Protocol summary
-
Study aim
-
Evaluation of 50% reduction of viral load or negative results of virus before Day 7
-
Design
-
A phase III, Placebo-controlled, Paralleled, double-blind, randomized clinical trial
-
Settings and conduct
-
This is a randomized double blind study at Baqiyatallal Hospital and other centers of the study at hospitalized covid-19 patients. Nasal spray of interferon beta 1a will be prepared by sponsor of the study (CinnaGen), the package of the test and placebo drug will have totally equal shape and size. The drugs will be coded by randomization code which was prepared by an independent statistical person.
The dosage of the drug or placebo: One puff at each nostril, every 6 hours, for 7 days
-
Participants/Inclusion and exclusion criteria
-
Patients who have Covid-19 based on the CT-scan data or PCR and have no allergic sensitivity to the interferon products or participated in any other trials of Covid-19
-
Intervention groups
-
Test group:
Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc ..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days.
Control (Placebo) Group:
Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine, etc .), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days.
-
Main outcome variables
-
The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before Day 7
General information
-
Reason for update
-
Due to the primary endpoint change, the protocol is updated
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200511047396N1
Registration date:
2020-05-16, 1399/02/27
Registration timing:
prospective
Last update:
2020-06-28, 1399/04/08
Update count:
1
-
Registration date
-
2020-05-16, 1399/02/27
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-06-30, 1399/04/10
-
Expected recruitment end date
-
2020-11-21, 1399/09/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients
-
Public title
-
Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients who have Covid-19 based on the CT-scan or RT-PCR findings
Hospitalized patients
Willingness to participate in the study for trial period and signing the informed consent form
Age between 20-65
Exclusion criteria:
Pregnancy
Breastfeeding
Use of ARB/ACEi
History of hypotension
have no consent to participate in the study
Allergic sensitivity to the interferon products
Not availability of phone number or it is possible to be transferred to other hospitals
Having the CKD or patients who need dialysis at the begining of the study
Having any disease or condition that based on the physician judgment cannot participate in the study
Participation in any other trials of Covid-19
-
Age
-
From 20 years old to 65 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
50
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Block randomization (block sizes of 4) will be used to allocate drug or placebo to the patients of the study. Test drug or placebo will have randomization code which is specific for each patient and was generated by the randomization process. Randomization will not be exposed to the trial executers and will be provided to the investigator in non-transparent sealed envelopes.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Test drug and placebo are totally similar and have same color, shape, and size and is not distinguishable by patients or investigators
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-05-02, 1399/02/13
-
Ethics committee reference number
-
IR.BMSU.REC.1399.122
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
-
The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before day 7
-
Timepoint
-
before drug administration, day 3, day 5, and day 7 (before negative result until day 7)
-
Method of measurement
-
RT-PCR test
Secondary outcomes
1
-
Description
-
Number of days with fever (more than 37.2) up to 7 days
-
Timepoint
-
Daily up to day 7
-
Method of measurement
-
Thermometer
2
-
Description
-
Number of days with dyspnea until day 7
-
Timepoint
-
Daily up to day 7
-
Method of measurement
-
Clinical examination by investigator or history review of the patients
3
-
Description
-
Number of days that patients need supplemental oxygenation up to day 7
-
Timepoint
-
Daily up to day 7
-
Method of measurement
-
Examination by investigator
4
-
Description
-
Change of laboratory results of patients before treatment and last day of study (day 7)
-
Timepoint
-
Before drug administration and last day of study
-
Method of measurement
-
Laboratory results
5
-
Description
-
Adverse events
-
Timepoint
-
Daily up to day 7
-
Method of measurement
-
Investigator report
6
-
Description
-
Number of days that patients have dry cough
-
Timepoint
-
Daily until day 7
-
Method of measurement
-
Examination by investigator
Intervention groups
1
-
Description
-
Intervention group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff (equall to 1000 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Concomitant with the national corona treatment recommendation (based on the Ministry of Health protocol: hydroxychloroquine etc,..), patients will receive 1 puff of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 7 days
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
CinnaGen company
-
Proportion provided by this source
-
100
-
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
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
-
Not applicable
-
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