Revisions for Nasalferon in COVID-19 | Registro Público Cubano de Ensayos Clínicos

--- 12 November 2021 - 1:08pm by Gladys
+++ 6 July 2022 - 12:20pm by CIGB
-Pending
+Suspended
-/11/12
+/07/06
-/11/12
+/07/06

Revision of 6 July 2022 - 12:20pm:

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:

NASALFERON

Scientific title:

Intranasal use of recombinant human interferon alfa-2b in the treatment of patients with mild-stage COVID-19. Randomized comparison 5M-10M placebo controlled. (COVID-19)

Acronym of Scientific Title:

NASALFERON-T

Secondary indentifying numbers:

IG/IAGN/CV/2102

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB)

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:

Madelayny

Last name:

Tamayo Rodriguez

Medical Specialty :

First Degree Specialist in Internal Medicine

Affiliation:

Central Military Hospital "Doctor Luis Díaz Soto"

Postal address:

Monumental Ave, Km. 2 ½. Habana del Este

City:

Havana

Country:

Cuba

Zip Code:

19130

Telephone:

+53-77680000

+53-77680057

Email address:

ismmds@infomed.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:

Suspended

Date of first enrollment:

22/11/2021

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):

Group 1, Nasalferon 5M (experimental): Recombinant human interferon alpha 2b solution for nasal administration (Nasalferon) of 5 million international units per milliliter (MIU/mL) in doses of one drop in each nostril twice daily for 10 consecutive days, Group 2, Nasalferon 10M (experimental): Nasalferon 10 MIU/mL in doses of one drop in each nostril twice a day for 10 consecutive days. Group 3, Placebo (control): Nasalferon Placebo in doses of 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):

Recovered patient (SARS-CoV-2 PCR negative in the absence of major symptoms of upper respiratory infection). Measurement time: on the 3rd day, 5th day, 7th day and 9th day after starting the treatment.

Key secondary outcomes:

1. Speed of response to treatment (Moment of first negative PCR during treatment). Measurement time: on the 3rd day, 5th day, 7th day and 9th day after starting the treatment. 2. Proportion of patients recovered (ratio of number of patients recovered / number of patients included). Measurement time: at hospital discharge. 3. Severity of the disease (Duration and intensity of COVID-19 symptoms). Measurement time: daily during the time of hospitalization of the patient.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

80 years

Inclusion criteria:

1. Virological diagnosis by RT-PCR of infection with SARS-CoV-2. 2. Age between 19 and 80 years, without distinction of sex or skin color. 3. Mild stage COVID-19 patients. 4. Time no longer than 48 hours from the onset of clinical respiratory symptoms. 5. Informed consent of the patient or legal representative

Exclusion criteria:

1. Individual with PCR positive for SARS-CoV-2 without having started treatment within 48 hours after the onset of symptoms. 2. Individuals under the age of 19 and over the age of 80. 3. Individuals with COVID-19 in moderate, severe or critical stage. 4. Individuals with decompensated chronic disease. 5. Immunosuppressant treatment in the last month prior to enrollment. 6. Ongoing treatment, for any cause, with any IFN formulation. 7. Use of any other medication or substance intranasally. 8. Patients with myasthenia gravis. 9. Administration of an investigational drug in the 30 days prior to inclusion in the study. 10. Individuals with hypersensitivity to thiomersal (thimerosal). 11. Individuals with hypersensitivity to interferon alpha. 12. Obvious mental incapacity to give consent and act accordingly with the study. 13. Pregnancy, puerperium or lactation

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

128

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. Clinical trial advisor

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. Clinical trial advisor

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:

Central Military Hospital "Doctor Luis Diaz Soto"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

22/10/2021

Postal address of Ethic Committee :

Av. Monumental km 2 ½ . ZC 19130. Habana del Este, Havana. Cuba

Telephone:

+53-77680000

Email:

ismmds@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/12/2021

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:

RPCEC00000399

Date of Registration in Primary Registry:

12/11/2021

Record Verification Date:

2022/07/06

Next update date:

2023/07/06

Link to the spanish version:

Click here

Registered Trials

Registration process

Nasalferon in COVID-19

About the RPCEC

Useful resources