Comparing efficacy of interferon beta 1a nasal spray and placebo for Time to Clinical Recovery of Covid-19 (Fever normalization and oxygen saturation sustained for at least 72 hours)
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 at mild to moderate cases of covid-19. 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 14 days
Participants/Inclusion and exclusion criteria
Patients who have mild to moderate Covid-19 based on the CT-scan data 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 14 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 14 days.
Main outcome variables
The primary outcome was defined as the Time to Clinical recovery (TTCR), up to 14 days. TTCR is further defined as the time (in hours) from initiation of study treatment (active or placebo) until normalization of fever, and oxygen saturation sustained for at least 72 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200511047396N1
Registration date:2020-05-16, 1399/02/27
Registration timing:prospective
Last update:2020-05-16, 1399/02/27
Update count:1
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
Ramin Ajdarzade
Name of organization / entity
CinnaGen
Country
Iran (Islamic Republic of)
Phone
+98 26 3667 0734
Email address
azhdarzadehm@cinnagen.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
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 Mild to Moderate cases of Covid-19 at Baqiyatallal Hospital
Public title
Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in Mild to Moderate cases of Covid-19 at Baqiyatallal Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have Covid-19 based on the CT-scan findings
Mild to moderate cases of Covid-19
Willingness to participate in the study for trial period and signing the informed consent form
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
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bagiyatollah University of Medical Sciences
Street address
Bagiyatollah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
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 defined as the Time to Clinical recovery (TTCR), up to 14 days. TTCR is further defined as the time (in hours) from initiation of study treatment (active or placebo) until normalization of fever, and oxygen saturation sustained for at least 72 hours
Timepoint
before drug administration, daily up to day 14
Method of measurement
Thermometer (for fever) and pulse oximeter for oxygen saturation
Secondary outcomes
1
Description
Number of days with fever (more than 37.2) up to 14 days
Timepoint
Daily up to day 14
Method of measurement
Thermometer
2
Description
Number of days with dyspnea until day 14
Timepoint
Daily up to day 14
Method of measurement
Clinical examination by investigator or history review of the patients
3
Description
Number of days that patients need mechanical ventilation up to day 14
Timepoint
Daily up to day 14
Method of measurement
Examination by investigator
4
Description
Number of days that patients need supplemental oxygenation up to day 14
Timepoint
Daily up to day 14
Method of measurement
Examination by investigator
5
Description
Number of hospitalization day
Timepoint
Daily up to day 14
Method of measurement
Recorded checklist by investigator
6
Description
Number of death
Timepoint
Daily up to day 14
Method of measurement
Investigator report
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 100 IU of interferon beta 1a)of a nasal spray (CinnaGen Company) at each nostril, every 6 hours for 14 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 14 days