COVID-19 trials registries data warehouse

http://en.irct.ir/trial/60503

Dr. Mohammad Reza Naghipour

naghi@gums.ac.ir

2022-01-02

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Pregnant women with mild / moderate COVID-19 hospitalization in Al-Zahra Hospital in Rasht Diagnosis based on a positive PCR or antigen test results Hospitalization on the day of admission Onset of Covid symptoms up to 5 days before admission to the study Gestational age>12 weeks Age≥ 16 years fever (oral temperature ≥37.2 ° C) Having at least one of the criteria of respiratory rate≥24 per minute or oxygen saturation < 93 (without oxygen) Pa2 / Fi2 Completion of informed consent form

Existence of any obstetric problems such as premature rupture of the amniotic membrane, placental abruption History of receiving probiotic supplement for up to one week before enrollment Presence of underlying diseases and gastrointestinal disorders such as IBD Presence chronic diseases under treatment (such as asthma and allergies, heart failure) and acquired or congenital immunodeficiencies

2

Rasht University of Medical Sciences

16

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

80

Duration from the start of the study until the improvement of clinical symptoms Duration from the start of the study until the improvement of paraclinical symptoms

Phase 3

[{"arm_notes": "", "treatment_id": 1940, "treatment_name": "Synbiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]