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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200318046812N3
Enrollment
500
Registered
2021-01-12
Start date
2020-12-20
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19, virus identified

Interventions

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

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 63 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
?S?everity 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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHasan Saadat

Bagheiat-allah University of Medical Sciences

mghaneister@gmail.com+98 21 8860 0067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026