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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771013
• Other study ID #: AEC-01-2021
• Secondary ID: COM-2020-01AEC-0
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2021
• Est. completion date: May 14, 2021

Study information

• Verified date: February 2022
• Source: Universidad Católica de Honduras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Honduras	Hospital de Santa Bárbara Integrado	Santa Bárbara

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Católica de Honduras	Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During hospitalization for up to 20 days.
Primary	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).	Up to 20 days
Primary	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).	Up to 20 days
Secondary	Number of Participants That Died by Day 20	Number of participants that died due to any reason by day 20.	Up to 20 days