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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Héctor Miguel Ramos Zaldívar, Universidad Católica de Honduras

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Thymic peptides Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
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
Actual Study Start Date : February 10, 2021
Actual Primary Completion Date : May 14, 2021
Actual Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771013


Locations
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Honduras
Hospital de Santa Bárbara Integrado
Santa Bárbara, Honduras, 22101
Sponsors and Collaborators
Universidad Católica de Honduras
Pontificia Universidad Catolica de Chile
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Héctor Miguel Ramos Zaldívar, Universidad Católica de Honduras:
Study Protocol and Statistical Analysis Plan  [PDF] April 8, 2021

More Information
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Responsible Party: Héctor Miguel Ramos Zaldívar, Director of the Catholic University of Honduras Medical Research Group (GIMUNICAH), Universidad Católica de Honduras
ClinicalTrials.gov Identifier: 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 )
First Posted: February 25, 2021    Key Record Dates
Results First Posted: February 4, 2022
Last Update Posted: February 4, 2022
Last Verified: February 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Héctor Miguel Ramos Zaldívar, Universidad Católica de Honduras:
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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases