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

• ClinicalTrials.gov Identifier: NCT04771013
• Recruitment Status: Completed
• First Posted: February 25, 2021
• Results First Posted: February 4, 2022
• Last Update Posted: February 4, 2022
• Sponsor: Universidad Católica de Honduras
• Collaborator: Pontificia Universidad Catolica de Chile
• Information provided by (Responsible Party): Héctor Miguel Ramos Zaldívar, Universidad Católica de Honduras

Tracking Information

• First Submitted Date: February 24, 2021
• First Posted Date: February 25, 2021
• Results First Submitted Date: January 13, 2022
• Results First Posted Date: February 4, 2022
• Last Update Posted Date: February 4, 2022
• Actual Study Start Date: February 10, 2021
• Actual Primary Completion Date: May 14, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2022)

• Time to Participant Recovery [ Time Frame: During hospitalization for up to 20 days. ]
  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 [ Time Frame: Up to 20 days ]
  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 [ Time Frame: Up to 20 days ]
  Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE).

Original Primary Outcome Measures (submitted: February 24, 2021)

• Time to Participant Response [ Time Frame: During hospitalization for up to 20 days. ]
  Measured in days to clinical response that will be defined as clinical stability (temperature, ≤37.8°C; heart rate, ≤100 beats per min; systolic blood pressure, ≥90 mm Hg; respiratory rate, ≤24 breaths per min; oxygen saturation, ≥90 percent; normal mental status; no receipt of supplemental oxygen by face mask or mechanical ventilation) with improvement in at least one symptom (anosmia, dysgeusia, cough, shortness of breath, cyanosis, conjunctivitis, pharyngitis, sputum production, rhinorrhea, myalgia, otalgia, odynophagia, fatigue, diarrhea, hemoptysis, vomit) and with no symptom worsening that is sustained for at least 24 h.
• Number of Participants with Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) [ Time Frame: Up to 20 days ]
  Number of participants who experience adverse events ≥ Grade 3, as defined by the CTCAE v5.0.
• Number of Participants with Treatment Related Side Effects as Assessed by the General Assessment of Side Effects (GASE) [ Time Frame: Up to 20 days ]
  Number of participants who experience severe side effects as defined by the GASE.

Current Secondary Outcome Measures (submitted: February 2, 2022)

Number of Participants That Died by Day 20 [ Time Frame: Up to 20 days ]

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

Original Secondary Outcome Measures (submitted: February 24, 2021)

• Hospital Average Length of Stay (ALOS) as Measured by the Mean Participants' Inpatient Days [ Time Frame: Up to 20 days ]
  The average length of stay will be calculated by dividing the sum of inpatient days by the number of participant admissions.
• Overall Survival Defined as the Time From the Start of Treatment until Death due to any Reason [ Time Frame: Up to 20 days ]
  Time for overall survival will be measured in days.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: 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.

Other Name: Unicahsina

Study Arms

Experimental: Daily oral dose of thymic peptides

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.

Intervention: Biological: Thymic peptides

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 14, 2021): 22
• Original Estimated Enrollment (submitted: February 24, 2021): 20
• Actual Study Completion Date: May 14, 2021
• Actual Primary Completion Date: May 14, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Honduras

Administrative Information

• NCT Number: NCT04771013
• Other Study ID Numbers: AEC-01-2021; COM-2020-01 ( Other Identifier: Catholic University of Honduras IRB in Tegucigalpa ); AEC-01-2021 ( Registry Identifier: Dirección General de Vigilancia del Marco Normativo Honduras )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All of the individual participant data collected during the trial, after deidentification.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: Beginning 3 months and ending 5 years following article publication.

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.

• Current Responsible Party: Héctor Miguel Ramos Zaldívar, Universidad Católica de Honduras
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Católica de Honduras
• Original Study Sponsor: Same as current
• Collaborators: Pontificia Universidad Catolica de Chile

Investigators

• Study Director: Héctor M Ramos, MD; Universidad Católica de Honduras; Pontificia Universidad Católica de Chile
• Principal Investigator: Karla G Reyes, MD; Universidad Católica de Honduras; Universidad Mayor
• Principal Investigator: Nelson A Espinoza, MD; Universidad Católica de Honduras

• PRS Account: Universidad Católica de Honduras
• Verification Date: February 2022