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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Pontificia Universidad Catolica de Chile | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily oral dose of thymic peptides | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymic peptides | Biological | 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Participant Recovery | 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. | During hospitalization for up to 20 days. |
| Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0 | 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). | Up to 20 days |
| Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects | Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE). | Up to 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Died by Day 20 | Number of participants that died due to any reason by day 20. | Up to 20 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Héctor M Ramos, MD | Universidad Católica de Honduras; Pontificia Universidad Católica de Chile | Study Director |
| Karla G Reyes, MD | Universidad Católica de Honduras; Universidad Mayor | Principal Investigator |
| Nelson A Espinoza, MD | Universidad Católica de Honduras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Santa Bárbara Integrado | Santa Bárbara | 22101 | Honduras |
All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
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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22 participants were enrolled in the intervention group.
A participant-level comparison based on a control group by propensity score matching from registry data was performed. This accounts for the 22 patients in the arm of the historic control group.
ClinicalTrials.gov Identifier: NCT04771013
MedRxiv: A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19. doi: https://doi.org/10.1101/2021.12.05.21267318
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Historic Control Group | A participant-level comparison based on a control group by propensity score matching from registry data was performed. For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020. Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Participant Recovery | 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. | Analyses were performed according to the intention-to-treat principle. | Posted | Median | 95% Confidence Interval | days | During hospitalization for up to 20 days. |
|
Patients were evaluated daily during their hospitalization, from day 1 through 20. Patients who agreed to follow-ups by phone communication were monitored for adverse events or side effects up to two weeks after discharge.
Adverse events ≥ Grade 3, as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), were analyzed.
Only Treatment Related Adverse Event data related to mortality was collected from the Historic Control population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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Limitations of this study include its small sample size and the lack of a prospectively randomized control group. This was a single-center study that included only mestizo population, which might have impacted its universal validity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Héctor M. Ramos-Zaldívar | GIMUNICAH | +56934988958 | hramos@unicah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2021 | Jan 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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A participant-level comparison based on registry data from the Hospital de Santa Bárbara Integrado will be performed after propensity score matching.
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|
| Referred to another hospital before day 20 |
|
| BG001 | Historic Control Group | A participant-level comparison based on a control group by propensity score matching from registry data was performed. For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020. Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Median no. of days since symptom onset | Median | Inter-Quartile Range | days |
|
| Comorbidities | Mean | Standard Deviation | Comorbidities |
|
| Coexisting conditions-Diabetes | Count of Participants | Participants |
|
| Coexisting conditions-Hypertension | Count of Participants | Participants |
|
| Coexisting conditions-Obesity | Count of Participants | Participants |
|
| Coexisting conditions-Chronic obstructive pulmonary disease | Count of Participants | Participants |
|
| Coexisting conditions-Heart Failure | Count of Participants | Participants |
|
| Coexisting conditions-Organ damage (other than lung) | Count of Participants | Participants |
|
| WHO Clinical Progression Score of 5 at hospitalization | WHO Clinical Progression Scale: 0, uninfected; 1, asymptomatic, viral RNA detected; 2, symptomatic and independent; 3, symptomatic and assistance needed; 4, hospitalised, no oxygen therapy; 5, hospitalised, oxygen by mask or nasal prongs; 6, hospitalised, oxygen by non-invasive ventilation or high flow; 7, intubation and mechanical ventilation pO2/FiO2 ≥150 or SpO2/FiO2 ≥200; 8, mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; 9, mechanical ventilation, pO2/FiO2 <150 and vasopressors, dialysis, or ECMO (extracorporeal membrane oxygenation); 10, dead. | Count of Participants | Participants |
|
| Heart rate distribution | Count of Participants | Participants |
|
| Systolic blood pressure distribution 90-219 mmHg | Count of Participants | Participants |
|
| Respiratory rate distribution | Count of Participants | Participants |
|
| Oxygen saturation distribution | Count of Participants | Participants |
|
| Temperature distribution | Count of Participants | Participants |
|
| SARS-CoV-2 positive test result | Count of Participants | Participants |
|
| OG000 |
| 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. |
| OG001 | Historic Control Group | A participant-level comparison based on a control group by propensity score matching from registry data was performed. For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020. Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin). |
|
|
| Primary | Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0 | 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). | Only Treatment Related Adverse Event data related to mortality was collected from the Historic Control population. | Posted | Count of Participants | Participants | Up to 20 days |
|
|
|
| Primary | Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects | Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE). | Treatment Related Side Effects data not collected from the Historic Control population. | Posted | Count of Participants | Participants | Up to 20 days |
|
|
|
| Secondary | Number of Participants That Died by Day 20 | Number of participants that died due to any reason by day 20. | The analysis assessed the number of patients that died in each arm by day 20. | Posted | Count of Participants | Participants | Up to 20 days |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Historic Control Group | A participant-level comparison based on a control group by propensity score matching from registry data was performed. For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020. Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin). | 5 | 22 | 5 | 22 | 0 | 22 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |