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Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

Honduras

Study Type

Interventional

Intervention

Thymic peptides

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2 Infection, COVID-19 Pandemic, 2019 Novel Coronavirus Disease, Thymic peptides, Thymus gland, Peptides, Honduras, Coronavirus Disease 2019, Coronavirus Disease-19, COVID-19 Virus Infection, 2019-nCoV Disease, 2019-nCoV Infection

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed case of COVID-19 by viral nucleic acid (RNA) detection, viral antigen detection, or detection of antibodies to the virus.
Participants that require hospitalization under Honduran Ministry of Health Guidelines for Clinical Management of COVID-19 Adult Patients: Stage IIb, defined as a patient with or without risk factors that presents with warning signs (shortness of breath, tachypnea), and altered inflammatory parameters.
Participants that present with at least one of the following: oxygen saturation level below 94 percent; complete blood count showing lymphopenia, neutrophilia, or both; positive C-reactive protein; chest radiography or CT scan with ground-glass opacities.
Male or female at least 21 years old.

Exclusion Criteria:

COVID-19 patients that do not require hospitalization under Honduran Ministry of Health Guidelines for Clinical Management of COVID-19 Adult Patients: phase IA (asymptomatic), phase IB (mild symptoms without risk factors), or phase IC (mild symptoms with risk factors).
Participants currently in other clinical trials evaluating experimental drugs.
Known history of allergic reactions to thymic peptides or calf thymus acid lysate derivatives.
Organ transplant recipients.
Women who are pregnant or breast feeding.

Sites / Locations

Hospital de Santa Bárbara Integrado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daily oral dose of thymic peptides

Arm Description

Patients will receive a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment, for up to 20 days or until medical discharge.

Outcomes

Primary Outcome Measures

Time to Participant Recovery

Measured in days to clinical recovery that will be defined as the first day, during the 20 days after enrollment, on which a patient met the criteria for category 1, 2, or 3 on the eight-category ordinal scale. The categories are as follows: 1, not hospitalized and no limitations of activities; 2, not hospitalized, with limitation of activities, home oxygen requirement, or both; 3, hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care; 4, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to Covid-19 or to other medical conditions); 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 8, death.

Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0

Number of participants who experience adverse events ≥ Grade 3, as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects

Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE).

Secondary Outcome Measures

Number of Participants That Died by Day 20

Number of participants that died due to any reason by day 20.

Full Information

NCT ID

NCT04771013

First Posted

February 24, 2021

Last Updated

February 2, 2022

Sponsor

Universidad Católica de Honduras

Collaborators

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT04771013

Brief Title

Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras

Official Title

A Single-arm, Open-Label, Phase II Clinical Study to Evaluate the Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

February 10, 2021 (Actual)

Primary Completion Date

May 14, 2021 (Actual)

Study Completion Date

May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Católica de Honduras

Collaborators

Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a single-arm, open-label, phase II clinical study to evaluate the safety and efficacy of thymic peptides in the treatment of hospitalized COVID-19 patients in Honduras.

Detailed Description

This study was approved and registered by the Dirección General de Vigilancia del Marco Normativo de la Secretaría de Salud de Honduras (General Directorate for Regulatory Framework Surveillance of the Ministry of Health of Honduras) the eight of February of 2021; enrollment began tenth of February of 2021. The study will analyze 23 clinical parameters, 9 laboratory studies besides complete blood count, chest radiography, time to response, adverse clinical outcomes, and hospital length of stay in 22 participants treated with a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment. A participant-level comparison based on registry data from Hospital de Santa Bárbara Integrado will be performed after propensity score matching. The Generic Assessment of Side Effects in Clinical Trials (GASE) will be applied in addition to monitoring of treatment-emergent adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

SARS-CoV-2 Infection, COVID-19 Pandemic, 2019 Novel Coronavirus Disease, Thymic peptides, Thymus gland, Peptides, Honduras, Coronavirus Disease 2019, Coronavirus Disease-19, COVID-19 Virus Infection, 2019-nCoV Disease, 2019-nCoV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

A participant-level comparison based on registry data from the Hospital de Santa Bárbara Integrado will be performed after propensity score matching.

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daily oral dose of thymic peptides

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Thymic peptides

Other Intervention Name(s)

Unicahsina

Intervention Description

250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.

Primary Outcome Measure Information:

Title

Time to Participant Recovery

Description

Time Frame

During hospitalization for up to 20 days.

Title

Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0

Description

Number of participants who experience adverse events ≥ Grade 3, as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

Time Frame

Up to 20 days

Title

Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects

Description

Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE).

Time Frame

Up to 20 days

Secondary Outcome Measure Information:

Title

Number of Participants That Died by Day 20

Description

Number of participants that died due to any reason by day 20.

Time Frame

Up to 20 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed case of COVID-19 by viral nucleic acid (RNA) detection, viral antigen detection, or detection of antibodies to the virus. Participants that require hospitalization under Honduran Ministry of Health Guidelines for Clinical Management of COVID-19 Adult Patients: Stage IIb, defined as a patient with or without risk factors that presents with warning signs (shortness of breath, tachypnea), and altered inflammatory parameters. Participants that present with at least one of the following: oxygen saturation level below 94 percent; complete blood count showing lymphopenia, neutrophilia, or both; positive C-reactive protein; chest radiography or CT scan with ground-glass opacities. Male or female at least 21 years old. Exclusion Criteria: COVID-19 patients that do not require hospitalization under Honduran Ministry of Health Guidelines for Clinical Management of COVID-19 Adult Patients: phase IA (asymptomatic), phase IB (mild symptoms without risk factors), or phase IC (mild symptoms with risk factors). Participants currently in other clinical trials evaluating experimental drugs. Known history of allergic reactions to thymic peptides or calf thymus acid lysate derivatives. Organ transplant recipients. Women who are pregnant or breast feeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Héctor M Ramos, MD

Organizational Affiliation

Universidad Católica de Honduras; Pontificia Universidad Católica de Chile

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Karla G Reyes, MD

Organizational Affiliation

Universidad Católica de Honduras; Universidad Mayor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nelson A Espinoza, MD

Organizational Affiliation

Universidad Católica de Honduras

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Santa Bárbara Integrado

City

Santa Bárbara

ZIP/Postal Code

22101

Country

Honduras

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis.

Learn more about this trial

Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras

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