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NCT04771013

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

Completed Phase 2 Results posted Last updated 4 February 2022
What this trial tests

Phase 2 trial testing Thymic peptides in COVID-19 in 22 participants. Completed in 14 May 2021.

Timeline
10 February 2021
Primary endpoint
14 May 2021
14 May 2021

Quick facts

Lead sponsorUniversidad Católica de Honduras
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment22
Start date10 February 2021
Primary completion14 May 2021
Estimated completion14 May 2021
Sites1 location across Honduras

Drugs / interventions tested

Conditions studied

Sponsor

Universidad Católica de Honduras — full company profile →

Who can join

21 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Participant Recovery Primary · 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 me

GroupValue95% CI
Daily Oral Dose of Thymic Peptides63.981 – 8.019
Historic Control Group129.023 – 14.977
Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0 Primary · 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).

GroupValue95% CI
Daily Oral Dose of Thymic Peptides0
Historic Control Group5
Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects Primary · Up to 20 days

Number of participants who experience severe side effects as defined by the General Assessment of Side Effects (GASE).

GroupValue95% CI
Daily Oral Dose of Thymic Peptides0
Number of Participants That Died by Day 20 Secondary · Up to 20 days

Number of participants that died due to any reason by day 20.

GroupValue95% CI
Daily Oral Dose of Thymic Peptides0
Historic Control Group5

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Daily Oral Dose of Thymic Peptides
Serious: 0/22 (0%)
Deaths: 0/22
Historic Control Group
Serious: 5/22 (23%)
Deaths: 5/22

Serious adverse events (1 terms)

ReactionSystemDaily Oral Dose of Thymic …Historic Control Group
Death due to respiratory failureRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Death due to respiratory failure.

Data from ClinicalTrials.gov NCT04771013 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Next-generation antiviral peptides: AI-driven design, translational delivery platforms, and future therapeutic directions.
    Mashhadi Abolghasem Shirazi M, Haghighat S, Nikbakht Z, Salimkia E, et al · · 2025 · PMID 41106780 · DOI 10.1016/j.virusres.2025.199642
  2. A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19
    Ramos-Zaldívar HM, Reyes-Perdomo KG, Espinoza-Moreno NA, Dox-Cruz ET, et al · · 2021 · DOI 10.1101/2021.12.05.21267318

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Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04771013.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing