Evaluation of the effect of subcutaneous adalimumab on the prognosis of patients with COVID-19: a pilot study in patients admitted to Afzalipour hospital in Kerman
Evaluation of the effect of subcutaneous adalimumab on the prognosis of patients with COVID-19
Design
Clinical trial with parallel control group with parallel, non-blind, non-randomized phase 2 on 20 patients.
Settings and conduct
In Afzalipour Hospital, on the first day of hospitalization of this study, which will be performed non-blindly, patients of the intervention group will receive 40 mg subcutaneous adalimumab made by Sinagen factory. In the intervention group, as in the control group, adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients suffering severe COVID-19; patient consent; age 60_70 years old.
Exclusion criteria: Fever ( body temp above 40°C); any active bacterial or fungal infection; positive blood and urine culture; history of chronic obstructive pulmonary disease; history of tuberculosis, heart failure, infectious skin wounds; history of multiple sclerosis; very severe/critical stage of the disease (shock, encephalopathy, myocardial lesion, coagulation, and renal impairment); abnormal liver tests in the form of liver enzymes more than 2 times normal; glomerular filtration rate (GFR) less than or equal to 30.
Intervention groups
Patients of the intervention group will receive 40 mg subcutaneous adalimumab made by Sinagen factory. In the intervention group, as in the control group, adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol.
Main outcome variables
C-reactive protein (CRP); Lactate Dehydrogenase (LDH); SpO2 level; Respiratory rate per minute; Hospitalization stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220112053701N1
Registration date:2022-02-26, 1400/12/07
Registration timing:registered_while_recruiting
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Amirhossein Arabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 9950
Email address
aha6765@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of subcutaneous adalimumab on the prognosis of patients with COVID-19: a pilot study in patients admitted to Afzalipour hospital in Kerman
Public title
Evaluation of the effect of subcutaneous adalimumab on the prognosis of patients with COVID-19: a pilot study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe COVID-19 (respiratory rate more than 30 per minute or oxygen saturation less than 90% or more than 50% lung parenchyma involvement on the patient's CT scan)
Patient's consent
Age: 60_70 years old
Exclusion criteria:
Fever (body temp above 40°C)
Any active bacterial or fungal infection
Positive blood and urine culture
History of chronic obstructive pulmonary disease
History of tuberculosis
Heart failure
Infectious skin wounds
History of multiple sclerosis
Very severe/critical stage of the disease (shock, encephalopathy, myocardial lesion, coagulation, and renal impairment)
abnormal liver tests in the form of liver enzymes more than 2 times normal
GFR less than or equal to 30
Age
From 60 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Kerman University of Medical Sciences
Street address
Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-02-11, 1400/11/22
Ethics committee reference number
IR.KMU.REC.1399.655
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
C-reactive protein (CRP)
Timepoint
First and 5th day
Method of measurement
using latex agglutination tests and a bionic CRP quantitative detection kit
2
Description
Lactate Dehydrogenase (LDH)
Timepoint
First and 5th day
Method of measurement
routine commercial kits (Pars Azmoon Co.,Iran).
3
Description
SpO2 level
Timepoint
First and 5th day
Method of measurement
by pulse oximeter
4
Description
Respiratory rate per minute
Timepoint
First and 5th day
Method of measurement
Counting the number of breaths for one minute by counting how many times the chest rises
5
Description
Hospitalization stay
Timepoint
discharge time
Method of measurement
Counting the number of days hospitalized
Secondary outcomes
empty
Intervention groups
1
Description
On the first day of hospitalization of this study, which will be performed non-blindly, patients of the intervention group will receive 40 mg subcutaneous adalimumab made by Sinagen factory. In the intervention group, as in the control group, adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol.
Category
Treatment - Drugs
2
Description
Control group: adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Mehrdad Farrokhnia
Street address
Afzalipour hospital, Emam khomeini Blvd.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
ah@kmu.ac.ir
Web page address
https://ah.kmu.ac.ir/en
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza MalekpourAfshar
Street address
Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
malekpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
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
Kerman University of Medical Sciences
Full name of responsible person
Mehrdad farrokhnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 8000
Email
Aha6765@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrdad farrokhnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Haft-Bagh Highway.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 8000
Email
Aha6765@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amir Hossein Arabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Haft-Bagh Highway.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 8000
Email
Aha6765@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available