Trial Outcomes & Findings for Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras (NCT NCT04771013)
NCT ID: NCT04771013
Last Updated: 2022-02-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
During hospitalization for up to 20 days.
Results posted on
2022-02-04
Participant Flow
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
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
0
|
5
|
|
Overall Study
Referred to another hospital before day 20
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras
Baseline characteristics by cohort
| Measure |
Daily Oral Dose of Thymic Peptides
n=22 Participants
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.
|
Historic Control Group
n=22 Participants
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).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 16 • n=5 Participants
|
57 years
STANDARD_DEVIATION 17 • n=7 Participants
|
54 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Age, Customized
≤60 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Customized
61-64 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Honduras
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Median no. of days since symptom onset
|
11.5 days
n=5 Participants
|
10 days
n=7 Participants
|
10.5 days
n=5 Participants
|
|
Comorbidities
|
2 Comorbidities
STANDARD_DEVIATION 1 • n=5 Participants
|
2 Comorbidities
STANDARD_DEVIATION 2 • n=7 Participants
|
2 Comorbidities
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Coexisting conditions-Diabetes
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Coexisting conditions-Hypertension
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Coexisting conditions-Obesity
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Coexisting conditions-Chronic obstructive pulmonary disease
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Coexisting conditions-Heart Failure
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Coexisting conditions-Organ damage (other than lung)
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
WHO Clinical Progression Score of 5 at hospitalization
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Heart rate distribution
51-90 beats/min
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Heart rate distribution
91-110 beats/min
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Heart rate distribution
111-130 beats/min
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Systolic blood pressure distribution 90-219 mmHg
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Respiratory rate distribution
21-24 breaths/min
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Respiratory rate distribution
≥ 25 breaths/min
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Oxygen saturation distribution
92-93%
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Oxygen saturation distribution
≤91%
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Temperature distribution
35.6-37.9 °C
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Temperature distribution
38-39 °C
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Temperature distribution
≥39.1 °C
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
SARS-CoV-2 positive test result
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During hospitalization for up to 20 days.Population: Analyses were performed according to the intention-to-treat principle.
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.
Outcome measures
| Measure |
Daily Oral Dose of Thymic Peptides
n=22 Participants
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.
|
Historic Control Group
n=22 Participants
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).
|
|---|---|---|
|
Time to Participant Recovery
|
6 days
Interval 3.981 to 8.019
|
12 days
Interval 9.023 to 14.977
|
PRIMARY outcome
Timeframe: Up to 20 daysPopulation: Only Treatment Related Adverse Event data related to mortality was collected from the Historic Control population.
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).
Outcome measures
| Measure |
Daily Oral Dose of Thymic Peptides
n=22 Participants
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.
|
Historic Control Group
n=22 Participants
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).
|
|---|---|---|
|
Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 20 daysPopulation: Treatment Related Side Effects data not collected from the Historic Control population.
Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE).
Outcome measures
| Measure |
Daily Oral Dose of Thymic Peptides
n=22 Participants
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.
|
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).
|
|---|---|---|
|
Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 20 daysPopulation: The analysis assessed the number of patients that died in each arm by day 20.
Number of participants that died due to any reason by day 20.
Outcome measures
| Measure |
Daily Oral Dose of Thymic Peptides
n=22 Participants
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.
|
Historic Control Group
n=22 Participants
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).
|
|---|---|---|
|
Number of Participants That Died by Day 20
|
0 Participants
|
5 Participants
|
Adverse Events
Daily Oral Dose of Thymic Peptides
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historic Control Group
Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Daily Oral Dose of Thymic Peptides
n=22 participants at risk
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.
|
Historic Control Group
n=22 participants at risk
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).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death due to respiratory failure
|
0.00%
0/22 • 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.
|
22.7%
5/22 • Number of events 5 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place