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 : Completed
First Posted : February 25, 2021
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: Thymic peptides||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||22 participants|
|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)|
|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|
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
- 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).
- 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.
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
|Hospital de Santa Bárbara Integrado|
|Santa Bárbara, Honduras, 22101|
|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|