Phase 2
N=44
Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04771013 ↗Enrolled (actual)
44
Serious AEs
11.4%
Results posted
Feb 2022
Primary outcome: Primary: Time to Participant Recovery — 6; 12 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thymic peptides (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Universidad Católica de Honduras
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Participant Recovery |
6; 12 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 5.0 |
0; 5 | — |
| PRIMARY Number of Participants With Treatment Related Side Effects as Assessed by the General Assessment of Side Effects |
— | — |
| SECONDARY Number of Participants That Died by Day 20 |
0; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04771013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.