Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras
NCT ID: NCT04771013
Last Updated: 2022-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2021-02-10
2021-05-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Thymic peptides
250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.
Interventions
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Thymic peptides
250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Universidad Católica de Honduras
OTHER
Responsible Party
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Héctor Miguel Ramos Zaldívar
Director of the Catholic University of Honduras Medical Research Group (GIMUNICAH)
Principal Investigators
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Héctor M Ramos, MD
Role: STUDY_DIRECTOR
Universidad Católica de Honduras; Pontificia Universidad Católica de Chile
Karla G Reyes, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica de Honduras; Universidad Mayor
Nelson A Espinoza, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica de Honduras
Locations
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Hospital de Santa Bárbara Integrado
Santa Bárbara, , Honduras
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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COM-2020-01
Identifier Type: OTHER
Identifier Source: secondary_id
AEC-01-2021
Identifier Type: REGISTRY
Identifier Source: secondary_id
AEC-01-2021
Identifier Type: -
Identifier Source: org_study_id
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