View older revisions Content changed at 2020-08-17, 1399/05/27

Protocol summary

Study aim
This study aims to investigate the effect of recombinant erythropoietin on the recovery process of COVID-19 patients.
Design
Concealed, randomized, single blinded, phase 2 controlled clinical trial with two arm parallel group design of 20 patients, using the placebo in the control group.
Settings and conduct
This study will be performed at Shahid Mohammadi Hospital in Bandar Abbas. Patients enter the study after obtaining written consent, but will not know which group they belong to.
Participants/Inclusion and exclusion criteria
All positive COVID-19 patients who have Hb≤9 and at least one of the severe COVID-19 symptoms and are willing to cooperate in this project will be included in the study. Patients with a history of coronary heart disease, thrombosis, deep vein thrombosis, chronic lung disease, diabetes mellitus, weakened immune system, end stage renal disease, liver disease, and patients with a history of taking oral contraceptive pills, systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 90 mm Hg and age over 65 and erythropoietin above 500 are excluded.
Intervention groups
Patients are divided into two groups. In group A, the standard treatment for COVID-19 patients with recombinant erythropoietin is prescribed. In group B, patients receive standard COVID-19 treatment with the placebo.
Main outcome variables
Patient clinical symptoms, Laboratory examinations of patients and Hemoglobin

General information

Reason for update
Due to the decrease in the number of COVID-19 patients referring to our center and the results of studies that show a non-significant effect of sex factor on the severity of COVID-19, random allocation of patients have not been stratified according to gender. Due to the prevention of possible drug side effects, the dose of the intervention drug was reduced from 5 times a day to 3 times a day. The placebo dose was also reduced by the same amount.
Acronym
IRCT registration information
IRCT registration number: IRCT20200509047364N1
Registration date: 2020-08-09, 1399/05/19
Registration timing: registered_while_recruiting

Last update: 2020-08-17, 1399/05/27
Update count: 1
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Dariush Hooshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3670 3778
Email address
dariush.hooshyar@hums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of recombinant erythropoietin on the improvement of COVID-19 patients
Public title
Effect of erythropoietin on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All definitively positive COVID-19 patients with Hb≤9. Having at least one of the severe symptoms of COVID-19, including tachypnea (breathing rate> 30 beats per minute), hypoxemia (O2 ≤93 saturation, the partial pressure ratio of arterial oxygen <300), Lung infiltration (> 50% of lung field within 24 to 48 hours), progressive lymphopenia, LDH>245 U/I, CRP>100
Exclusion criteria:
Patients with a history of coagulopathy Patients with a history of thrombosis Patients with a history of deep vein thrombosis Patients with a history of chronic lung disease Patients with a history of diabetes mellitus Patients with weakened immune systems Patients with a history of end stage renal disease Patients with liver disease Patients with a history of taking oral contraceptive pills (OCPs) Patients with systolic blood pressure greater than 160 mmHg Patients with diastolic blood pressure greater than 90 mmHg Patients over 65 years of age Patients with erythropoietin above 500 Patients with a history of myocardial infarction or unstable angina Patients with a history of malignancy
Age
To 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification. eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all participants are aware of participating in this study and enter the study with their consent. All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive recombinant erythropoietin in the treatment group and receive a placebo in the control group. The lead researcher, health care personnel, data collection officials, and those who evaluate the outcome are aware of the grouping of patients. Those who prepare the draft of the article are unaware of the groupings if they do not cooperate in the above cases.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
City
bandar abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.HUMS.REC.1399.165

Health conditions studied

1

Description of health condition studied
Laboratory confirmed COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Respiratory rate
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pulse Oximeter

2

Description
Oxygen saturation state and arterial oxygen partial pressure ratio
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pulse Oximeter

3

Description
Lung infiltration status
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Chest X-ray

4

Description
LDH level's
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pathobiology laboratory

5

Description
CRP level's
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pathobiology laboratory

6

Description
Lymphocyte count
Timepoint
At the beginning of the study (before the intervention) and day 5 after the intervention
Method of measurement
Pathobiology laboratory

7

Description
Endogenous erythropoietin level's
Timepoint
Beginning of study (before intervention)
Method of measurement
Pathobiology laboratory

8

Description
Patients' blood pressure
Timepoint
At the beginning of the study (before the intervention), during the intervention (5-day erythropoietin administration)
Method of measurement
Sphygmomanometer

Secondary outcomes

1

Description
Patients' blood hemoglobin levels
Timepoint
Start of study (before the intervention), day 5 after the intervention and 2 to 4 weeks after the intervention
Method of measurement
Pathobiology laboratory

Intervention groups

1

Description
Intervention group: Group A.: The standard drug treatment is based on the treatment protocols of the National Committee of COVID-19 and erythropoietin recombinant (EPREX Manufactured by Johnson and Johnson Pharmaceutical Company) 300 units / Kg or 4000IU as subcutaneous injection three times a day for 5 days and simultaneously Enoxaparin 1mg / kg SQ daily is also taken to prevent thrombosis. Patients' blood pressure, along with other vital signs, is checked regularly and at regular intervals. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Atazanavir / Ritonavir tablets (300mg/100mg), One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
Category
Treatment - Drugs

2

Description
Control group: Group B: The standard drug treatment is based on the treatment protocols of the National Committee for COVID-19 and the placebo(distilled water) is given as a subcutaneous injection three times a day for 5 days. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Atazanavir / Ritonavir tablets (300mg/100mg), One tablet daily with food or Atazanavir 400 mg daily for at least 7 days, and up to 14 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr. Mehdi Hassaniazad
Street address
Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teamur Aghamolaei
Street address
Deputy of Research and Technology, Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
research@hums.ac.ir
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dariush Hooshyar
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 990 038 7226
Email
dariush.hooshyar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Mitra Kazemijahromi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 791 2820
Email
mitra.kazemijahromi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Mitra Kazemijahromi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Office of the Subspecialty Internal Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 791 2820
Email
mitra.kazemijahromi@gmail.com

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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...