History
# Registration date Revision Id
2 2020-11-24, 1399/09/04 165776
1 2020-04-29, 1399/02/10 131786
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Evaluation of the effectiveness of inhaled formoterol to improve respiratory symptoms of COVID 19 patients.
Design
The randomized clinical trial with two parallel groups in which 100 patients will be enrolled between 18 April 2020 till 19 June 2020
Settings and conduct
This study will be performed at Masih Daneshvari Hospital, Tehran, Iran. In this study, 100 patients will be enrolled based on inclusion and exclusion criteria and divided into two groups (50 in each group) by simple randomization. Patients in the control group will receive a standard regimen for COVID-19. Patients in the Formoterol group will receive one dose of inhaled formoterol drug twice daily for two weeks along with the standard regimen for COVID-19. The routine lab data, disease duration, and mortality rate will be assessed in both groups.
Participants/Inclusion and exclusion criteria
-Patients aged 18 to 75 years old -Both Sexes -COVID-19 patients based on clinical manifestations or according to CBC, CRP, and Chest radiography or other lab tests -patients who voluntarily agree to participate in the study after being fully informed about it and sign the consent form.
Intervention groups
1- Inhaled Formoterol In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol (made by Medochemie ) one Puff every 12 hours, for 7 days. 2- Control group: receive standard regimen for COVID-19 according to national protocol.
Main outcome variables
Recovery of Pneumonia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170210032478N3
Registration date: 2020-04-29, 1399/02/10
Registration timing: registered_while_recruiting

Last update: 2020-04-29, 1399/02/10
Update count: 1
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2163
Email address
dr.f.ghorbani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of inhaled formoterol on symptom improvement in covid 19 patients
Public title
Effect of Formoterol in treatment of covid19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(COVID-19) with according to the clinical manifestations confirmed with CBC, CRP, and Chest radiography or other lab tests Patients who voluntarily sign our consent form.
Exclusion criteria:
Pregnancy Comorbidity Saturation less than 93% The presence of symptoms for more than 2 days
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Using even and odd numbers, the patients are simply randomized and placed in two groups of intervention and (no- intervention).
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 National Research Institute of Tuberculosis and Lung Diseases
Street address
Niavaran, Daaraabaad
City
Tehran
Province
Tehran
Postal code
1956744413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1398.003

Health conditions studied

1

Description of health condition studied
corona virus or COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Time to Clinical Improvement
Timepoint
1, 2, 3 weeks
Method of measurement
call interview follow up

2

Description
Relapse and re visiting
Timepoint
10 days
Method of measurement
observation

Secondary outcomes

1

Description
Percentage of convert CRP to negative in case of positive ones
Timepoint
14 days
Method of measurement
lab test

2

Description
correction of Lymphopenia
Timepoint
14 days
Method of measurement
lab test

Intervention groups

1

Description
Intervention group: Inhaled Formoterol، In this group along with the standard regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol 1 Puff every 12 hours made by Medochemie Company for 7 days.
Category
Treatment - Drugs

2

Description
Control group: standard treatment according to protocol
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Giti Pourdoulat
Street address
Daaraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Fax
+98 21 2610 5387
Email
pourdowlat_g@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Parisa Farnia
Street address
Daaraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2009
Email
tdrc.nritld@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
pharmacy
Proportion provided by this source
50
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
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Fariba Ghorbani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 1,Daraabaad Ave., Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Email
dr.f.ghorbani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Guitti Pourdowlat
Position
Assistant Proffessore
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonologyst
Street address
Niavaran, Daraabaad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Email
pourdowlat_g@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Fariba Ghorbani
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Daraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956744413
Phone
+98 21 2712 2163
Email
dr.f.ghorbani@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
Not applicable
Data Dictionary
Not applicable
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