Evaluation of the effects of resveratrol consumption on inflammatory and biochemical parameters of patients with Covid ۱۹

Evaluation of the effect of resveratrol consumption on inflammatory and biochemical factors in patients with Covid 19

This study is a randomized, double-blinded, controlled clinical trial with a parallel group design of 140 patients( 70 patients in each group). The random allocation method in this study will be per mutated block randomization.

The patients with Covid-19 will be going to Persian Gulf Hospital, Bushehr, Iran, to do the PCR test and the assessment of their conditions for entering the trial. After completing the consent and questionnaire forms, the patients will receive the resveratrol and placebo packages which are labeled based on computer-generated codes. Each of these codes is determined based on the sequence of random allocation of individuals to groups. Then, blood collection will take place at this time and after the 10 days of intervention. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. The patient and the outcome evaluator will not know the type of intervention.

Inclusion criteria: Age above 18 years. Having Covid -19, Lung involvement approved by CT scan. Exclusion criteria:Pregnant ladies The patients with any allergic or sensitivity,

The patients in the intervention group will receive 250 mg resveratrol capsules (99% pure, Biotivia, Bioceuticals International Sri, Italy), 3 times a day for 10 days. The patients in the placebo group will receive 250 mg of placebo capsules (totally inert nitrocellulose, Biotivia, Bioceuticals International Sri, Italy) supplementation 3 times a day for 10 days.

Lung involvement,ESR; CBC index; CRP

The random allocation method in this study will be permutated block randomization, where T represents the person receiving the intervention and C represents the person who receive the Placebo. This method is performed by considering blocks of sizes 4 patients so that the total number of 4 permutations is equal to 6 blocks as follows: (C,C,T,T), (T,T,C,C), (C,T,T,C), (C,T,C,T), (T,C,C,T), (T,C,T,C), (C,T,C,T) Then, a number of 35 blocks will be randomly selected with replacement from these 6 blocks. Finally, the desired list of 35 blocks of 4 (4 * 35 = 140 total number of samples) is generated and the order of assignment to each of the samples participating in the study is determined. These steps are performed using R software version 3.6.3

First, all resveratrol and placebo capsules are prepared in the same shape and size and in packs of 20 for distribution to patients. The resveratrol and placebo packages are then labeled based on computer-generated codes (without indication of its content). Each of these codes is determined based on the sequence of random allocation of individuals to groups. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. On the other hand, the shape, size, and type of packaging of the resveratrol and placebo are exactly the same, so the patient and the outcome evaluator will not know the type of intervention.

The Deputy of Research is responsible to provide the information and documents to the participants in the Trial

After the trial was over and the results were analyzed, for a period of one year, access to the document is possible

The data and other documents of the study will be given to my colleagues at my University and other researchers and academic members from different universities worldwide.

If the researcher wants the document to use in the following research. The patients who want to know about the results of the examination

The main investigator responsible for the trial, or the deputy of Research should be contacted

The applicants should submit a request letter to the principal investigator, or a request from the deputy of research. Then, the request will be assessed by these authorities and the right files and documents will be submitted to the requester for a period of one or two weeks.