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Evaluation of the effects of epinephrine on the treatment of COVID-19 pneumonia: a randomized clinical trial

Protocol summary

Study aim
Evaluation of the effect of nebulized and endotracheal epinephrine in the treatment of Covid-19 pneumonia
Design
A phase 2-3, placebo-controlled, paralleled, single-blind, randomized clinical trial, 84 patients
Settings and conduct
This study will be conducted at the Shahid Mohammadi Hospital and Khalij e Fars Hospital, Hormozgan, Bandar Abbas. The study population is 84 patients with COVID-19 (42 patients in treatment group and 42 in placebo group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 80 years, Positive polymerase chain reaction (PCR) test for COVID-19, Hospitalized, and Signing informed consent and willingness of study participant to accept randomization to any assigned treatment. Exclusion criteria: Contraindications epinephrine including, hemorrhagic CVA, TIA, and acute MI, Heart rate > 100, History of allergy to epinephrine, Pregnancy, and breastfeeding.
Intervention groups
Treatment group will receive the intratracheal epinephrine for intubated patients, and nebulizer form of epinephrine for non-intubated patients at a dose of 200 micrograms three times a day for five days, in addition to the standard treatment. Placebo group will receive distilled water for intubated patients and non-intubated patients at a same volume three times a day for five days, in addition to the standard treatment.
Main outcome variables
Checking the clinical symptoms, O2 saturation, Evaluation of pulmonary imaging, Occurrence of adverse drug reactions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200506047323N8
Registration date: 2021-05-24, 1400/03/03
Registration timing: prospective

Last update: 2021-05-24, 1400/03/03
Update count: 0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
Mohammad Fathalipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0406
Email address
m.fathalipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of epinephrine on the treatment of COVID-19 pneumonia: a randomized clinical trial
Public title
epinephrine in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 80 years Positive polymerase chain reaction (PCR) test for COVID-19 Hospitalized Signing informed consent and willingness of study participant to accept randomization to any assigned treatment a
Exclusion criteria:
Contraindications epinephrine including, hemorrhagic CVA, TIA, and acute MI Heart rate > 100 History of allergy to epinephrine Pregnancy and breastfeeding
Age
From 18 years old to 80 months old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be performed (each block consists 6 patients). Allocation sequence and concealment codes will be generated using www.sealedenvelope.com. The closed envelope method will be used to hide the allocation sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
The epinephrine and placebo will be coded by the project manager. Patients will be randomly allocated within the blocks based on the hidden codes. Only study participants will be blind to the intervention and studied groups. However, physicians and nurses who evaluate the outcomes will be aware of the codes.‎
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
Jomhuri Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.HUMS.REC.1399.488

Health conditions studied

1

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

Primary outcomes

1

Description
Clinical symptoms
Timepoint
Before intervention and daily during the study
Method of measurement
Questionnaire

2

Description
Oxygen saturation
Timepoint
Before intervention and daily during the study
Method of measurement
Pulse oximeter

3

Description
Pulmonary imaging finding
Timepoint
Before intervention and the fifth day of the study
Method of measurement
Computed tomography

Secondary outcomes

1

Description
Incidence of serious adverse events
Timepoint
Before intervention and daily during the study
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: The standard treatment for COVID-19 based on the Ministry of Health's protocol plus intratracheal epinephrine for intubated patients, and nebulizer form of epinephrine for non-intubated patients at a dose of 200 micrograms three times a day for five days.
Category
Treatment - Drugs

2

Description
Control group: The standard treatment for COVID-19 based on the Ministry of Health's protocol plus intratracheal or nebulizer distilled water at a same volume three times a day for five days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Parivash Davoodian
Street address
Jomhuri Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Web page address
http://shmh.hums.ac.ir/

2

Recruitment center
Name of recruitment center
Khalij e Fars Hospital
Full name of responsible person
Bibi Mona Razavi
Street address
Pardis Blve
City
Bandar Abbas
Province
Hormozgan
Postal code
7681964396
Phone
+98 76 3367 0280
Fax
+98 76 3367 0280
Email
razavi.b.m.1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Jomhuri Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 3280
Fax
+98 76 3334 6994
Email
mail@hums.ac.ir
Web page address
http://hums.ac.ir/
Grant name
Grant code / Reference number
990551
Is the source of funding the same sponsor organization/entity?
No
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
Parivash Davoodian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Jomhuri Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 3280
Email
parivash.davoodian@hums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Parivash Davoodian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Jomhuri Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 3280
Email
parivash.davoodian@hums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Fathalipour
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
خیابان اتوبوسرانیُ کوچه ایثار ۲ُ ساختمان محترم ۴ُ طبقه ۶ُ واحد ۶۰۳
City
بندرعباس
Province
Hormozgan
Postal code
7915879833
Phone
+98 76 3371 0406
Fax
+98 76 3371 0389
Email
m.fathalipour@hums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information regarding the study outcomes will be shared
When the data will become available and for how long
Data will become available after publication of obtained results
To whom data/document is available
Only academic institutions
Under which criteria data/document could be used
The study protocol or proposal should be approved by Ethics committee of institutions. The rights of authors and sponsors should be respected.
From where data/document is obtainable
M.fathalipour@yahoo.com
What processes are involved for a request to access data/document
Requests should be addressed to the Technology and Research Vice-chancellery of Hormozgan University of Medical Sciences and the project executor should informed
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