COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05115019

Not reported

Not reported

2021-11-10

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: sign the informed consent before initiating the selection procedures. patients infected with sars-cov-2 (pcr +) with mild symptoms up to 7 days that do not require hospitalization, from the onset of symptoms. mild symptoms, defined as the following criteria: cough, headache, fever (>37.5ºc), muscular pain and shortness of breath. people ≥ 18 years. peripheral oxygen saturation (spo2) more than 94% on room air, not requiring supplemental oxygen. availability to meet the requirements of the protocol.

pregnancy or breastfeeding. suspected of active viral or bacterial infection other than sars-cov-2. participation in another interventional study with potentially conflicting medication within 30 days before screening. severely immunocompromised people (data gathered from preexisting medical records and history taking). this exclusion category includes: subjects with human immunodeficiency virus (hiv-1). neutropenic subjects with less than 500 neutrophils / mm3. subjects with solid organ transplantation. subjects with bone marrow transplantation. subjects undergoing chemotherapy. subjects with primary immunodeficiency. severe lymphopenia with less than 400 lymphocytes / mm3. treatment with any anti-cytokine therapy. oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months. malignancy, or active solid or non-solid lymphoma from the previous two years. bcg vaccination in the last 10 years. chloroquine or hydroxychloroquine administration in the last two weeks soy allergy direct involvement in the design or execution of the mycovind clinical trial. do not have a smartphone. detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol. any other findings that, at the discretion of the investigator, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of probiotics.

2

PT. Innovative Pharma Solutions

18

100

None

Mild disease at enrollment

1: Mild disease at enrollment

0

Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]