Protocol summary
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Study aim
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Evaluation of the effectiveness of inhaled formoterol to improve respiratory symptoms of COVID 19 patients.
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Design
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The randomized clinical trial with two parallel groups; without blinding, in which 200 patients will be enrolled between 18 April 2020 till 19 June 2020
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Settings and conduct
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200 eligible patients will be divided into two groups by simple randomization.
Patients in the Formoterol group will receive one dose of inhaled formoterol twice daily for 10 days along with the national protocol for COVID-19.
Disease duration, the mortality rate, and the rate of symptom improvement at the 5th and 10th day based on Complete improvement, Partial improvement, lack of improvement and admission, will be assessed for 30 days.
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Participants/Inclusion and exclusion criteria
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-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.
In the case of Pregnancy, Comorbidity, Saturation less than 93% or any criteria for hospitalization, History of formoterol intolerance, Cardiac diseases, such as heart failure or arrhythmia, Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors, Asthma or a history of Chronic obstructive pulmonary disease (COPD), Heavy smoking, the patient will be excluded.
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Intervention groups
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1- Inhaled Formoterol
In this group along with the national regiment according to the national guideline of treatment for COVID-19, patients will take Formoterol (made by Medochemie ) one Puff every 12 hours, for 10 days.
2- Control group: receive national regimen for COVID-19 according to national protocol.
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Main outcome variables
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five-day symptom improvement;
10-day symptom improvement;
Total time since randomization until clinical improvement.
General information
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Reason for update
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For the title, respiratory symptoms were considered, thus, the title was revised.
During the Implementation of the trial, exclusion criteria were expanded; so, this part of the protocol was amended. Some exclusion criteria such as asthma and cardiac disease were added.
The sample size was increased to have more similarity in baseline characteristics in treatment and control groups. In each arm. 100 participants were considered.
The trial was multicenter, so all recruit centers were added.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170210032478N3
Registration date:
2020-04-29, 1399/02/10
Registration timing:
registered_while_recruiting
Last update:
2021-01-02, 1399/10/13
Update count:
1
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Registration date
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2020-04-29, 1399/02/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-18, 1399/01/30
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Expected recruitment end date
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2020-06-19, 1399/03/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The efficacy of inhaled formoterol on symptom improvement in covid 19 patients
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Public title
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Effect of Formoterol in treatment of covid19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 7 days
History of formoterol intolerance
cardiac diseases, such as heart failure or arrhythmia
Recent history of using inhaled corticosteroids, bronchodilators, and ACE inhibitors
Asthma or COPD
Heavy Smoker
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using even and odd numbers, the patients are simply randomized and placed in two groups of intervention and (no- intervention).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-10, 1398/12/20
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Ethics committee reference number
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IR.SBMU.NRITLD.REC.1399.003
Health conditions studied
1
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Description of health condition studied
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corona virus or COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
2
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Description of health condition studied
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COVID 19 ,virus not identified
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ICD-10 code
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U07.2
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ICD-10 code description
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COVID-19, virus not identified
Primary outcomes
1
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Description
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Level of Improvement
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Timepoint
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the 5th and 10th days
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Method of measurement
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clinical evaluation, observation, physical examination, and call interview for follow up
Secondary outcomes
1
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Description
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Total time to improvement
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Timepoint
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up to 30 days follow-up
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Method of measurement
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observation
Intervention groups
1
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Description
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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 10 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: standard treatment according to protocol
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Research Institute of Tuberculosis and Lung Diseases
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Medochemie KSN
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable