Assessment of additive effect of crocin in Covid-19 patients

Additive effects of crocin on clinical symptoms, lung HRCT, total and differential WBC count and blood levels of some inflammatory factors, in Covid-19 patients admitted to Imam Reza hospital, Mashhad

A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial Triple masking (Participant, Investigator, Outcomes Assessor and Statistician)

Patients, after signing informed consent, will be randomly allocated to the following two groups. Placebo Group in which, patients (n=30) will receive placebo tablets and Crocin Group in which, patients (n=30) will receive Crocin 15 mg, two times per day, for 14 days. All subjects will receive the conventional anti-Covid-19 therapy and no cessation in such treatment will be considered.

Inclusion criteria: 1. Confirmed cases of Covid-19 2. Patients admitted to hospital Covid-19 general wards 3. Being 20-60 years old, of either sex. 4. Ability to sallow oral medication. 5. Patients without immunodeficiency and gastrointestinal disorders 6. Not being pregnant/breast feeding Exclusion criteria 1. Being allergic to saffron/crocin 2. Inability to swallow oral medication during admission

(1) Placebo Group in which patients (n=30) will receive placebo tablets, twice a day, for 14 days. (2) Crocin Group in which, patients (n=30) will receive Crocin 15 mg, twice a day, for 14 days.

Clinical symptoms, hospital stay data and lung HRCT as well as total and differential WBC count, and blood levels of biochemical factors (CRP, ESR, LDH, TNF-α) will be collected before initiation of the treatment (day 0), and on the final day (day 14). Biochemical parameters will also evaluate one week after starting the treatment (day 7).

Simple randomization method (using https://www.Randomization.com-generated sequence) In this method, using website https://www.Randomization.com that generates the random number sequences, the random number sequences are determined for the required sample size (n=30 in each group). Following, after patients enter the study based on the inclusion criteria, according to the list of the random number sequences generated, individuals are assigned to one of the intervention and placebo groups, and this continues until the number of patients in each group is completed.

Masking Description: Drugs will be packed and labelled . No information on the randomization schedule or the contents of drug packs will be available to patients, investigators, care providers and outcomes assessors and they will be blinded. The patients will be blinded in the sense that they do not know whether they were receiving the placebo or crocin. They randomly assign to one of the two groups. The investigators doing the interventions will be blinded as to the contents of the drug using drugs labelling. Also care providers and outcomes assessors shall be blinded as to what group the patient belongs to. One person in the project who does not belong to any of the groups of patients, investigators, care providers and outcomes assessors, will oversee on blinding method.

Dr. Ramin Rezaee is committed to presenting all the achievements of the project in accordance with the framework of the National Institute for Medical Research Development in the Islamic Republic of Iran.