The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial

This clinical trial aims to assess the effect of propolis on clinical symptoms in patients with coronavirus.

This study is a double-blind, placebo-controlled, randomized phase 2 clinical trial evaluating the effect of propolis on clinical symptoms in patients with coronavirus. In this study, 80 eligible participants will be randomly assigned to either the intervention or the control group. The randomization sequence will be generated using a random-number table.

In this study, patients with coronavirus will be recruited from the Al-Zahra hospital in Isfahan. Participants who meet entry criteria will be randomly assigned to the propolis group or the placebo group. The participant's assignment will be concealed from all participants and investigators, with the exception of the study pharmacist.

The inclusion criteria are the age of 18 to 75 years, willingness to participate with written informed consent, and the diagnosis of coronavirus based on the PCR test. The exclusion criteria are the current use of warfarin, current use of propolis supplement, and presence of sensitivity to bee products.

Participants in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for 2 weeks. Participants in the placebo group will receive an identical tablet placebo (containing 300 mg microcrystalline cellulose ) three times a day for 2 weeks.

Respiratory Rate, Chest CT scan, High-sensitivity C-reactive protein, Erythrocyte Sedimentation Rate, Severity and number of coughs

Eligible participants will be randomly assigned to either the propolis group or the placebo group. Randomization will be performed in a 1:1 ratio with the use of block sizes of 4, with stratification according to the gender. Randomization sequences will be prepared by the study pharmacist with the use of a random number table.

Assignment of participants to the study groups will be concealed from participants and investigators, with the exception of the study pharmacist and care provider, until the end of the study and data analysis. The study pharmacist who will be aware of the assignments will be prepared the placebo tablets similar to the propolis tablet in color, odor, taste, shape, size, and weight. Drug containers will be the same in terms of shape, color, odor, size, and weight and will be kept inside numbered, opaque, and sealed envelopes which will be completely impermeable to light.

The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.

The non-identifiable individual participant data will become available after the publication of the relevant articles.

The non-identifiable individual participant data will become available to other researchers in academic institutions.

The non-identifiable individual participant data can only be used for research.

The non-identifiable individual participant data will be obtainable by sending an e-mail to Mr. Karim Sohrabi (Email: sohrabi@mail.mui.ac.ir).

Other researchers in academic institutions can send their request by e-mail to Mr. Karim Sohrabi (Email: sohrabi@mail.mui.ac.ir). The data will be sent to them after consulting and approving the research team.