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IRCT20200927048849N2 IRCT 2021-01-06 Isfahan university Effect of hyperimmune bovine milk & colostrum in the healing process of COVID-19 patients Comparison of the Effectiveness of COVID-19 specific antibody in hyperimmune bovine milk & colostrum with ordinary bovine milk & colostrum in improving clinical symptoms and laboratory parameters and outcomes of patients with COVID-19 admitted to Hospital 2020-11-27 anticipated 40 Complete https://irct.ir/trial/52537 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Current study is a double blinded randomized clinical trial. Randomization will be done as simple randomization by using random number table. Hospitalized patients of Alzahra hospital of Isfahan with COVID-19 diagnosis will be divided in two groups by using of random number table. After explaining the study and obtaining consent intervention group will be given daily 100 cc of milk of vaccinated cow with antigen of COVID-19 virus as an evening meal. After explaining the study and obtaining consent control group will be given 100 cc of unvaccinated cow's milk. Milk packs are named as Milk A and Milk B . The doctor, patient and distributor of milk do not know about the quality of the milks. Only the factory that pasteurizes is informed of the quality of milks and in the factory milk packs are labeled as A or B, Blinding description: Patients will be divided in two groups by using of random number table. After explaining the study and obtaining consent of patients intervention group will be given 100 cc of hyper immune milk daily as an evening meal. Control group will be given 100 cc of ordinary milk after explaining the study and obtaining consent. Milk packs are named as Milk A and Milk B. The doctor, patient and distributor of milk are not informed of the quality of the milks. 2-3 COVID-19. Intervention 1: Intervention group: Intervention group: Noncritical hospitalized COVID- 19 infected patients. After explaining the study and obtaining consent form the intervention group will be given 100 cc of hyperimmune milk as an evening meal. Intervention 2: Control group: Noncritical hospitalized COVID- 19 infected patients. After explaining the study and obtaining consent the control group will be given 100 cc of ordinary milk as an evening meal. Yes - There is a plan to make this available What will be shared: Results of the processed data would be available When: One year after termination of the project. To whom: Researchers and related authorities in health system on the bases of official request. Conditions: In order to obtain required permission for production of the product. Where to obtain: Written letter to researcher should be send and then after evaluation, proper decision will be made How to obtain: Name and family name: Hassan Nili Ahmadabadi Email: hassanili@yahoo.com Comments:
public Somayeh Sadeghi
No. 4 apartment unit, Parmisa building, alley No. 5, Mehrabad avenue, Mehrabad neighbourhood
Isfahan Iran (Islamic Republic of) 8158913489 +98 31 3261 6331 S.sadeghi117917@gmail.com Esfahan University of Medical Sciences scientific Hassan Niliahmadabadi
No. 5 apartment unit, Parmisa building, alley No. 5, Mehrabad avenue, Mehrabad neighbourhood
Isfahan Iran (Islamic Republic of) 8198887141 +98 31 3261 6334 nili@shirazu.ac.ir Virus research center of isfahan university Iran (Islamic Republic of) Infected patients of COVID-19 based on positive PCR or HRCT result compatible with disease Hospitalization of patient in hospital With oxygen via nasal cannula 93%≤O2 Sat Age >18years old Filling and signing of consent form Allowing the patient to consume food orally 18 years no limit Both Patients with immunodeficiency based on biography Patients with Lactose intolerance based on biography Uncontrollable vomit U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Intervention group: Noncritical hospitalized COVID- 19 infected patients. After explaining the study and obtaining consent form the intervention group will be given 100 cc of hyperimmune milk as an evening meal. Control group: Noncritical hospitalized COVID- 19 infected patients. After explaining the study and obtaining consent the control group will be given 100 cc of ordinary milk as an evening meal. Hospital mortality rate. Timepoint: Daily from intervention. Method of measurement: Physician approval. Mortality rate during 28 days after the beginning of disease. Timepoint: Daily from intervention. Method of measurement: Physician approval during admission and via tell contact after discharge. Admission rate of patient in ICU (based on hospital protocols). Timepoint: Daily from intervention. Method of measurement: Refer to the patient's file. Days that patient needs to be hospitalized. Timepoint: Daily from intervention. Method of measurement: Refer to the patient's file. O2 Saturation. Timepoint: Measuring in the first day and days 3 and 5 or in the day of discharge. Method of measurement: Pulseoximetry. Improvement rate of clinical symptoms such as dyspnea and fever. Timepoint: Measuring in the first day and days of 3 and 5 or in the day of discharge. Method of measurement: Data gathering sheet. Erythrocytes sedimentation rate. Timepoint: Measuring in the first day and days of 3 and 5 or in the day of discharge. Method of measurement: Blood test via wester green method. C-Reactive protein. Timepoint: Measuring in the first day and days of 3 and 5 or in the day of discharge. Method of measurement: Blood test. Lymphocytopenia. Timepoint: Measuring in the first day and days of 3 and 5 or in the day of discharge. Method of measurement: Blood test (CBC/Diff). Isfahan Science and Technology town Zeitoon Isfahan Vaccine Innovators Company Isfahan Oil Refinery Isfahan Science and Technology town Zeitoon Isfahan Vaccine Innovators Company Approved 2020-11-06 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)