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
Comparison of the Effectiveness of Covid-19 specific antibody in hyperimmune bovine milk & colostrum with ordinary milk & colostrum in improving clinical symptoms and laboratory parameters and outcomes of Covid-19 hospitalized patients
Design
Double blind placebo control randomized clinical trial of 40patients. A random number table is used for randomization
Settings and conduct
In first phase of clinical trial hyperimmune bovine milk is given to 40healthy men. If after 14days they hadn't shown upper infection rate compared with ordinary people the trial goes to next phase. In that hyperimmune colostrum and milk is given to 40hospitalized patients of Alzahra-hospital once a day for 5days and vital symptoms and experimental factors are assessed.
Current study is double blinded, randomized. In that hospitalized patients of Covid- 19 diagnosis based on the random number table are divided in two groups. Intervention group is given 100cc of hyperimmune milk as an evening meal and control group is given 100cc of ordinary milk. Milk packs are named as milkA (hyperimmune) and milkB (ordinary). The doctor, patients and distributor are not informed of the milks qualities.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infected Covid- 19 patients with positive PCR result; Hospitalization; With oxygen via nasal cannula O2sat more than 92%; O2 Sat more than 93%; Age more than18; Filling and signing of consent form; Allowing the patient to consume food orally
Exclusion Criteria: Immunodeficiency; Lactose intolerance ; Uncontrollable vomit based on biography
Intervention groups
Hyperimmune colostrum and milk will be orally tested on hospitalized noncritical patients of Covid- 19 selected by random sampling and a group determined as control group is given ordinary colostrum and milk.
Main outcome variables
Length of hospital stay of experimental group compared with control group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200927048849N2
Registration date:2021-01-06, 1399/10/17
Registration timing:retrospective
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
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
2020-11-27, 1399/09/07
Expected recruitment end date
2020-12-20, 1399/09/30
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 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
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 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
Exclusion criteria:
Patients with immunodeficiency based on biography
Patients with Lactose intolerance based on biography
Uncontrollable vomit
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
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
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-06, 1399/08/16
Ethics committee reference number
IR.MUI.MED.REC.1399.672
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Hospital mortality rate
Timepoint
Daily from intervention
Method of measurement
Physician approval
2
Description
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
3
Description
Admission rate of patient in ICU (based on hospital protocols)
Timepoint
Daily from intervention
Method of measurement
Refer to the patient's file
4
Description
Days that patient needs to be hospitalized
Timepoint
Daily from intervention
Method of measurement
Refer to the patient's file
Secondary outcomes
1
Description
O2 Saturation
Timepoint
Measuring in the first day and days 3 and 5 or in the day of discharge
Method of measurement
Pulseoximetry
2
Description
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
3
Description
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
4
Description
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
5
Description
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)
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Somayeh Sadeghi
Street address
Soffe Blvd, Al-Zahra University Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 1668 4510
Email
s.sadeghi117917@gmail.com
Web page address
http://alzahra.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
Isfahan Science and Technology town
Full name of responsible person
Jafar Gheisary
Street address
Isfahan University of Technology Blvd
City
Isfahan
Province
Isfehan
Postal code
۸۴۱۵۶۸۳۱۱۱
Phone
+98 31 3386 5355
Fax
+98 31 3386 2355
Email
dabirkhane@istt.ir
Web page address
https://www.istt.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Science and Technology town
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
3
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?