COVID-19Phase 2NCT04771013

Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras

A Phase 2 study testing Thymic peptides in people with COVID-19, run by Universidad Católica de Honduras at 1 site in Honduras.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: COVID-19
What is being tested?: Thymic peptides
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteHonduras
Study dates: 10 Feb 2021to 14 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Honduras1 site

Hospital de Santa Bárbara Integrado
Santa Bárbara, 22101

Other trials in Honduras

About this study

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

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.

Read the 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 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.

Conditions: COVID-19
Being tested: Thymic peptides
Keywords: SARS-CoV-2 Infection, COVID-19 Pandemic, 2019 Novel Coronavirus Disease, Thymic peptides, Thymus gland, Peptides, Honduras, Coronavirus Disease 2019, Coronavirus Disease-19, COVID-19 Virus Infection, 2019-nCoV Disease, 2019-nCoV Infection
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thymic peptidesBiological
Also called Unicahsina
250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.

Study groups in NCT04771013
Study group	Role	What they receive
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. Receives: Biological: Thymic peptides

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: Up to 20 days

Secondary outcomes (1)

Number of Participants That Died by Day 20
Number of participants that died due to any reason by day 20.
Measured: Up to 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202114 May 2021

First posted25 Feb 2021
Study start10 Feb 2021
Primary completion14 May 2021
Study completion14 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04771013
Sponsor's protocol ID: AEC-01-2021
Other IDs: COM-2020-01, AEC-01-2021
Status last verified: Feb 2022
First submitted: 24 Feb 2021
Last updated: 4 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04771013
Acronym / sponsor ID: AEC-01-2021
Conditions: COVID-19
Keywords: SARS-CoV-2 Infection, COVID-19 Pandemic, 2019 Novel Coronavirus Disease, Thymic peptides, Thymus gland, Peptides, Honduras, Coronavirus Disease 2019
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Universidad Católica de HondurasUniversity, hospital or other
Collaborators: Pontificia Universidad Catolica de Chile
Study start: 10 Feb 2021 (actual)
Primary completion: 14 May 2021 (actual)
Study completion: 14 May 2021 (actual)
First posted: 25 Feb 2021 (actual)
Results: Posted 4 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A participant-level comparison based on registry data from the Hospital de Santa Bárbara Integrado will be performed after propensity score matching.

Arm	Type	Receives
Daily oral dose of thymic peptides	Experimental	Biological: Thymic peptidesPatients 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thymic peptidesAlso: Unicahsina250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.	Biological	Daily oral dose of thymic peptides

Primary outcome

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).

1 secondary outcome

Number of Participants That Died by Day 20
Time frame: Up to 20 days

Results and safety

Results posted to the registry on 4 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daily Oral Dose of Thymic Peptides	22	20
Historic Control Group	22	16

Primary outcome: Time to Participant Recovery

Time frame: During hospitalization for up to 20 days.. Median (95% Confidence Interval). Unit: days

Measure	Daily Oral Dose of Thymic Peptides n = 22	Historic Control Group n = 22
Value	6 (3.981 to 8.019)	12 (9.023 to 14.977)

Population analysed: Analyses were performed according to the intention-to-treat principle.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Daily Oral Dose of Thymic Peptides n = 22	Historic Control Group n = 22
Value	0	5

Population analysed: Only Treatment Related Adverse Event data related to mortality was collected from the Historic Control population.

Primary outcome: Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects

Time frame: Up to 20 days. Count of participants. Unit: Participants

Measure	Daily Oral Dose of Thymic Peptides n = 22
Value	0

Population analysed: Treatment Related Side Effects data not collected from the Historic Control population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daily Oral Dose of Thymic Peptides	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Historic Control Group	5 of 22 (22.7%)	0 of 22 (0%)	5 of 22

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Héctor M Ramos, MD study director

Universidad Católica de Honduras; Pontificia Universidad Católica de Chile

Karla G Reyes, MD principal investigator

Universidad Católica de Honduras; Universidad Mayor

Nelson A Espinoza, MD principal investigator

Universidad Católica de Honduras

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thymic peptides in people with COVID-19, run by Universidad Católica de Honduras at 1 site in Honduras.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Participant Recovery (time frame: During hospitalization for up to 20 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04771013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.