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
|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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 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 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Héctor M Ramos, MDfirstname.lastname@example.org|
|Hospital de Santa Bárbara Integrado||Recruiting|
|Santa Bárbara, Honduras, 22101|
|Contact: Héctor M Ramos, MD +56934988958 email@example.com|
|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|