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Study aim:
Evaluating the effect of the combination of BCc1 & Hep-S on the improvement of clinical & laboratory symptoms of hospitalized COVID-19 patients
Design:
Clinical trial involving a control group with parallel , double blind groups randomized according to block randomization form at phases 1&2 on 120 patients
Settings and conduct:
- Place: wards for hospitalized COVID-19 patients
- Method: by blinding the patients and the clinician
Participants/Inclusion and exclusion criteria:
Inclusion criteria: hospitalized definite COVID-19 patients diagnosed via PCR & CT scan of the lungs, patients' filling out a consent form, patients won't be discharged within 48 hrs, patients' conditions won't be improving within 48 hrs
Exclusion criteria: pregnancy, in lactation, patients with transplants, hereditary immunodeficiency, patients with a record of type 1 diabetes, addiction to alcohol or drugs
Intervention groups:
1. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with BCc1 nanomedicine in 3 servings per day according to the presented dosage.
2. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with Hep-s in 3 servings per day according to the presented dosage.
3. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with the combination of BCc1 & Hep-s in 3 servings per day according to the presented dosage.
4. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with placebo in 3 servings per day according to the presented dosage.
Main outcome variables:
Hospitalization period, morality, CT scan images of the lungs,