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

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

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 20 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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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.

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


Contacts
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Contact: Héctor M Ramos, MD +56934988958 hramos@unicah.edu

Locations
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Honduras
Hospital de Santa Bárbara Integrado Recruiting
Santa Bárbara, Honduras, 22101
Contact: Héctor M Ramos, MD    +56934988958    hramos@unicah.edu   
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
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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
Last Update Posted: February 25, 2021
Last Verified: February 2021
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