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Expanded Clinical Use of Nasalferon in COVID-19
Updated by CIGB on 19/07/2023 - 4:28pm
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General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
PUCE Nasalferon
Scientific title:
Intranasal use of recombinant human interferon alfa-2b in the treatment of asymptomatic and mild symptomatic low-risk patients with suspected and confirmed COVID-19. (COVID-19)
Acronym of Scientific Title:
NASALFERON-SNS
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center for Genetic Engineering and Biotechnology (CIGB)
Secondary sponsor:
Ministry of Public Health (MINSAP)
Source(s) of monetary or material support:
Ministry of Public Health (MINSAP)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Reference number:
In process
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Daniel
Last name:
Gonzalez Rubio
Medical Specialty :
Second Degree Specialist in Internal Medicine
Affiliation:
Pedro Kouri Institute of Tropical Medicine
Postal address:
Avenida Novia del Mediodia, KM 6 1/2, La Lisa
City:
Havana
Country:
Cuba
Zip Code:
11400
Telephone:
+53-72020425
Email address:
instituto@ipk.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
15/11/2021
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
COVID-19
Health condition(s) code:
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Nidovirales Infections
Betacoronavirus
Health condition keyword:
COVID-19
SARS-CoV-2
Intervention(s):
Nasalferon: Recombinant human interferon alpha 2b solution for nasal administration (Nasalferon) with strength of 5 million international units per milliliter. Dosage: one drop in each nostril twice a day for 10 consecutive days
Intervention code:
Interferon alpha-2
Interferon alpha
Interferons
Administration, Intranasal
Intervention keyword:
Nasalferon, drops
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Occurrence of adverse events associated with treatment (Yes or No, Description of adverse events). Measurement time: daily during the patient's treatment time (10 days).
Key secondary outcomes:
1. Intensity of the adverse event (CLasified as mild, moderate or severe). Measurement time: daily during the patient's treatment times (10 days). 2. Causation of the adverse event (Classified as definitive, probable, possible and doubtful). Measurement time: daily during the patient's treatment times (10 days). 3. Severity of the adverse event (classified as serious and non-serious). Measurement time: daily during the patient's treatment times (10 days).
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
10 years
Maximum age:
80 years
Inclusion criteria:
1. Low risk suspect, mild symptomatic, with positive antigen test. 2. Confirmed low risk, asymptomatic and mild symptomatic, with positive PCR. 3. Voluntariness of the patient or legal representative.
Exclusion criteria:
1. Individuals confirmed COVID-19 and classified as medium and high risk. 2. Individuals with hypersensitivity to thiomersal (thimerosal). 3. Individuals with hypersensitivity to interferon alpha
Type of population:
Children and Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Single group
Phase:
N/A
Target sample size:
200
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Hugo
Last Name:
Nodarse Cuni
Specialty:
Doctor in Pharmaceutical Sciences. Monitor responsible for the Clinical Trial
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB).
Postal Address:
Ave 31 e/t 158 y 190. Cubanacan. Playa
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72080428 ext 107
Email :
hugo.nodarse@cigb.edu.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Hugo
Last Name:
Nodarse Cuni
Specialty:
Doctor in Pharmaceutical Sciences. Monitor responsible for the Clinical Trial
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB).
Postal Address:
Ave 31 e/t 158 y 190. Cubanacan. Playa
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72080428 ext 107
Email :
hugo.nodarse@cigb.edu.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Pedro Kouri Institute of Tropical Medicine
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
12/10/2021
Postal address of Ethic Committee :
Av. Novia del Mediodia, KM 6 1/2, La Lisa, Havana, ZC 11400, Cuba
Telephone:
+53-72020425
Email:
instituto@ipk.sld.cu
About study completion
Section to complete the data related to the study completion.
Study completion date:
10/01/2022
Date of available results:
31/01/2022
Date of first publication:
31/03/2022
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000396
Date of Registration in Primary Registry:
10/11/2021
Record Verification Date:
2022/03/31
Next update date:
2023/03/31
Link to the spanish version:
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