Efficacy and safety of "BioBoost" supplement on the incidence of COVID-19 symptoms of asymptomatic family members of COVID-19 patients: A Randomized cluster clinical trial, parallel, Phase 3, doubled blinded and placebo controlled

Use of probiotics to prevent the symptoms of Covid-19 in families where one of the members has Covid-19 disease

This single-center study was in coordination with Keyvna Laboratory and Baqiyatallah University of Medical Sciences. After confirming the disease by PCR, obtaining informed consent from the patient and his family, and reviewing the inclusion/exclusion criteria to determine eligibility, the patients were considered as an index case. The study designed and implemented as a cluster.

The study was conducted using electronic forms and an electronic data collection management system. The process of clearing and locking data was managed online. Assessor, physician, and statistical analysis are blind. This single-center study was performed in coordination with Keyvan Laboratory in Tehran and Baqiyatallah University of Medical Sciences. .

• Inclusion criteria: 1- Confirmation of PCR infection in a family member 2- Informed written consent 3. Not participating in another clinical trial in the last three months 4- Do not use other supplements (containing vitamins, minerals, and probiotics) 5. Age between 18 to 63 years 6- No prognostic signs of Covid disease-19 two weeks before the study 7- No documented history of Covid-19 infection in healthy family members • Exclusion criteria: 1. Pregnant women/breastfeeding 2. Having a history of member transplants 3. Having a history of bowel surgery 4. Taking immunosuppressive drugs 5. Sensitivity to probiotic supplement ingredients Exclusion criteria 1. severe adverse event 2. reluctant 2. Reluctance to continue

Group 1: Giving probiotics to patients' families Group 2: giving a placebo to patients' families

Estimating the incidence and severity of cough Estimation of the incidence and severity of shortness of breath

This study is designed as a cluster. The index patient was diagnosed with Covid-19 and the patient's family members were included in the study if they met the inclusion criteria and were assigned to one of the treatments. Random codes are generated by the permutation block method with variable block sizes to the estimated number of clusters. A dedicated code for each family member is tagged on the box along with a randomization code.

There is a special code on the box corresponding to the randomization list. In order to enter the patient and determine the relevant box, the project management is inquired. Therefore, the patient and the evaluator and statistical analyzer will only see the label on the probiotic.

Potential data such as information about the main outcome can be shared after the confidentiality of individual information

Access period starts 6 months after the results are published

The data will be available only to researchers working in academic and scientific institutions

The use of data and its analysis is allowed if be cited

Dr Mostafa Ghanei; Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.Email: mghaneister@gmail.com; Phone: +9821 88600067

The processes that must be followed by the applicant for these documents or data files will include a letter of request, a letter of request from the center or university of origin, acceptance of the destination university, and proof of eligibility to receive the information.