Status:
COMPLETED
Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras
Lead Sponsor:
Universidad Católica de Honduras
Collaborating Sponsors:
Pontificia Universidad Catolica de Chile
Conditions:
COVID-19
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04771013
Start Date
February 10 2021
End Date
May 14 2021
Last Update
February 4 2022
Active Locations (1)
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1
Hospital de Santa Bárbara Integrado
Santa Bárbara, Honduras, 22101