Revisions for Expanded Clinical Use of Nasalferon in COVID-19 | Registro Público Cubano de Ensayos Clínicos

--- 10 November 2021 - 6:06pm by Gladys
+++ 19 July 2023 - 4:28pm by Gladys
-/11/10
+/03/31
-/11/10
+/03/31

Revision of 19 July 2023 - 4:28pm:

Expanded Clinical Use of Nasalferon in COVID-19

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

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

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:

Click here

Registered Trials

Registration process

Expanded Clinical Use of Nasalferon in COVID-19

About the RPCEC

Useful resources