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IRCT20200927048849N3 IRCT 2021-03-17 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 hyper-immune bovine milk & colostrum with ordinary bovine milk & colostrum on reducing the need for hospitalization and improving clinical symptoms of patients with COVID-19 that are taken care of in home. 2021-03-20 anticipated 600 Complete https://irct.ir/trial/52429 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients list with positive PCR is received through health center daily and numbered. Participants of the study are divided in two groups Using a simple randomization method using a table of random numbers and according to the entry and exit criteria. Such that the patients with even number are given hyperimmune milk and patients with odd number are given ordinary milk, Blinding description: Referral patients to clinic with COVID-19 diagnosis by positive PCR from Nazopharynx are divided in two groups using a simple randomization method using a table of random numbers. Milks have two types hyperimmune and ordinary that are named as A and B on the top but their packaging are quite the same. One group is given milk A (ordinary or placebo) and the other group is given milk B or hyperimmune milk. The doctor, patient and distributor are not informed of the milks differences. 3 Covid-19 viral pneumonia. Intervention 1: Intervention group: Referred COVID-19 patients to clinic of Alzahra hospital after explaining the study and obtaining consent the will be given twice a day, morning and evening 150 cc of vaccined cow's milk by COVID-19 virus antigen (hyperimmune milk). Intervention 2: Control group: Referred Covid-19 patients to clinic of Alzahra hospital in Isfahan after explaining the study and obtaining consent form will be given twice a day, morning and evening 150 cc of ordinary bovine milk (placebo milk). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Hassan Niliahmadabadi
No. 5 apartment unit, Parmisa building, alley No. 5, Mehrabad avenue, Mehrabad neighbourhood
Isfahan Iran (Islamic Republic of) 8158913488 +98 31 3261 6334 nili@shirazu.ac.ir Virus research center of Isfahan university 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 Polymerase Chain Reaction test Lack of hospitalization indication based on country protocol O2 Saturation more than 93% on the first visit Respiratory rate more than 24 on the first visit Age more than 18 years old Filling and signing of consent form A maximum of 10 days have elapsed since the onset of disease symptoms 18 years no limit Both Patients with immunodeficiency based on biography Lactose intolerance based on biography Uncontrollable vomiting Using antiviral drugs Pregnancy Failure to fill out the consent form Receiving immunosuppressive drugs J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Drugs Placebo Intervention group: Referred COVID-19 patients to clinic of Alzahra hospital after explaining the study and obtaining consent the will be given twice a day, morning and evening 150 cc of vaccined cow's milk by COVID-19 virus antigen (hyperimmune milk).. Control group: Referred Covid-19 patients to clinic of Alzahra hospital in Isfahan after explaining the study and obtaining consent form will be given twice a day, morning and evening 150 cc of ordinary bovine milk (placebo milk). Need of Hospitalization during the next 14 days. Timepoint: 14 days after using the milk. Method of measurement: By phone call. Need to go to the emergency room during 14 days. Timepoint: 14 days after using the milk. Method of measurement: By phone call. No fever and appearance of it. Timepoint: In days of 3, 5, 7, 10 and 14 after beginning the treatment. Method of measurement: By phone call. No cough and appearance of it. Timepoint: In days of 3, 5, 7, 10 and 14 after beginning the treatment. Method of measurement: By phone call. No shortness of breath and appearance of it. Timepoint: In days of 3, 5, 7, 10, 14 after beginning the treatment. Method of measurement: By phone call. No muscular pain and appearance of it. Timepoint: In days of 3, 5, 7, 10, 14 after beginning the treatment. Method of measurement: By phone call. Mortality rate during 28 days after beginning of the disease. Timepoint: 28 days after beginning of disease. Method of measurement: By phone call. ICU need during 28 days after beginning the disease. Timepoint: 28 days after beginning of disease. Method of measurement: By phone call. Zeitoon Isfahan Vaccine Innovators Company Biotechnology Investment Support Fund Isfahan Oil Refinery Zeitoon Isfahan Vaccine Innovators Company Biotechnology Investment Support Fund Approved 2021-02-21 Ethics committee of Isfahan University of Medical Sciences Deputy of research and technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Ave., Azadi Sq. Isfahan Isfehan Iran (Islamic Republic of)