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.
Comparison of the Effectiveness of COVID-19specific antibody in hyperimmune bovine milk&colostrum with ordinary bovine milk&colostrum on reducing the need for hospitalization and improving clinical symptoms of patients,referred to AlzahraHospital in Isfahan that are taken care of in home.
Design
Double blinded placebo control randomized clinical trial of 600 patients. A random number table is used for randomization.
Settings and conduct
Current study is double blinded, randomized. In that patients of COVID-19diagnosis by PCR test refereed to the COVID-19test clinics based on the random number table are divided in two groups. After explaining the study and receiving consent form one group is given 150cc of hyperimmune milk twice a day morning and evening and the other group is given 150cc of ordinary milk twice daily.Milk packs are named as milkB and milkA. Executives, patients and distributor are not informed of the milks qualities.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:patients of COVID-19 with positivepolymerase chain reaction (PCR) test;Lack of hospitalization indication;Oxygen Saturaion more than93%;RespiratoryRate more than24;Age more than18years old;signing of consent form;A maximum of 10days have elapsed since the onset of symptoms.Exclusion Criteria:Patients with immunodeficiency based on biography;Lactose intolerance;Uncontrollable vomit;Using antiviral drugs; Pregnancy;Failure to fill the consent form;Receiving immunosuppressive drugs.
Intervention groups
Effectiveness of hyperimmune bovine milk and colostrum will be orally tested on a group of referral COVID-19 patients to PCR test centers and a group of these patients is determined as control group that will be given normal bovine milk and colostrum.
Main outcome variables
Existence and lack of clinical symptoms such as fever,cough,shortness of breath and no hospitalization need.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200927048849N3
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Hassan Niliahmadabadi
Name of organization / entity
Virus research center of isfahan university
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6334
Email address
nili@shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-20, 1399/12/30
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Effect of hyperimmune bovine milk & colostrum in the healing process of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of research and technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Ave., Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.MUI.MED.REC.1399.1029
Health conditions studied
1
Description of health condition studied
Covid-19 viral pneumonia
ICD-10 code
J12.81
ICD-10 code description
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
Description
Need of Hospitalization during the next 14 days
Timepoint
14 days after using the milk
Method of measurement
By phone call
2
Description
Need to go to the emergency room during 14 days
Timepoint
14 days after using the milk
Method of measurement
By phone call
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
Mortality rate during 28 days after beginning of the disease
Timepoint
28 days after beginning of disease
Method of measurement
By phone call
8
Description
ICU need during 28 days after beginning the disease
Timepoint
28 days after beginning of disease
Method of measurement
By phone call
Secondary outcomes
empty
Intervention groups
1
Description
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)..
Category
Treatment - Drugs
2
Description
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).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Health and Health Center of the state
Full name of responsible person
Reza Fadae
Street address
Health Department Province, Ebn E Sina Ave.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۳۷۴
Phone
+98 31 3668 5490
Fax
+98 31 3669 9357
Email
Health@mui.ac.ir
Web page address
https://phc.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university
Full name of responsible person
Rasoul Roknizadeh
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2171
Fax
+98 31 3793 2170
Email
research.deputy@dean.ui.ac.ir
Web page address
https://ui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan Oil Refinery
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Zeitoon Isfahan Vaccine Innovators Company
Full name of responsible person
Hassan Nili Ahmadabadi
Street address
Parvin Street
City
Isfahan
Province
Isfehan
Postal code
8198887141
Phone
+98 31 3559 1831
Fax
+98 31 3559 1833
Email
zeitoonisfahan@yahoo.com
Web page address
http://www.zeitoonisfahan.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zeitoon Isfahan Vaccine Innovators Company
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
3
Sponsor
Name of organization / entity
Biotechnology Investment Support Fund
Full name of responsible person
Mehdi deylam salehi
Street address
No. 6, East Saeb Tabrizi Ave., North Shirazi Ave., Molasadra Ave.
City
Tehran
Province
Tehran
Postal code
1991734385
Phone
+98 21 8803 3910
Fax
+98 21 8803 3910
Email
info@biotechfund.ir
Web page address
http://biotechfund.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Biotechnology Investment Support Fund
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Virus research center of Isfahan university
Full name of responsible person
Hassan Niliahmadabadi
Position
Retired full professor of shiraz university and virology consultant and deputy of the virus research