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IRCT20200318046812N3 IRCT 2021-01-12 Bagheiat-allah University of Medical Sciences Efficacy and safety of "BioBoost" supplement on the incidence of COVID-19 symptoms of asymptomatic family members of COVID-19 patients 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 2020-12-20 anticipated 500 Complete https://irct.ir/trial/53187 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 COVID-19. Intervention 1: ''Intervention group:'' In this group, probiotics are given to the patients' families. Biomus supplement consists of 12 essential vitamins and minerals along with probiotics (a mixture of three native Iranian strains including Lactobacillus casei, L. rhamnosus and L. helveticus ). All these items are prepared in one capsule to strengthen the immune system and digestive system against viral and bacterial diseases.Three capsules of medicine/placebo are delivered daily to the participants after receiving informed consent and the eligibility of the cluster at the initial visit. In follow-up visits, after receiving the previous drug pack/placebo, the new treatment is sent to the patient's family using a courier. The amount of medicine/placebo delivered is enough until the next visit. Intervention 2: ''Control group'': Placebo is given to patients three times a day. Yes - There is a plan to make this available What will be shared: Potential data such as information about the main outcome can be shared after the confidentiality of individual information When: Access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The use of data and its analysis is allowed if be cited Where to obtain: Dr Mostafa Ghanei; Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.Email: mghaneister@gmail.com; Phone: +9821 88600067 How to obtain: 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. Comments:
public Hasan Saadat
baqiyatallah Hospital, Mollasadra Ave., Vanak Square ., Tehran
Tehran Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶. +98 21 8860 0067 mghaneister@gmail.com Bagheiat-allah University of Medical Sciences scientific Amir Hosein Ghazale
Baqiyatallah Hospital, Mollasadra Ave., Vanak Square ., Tehran
Tehran Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶. +98 21 8860 0067 mghaneister@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Confirmation of infection by PCR in a family member Informed written consent Living in Tehran Number of family members between 2 and 5 Age between 18 to 63 years No prognostic signs of Covid-19 disease two weeks before enrollment 18 years 63 years Both Not participating in another clinical trial in the last three months Do not use other supplements (containing vitamins, minerals, and probiotics) No documented history of Covid-19 infection in healthy family members Pregnancy / breastfeeding Drug sensitivity to the compounds in the intervention Temporary residence or immigration and consecutive relocation from Tehran Use similar supplements U07.1 COVID-19, virus identified Prevention Placebo ''Intervention group:'' In this group, probiotics are given to the patients' families. Biomus supplement consists of 12 essential vitamins and minerals along with probiotics (a mixture of three native Iranian strains including Lactobacillus casei, L. rhamnosus and L. helveticus ). All these items are prepared in one capsule to strengthen the immune system and digestive system against viral and bacterial diseases.Three capsules of medicine/placebo are delivered daily to the participants after receiving informed consent and the eligibility of the cluster at the initial visit. In follow-up visits, after receiving the previous drug pack/placebo, the new treatment is sent to the patient's family using a courier. The amount of medicine/placebo delivered is enough until the next visit. ''Control group'': Placebo is given to patients three times a day ُSُeverity of cough. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone followup. ُSeverity of shortness of breath. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone followup. Preentation of fever, headache, .. as a Yes/ no. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone follow-up. Recording the severity of symptoms by comparing Likert from a score of 1 to 10. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone follow-up. The duration of symptoms and duration of hospitalization based on the date of onset and date of remission. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone follow-up. Bagheiat-allah University of Medical Sciences Approved 2020-12-14 Chamran Hospital Ethics Committee Shahid Chamran Hospital, Sanaye St., Shahid Langari St., Nobniad Sq., Tehran Tehran Tehran Iran (Islamic Republic of)