Protocol summary

Study aim
Evaluation of the efficacy and safety of using rabbit polyclonal antibodies in the treatment of patients with severe covid 19 infection (COVID-19)
Design
Clinical evaluation has a parallel, unblinded, randomized control group
Settings and conduct
The study is being conducted in Tehran and at Baqiyatallah Al-Azam Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient over 18 years of age, signature form of conscious consent to participate in the study by himself or the patient's guardian, patient with moderate to severe Severe disease. Non-inclusion criteria: People with a history of allergies to blood products such as IVIG or albumin. The patient has critical conditions such as multiple organ failure. pregnant women. Breastfeeding mothers. The patient is receiving treatment and medication outside the standard COVID 19 treatment protocol, and the physician believes that the patient is not suitable to participate in this trial. Known sensitivity to rabbit proteins
Intervention groups
CoviGlobulin (rabbit polyclonal antibody) drug candidate: Receive CoviGlobulin r at a dose of 1-3 mg per kg body weight (1-3 mg / kg / d) for 2–4 days 2) Receive basic COVID-19 treatment based on the protocol approved by the Ministry of Health control group : 1) Receive basic COVID-19 treatment based on the protocol approved by the Ministry of Health
Main outcome variables
1- Clinical improvement within 14 days after patient admission 2- The mortality of patients within 14 days is determined on a daily basis and based on examination and clinical history.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200508047346N1
Registration date: 2020-05-13, 1399/02/24
Registration timing: prospective

Last update: 2020-05-13, 1399/02/24
Update count: 0
Registration date
2020-05-13, 1399/02/24
Registrant information
Name
Mahdi Behdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6411 2144
Email address
behdani73042@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Rabbit polyclonal antibody (CoviGlobulin) in patients with coronavirus COVID-19 virus moderate to severe
Public title
Evaluation of the effectiveness of rabbit antibody against coronavirus in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Based on clinical and laboratory symptoms, the person has been confirmed to have COVID-19. The patient is over 18 years old The patient is hospitalized and shows one of the moderate to severe clinical symptoms of COVID-19, including the following: Severe clinical symptoms: Having any of the following: shortness of breath, respiratory rate more than 30 times per minute , Oxygen saturation of blood less than 93% (at rest), ratio of arterial oxygen pressure to inhaled oxygen less than 300, pulmonary infiltration more than 50% over 24 to 48 hours. Volunteer to participate in the study and sign a conscious consent form for yourself or your legal guardian. Admission of patients is random and grouped to participate in the study (control or treatment group). The patient is hospitalized before the end of the clinical study and is available for any further evaluation
Exclusion criteria:
People with a history of allergies to blood products such as IVIG or albumin. The patient has critical conditions such as multiple organ failure. pregnant women. Breastfeeding mothers. The patient is receiving treatment and medication outside the standard COVID 19 treatment protocol, and the physician believes that the patient is not suitable to participate in this trial. Known sensitivity to rabbit proteins
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Making a random number sequence of patients is done online by the sealed envelop site. Using randomly placed blocks, blocks (the size of each block is 4) will be made for a total of 124 patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Mulla Sadar, Sheikh Baha'i, Baqiyatallah Al-Azam Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.BMSU.REC.1399.110

Health conditions studied

1

Description of health condition studied
Emerging pneumonia caused by the covid virus 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Clinical improvement within 14 days after patient admission
Timepoint
every day
Method of measurement
2-point decrease in the patient's level compared to the admission time level. 6-point scale includes: score 6: death score 5: hospitalization for ECMO and (or) mechanical ventilation score 4: non-invasive ventilation or high-current oxygen therapy score 3: hospitalization for oxygen therapy (not high current and mechanical ventilation) Not required) Score 2: Hospitalization Score 1: Clearance

2

Description
Patient mortality rate in 14 days
Timepoint
every day
Method of measurement
Clinical observation

Secondary outcomes

1

Description
Hospitalization ِِDuration
Timepoint
Patient discharge day
Method of measurement
Examination and history

2

Description
ICU Hospitalization Duration
Timepoint
everyday
Method of measurement
Examination and history

3

Description
Invasive mechanical ventilation
Timepoint
every day
Method of measurement
Examination and history

4

Description
ECMO duration
Timepoint
every day
Method of measurement
Examination and history

5

Description
Proportion of PCR negative (3 AND 7 days after transfusion)
Timepoint
3 days and 7 days after injection
Method of measurement
PCR

6

Description
Clinical characteristics including, Fever, Respiratory frequency(RF) and PaO2/FiO2
Timepoint
every day
Method of measurement
Examination and history

Intervention groups

1

Description
The intervention group includes patients with moderate to severe COVID-19 symptoms who have been diagnosed with coronavirus by PCR: (1) CoviGlobulin (rabbit polyclonal antibody) intake of 1-3 mg per kg body weight Body (1-3 mg / kg / d) for 2-4 days. (2) Receive the basic COVID-19 treatment based on the protocol approved by the Ministry of Health
Category
Treatment - Other

2

Description
Control group: Receive basic COVID-19 treatment based on protocol approved by the Ministry of Health
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Al-Azam Hospital
Full name of responsible person
Dr. Mostafa Ghanei
Street address
18/5000 Mulla Sadra, Sheikh Baha'i
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
mghaneister@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kowsar Biotechnology Co.
Full name of responsible person
Sirous Zeinali
Street address
No. 41, Kosar Complex, 3rd Floor, Majlesi St., Valiasr St., Above Fatemi St., Tehran, Tehran
City
Tehran
Province
Tehran
Postal code
1595645513
Phone
+98 21 8893 9150
Email
kbc@kawsar.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kowsar Biotechnology Co.
Proportion provided by this source
100
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Kowsar Biotechnology Company
Full name of responsible person
Sirous Zeinali
Position
CEO
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
No. 41, Kosar Complex, 3rd Floor, Majlesi St., Valiasr St., Above Fatemi St., Tehran, Tehran
City
Tehran
Province
Tehran
Postal code
1595645513
Phone
+98 21 8893 9150
Email
zeinali@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mostafa Ghanei
Position
full Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Mulla Sadra, Sheikh Baha'i, Baqiyatallah Al-Azam Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 82162
Email
mghaneister@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kowsar Biotechnology Company
Full name of responsible person
Mahdi Behdani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 41, Kosar Complex, 3rd Floor, Majlesi St., Valiasr St., Above Fatemi St., Tehran, Tehran
City
Tehran
Province
Tehran
Postal code
1595645513
Phone
+98 21 8893 9150
Email
behdani73042@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the publication of the article, confidential information such as patient and hospital details, etc. will be deleted and other information will be provided to researchers.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Medical professionals
Under which criteria data/document could be used
Medical professionals can access data for research purposes
From where data/document is obtainable
Refer to the email of the responsible author
What processes are involved for a request to access data/document
Official and academic email to the responsible author
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