Clinical trial NCT04771013: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Universidad Católica de Honduras
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
First posted: 2021-02-25
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A participant-level comparison based on registry data from the Hospital de Santa Bárbara Integrado will be performed after propensity score matching.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Participant Recovery
timeFrame: During hospitalization for up to 20 days.
measure: Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0
timeFrame: Up to 20 days
measure: Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects
timeFrame: Up to 20 days
Secondary outcomes:
measure: Number of Participants That Died by Day 20
timeFrame: Up to 20 days
Other outcomes:
Locations:
city: Santa Bárbara
country: Honduras
facility: Hospital de Santa Bárbara Integrado
Study officials:
affiliation: Universidad Católica de Honduras; Pontificia Universidad Católica de Chile
name: Héctor M Ramos, MD
role: STUDY_DIRECTOR
affiliation: Universidad Católica de Honduras; Universidad Mayor
name: Karla G Reyes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica de Honduras
name: Nelson A Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
References: