placebo intervention. There are also six modes for four-sized block layout which used by software in order to randomization. In addition to the intervention type , the computer list also includes two sets of number. one of them is related to the order of referral sequence or recruitment, which starts from the number one and goes in order. The other set is related to the patient code, which consists of non-consecutive and irregular three-digit numbers, and thus the type of intervention can not be guessed from the order in which patients enter the study. For example, the first person has a three-digit number as a special code. In order to do randomization and concealment, the patient codes are placed inside the concealed envelopes, the sequence of patient referral is written on envelopes. The patient code is also written on the medicine bottle (drug or placebo). In this way, following screening patients based on the inclusion and exclusion criteria and obtaining informed consent, according to the order of referral, the relevant envelope is opened and assigned code is given to the patient and then a bottle with the same code is given to the patient. Thus, the process of participants' allocation into each treatment group is completely random and unpredictable.

Patient allocation and sequencing are done blindly. All the members of the staff who are involved in performing the enrollment, physicians, nurses and the investigation team as well as patients and their guardians, are masked and uninformed of drug and/or placebo prescription. Referral sequence will be written on the sealed envelopes and patient code will be written in the envelopes and the medication bottles (both drug and placebo). Following patient assessment by the doctor based on inclusion and exclusion criteria, according to the admission sequence, the envelopes with the same number will be opened. According to the patient code, the patients are going to be handed a bottle with the same code. Therefore, the patient is unbeknownst whether the intervention is drug or the placebo.

Collected IPD will be shared after de-identification of participants and patients.

De-identified data will be available starting from April, 2025

Academics employed at various research/university institutions and the industry

No condition is specified.

Saeed Karima, Floor 8th, Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Tel: +982122439975

The applicant would be asked to provide a written formal request letter, containing the importance of the data and the project processes. Following the receipt of request letter, the data would be provided in no more than two weeks.