A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19
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Abstract
Background
Coronavirus disease 2019 (Covid-19) active cases continue to demand the development of safe and effective treatments. This is the first clinical trial to evaluate the safety and efficacy of oral thymic peptides.
Methods
We conducted a nonrandomized phase 2 trial with a historic control group to evaluate the safety and efficacy of a daily 250-mg oral dose of thymic peptides in the treatment of hospitalized Covid-19 patients. Comparison based on standard care from registry data was performed after propensity score matching. The primary outcomes were survival, time to recovery and the number of participants with treatment-related adverse events or side effects by day 20.
Results
A total of 44 patients were analyzed in this study, 22 in the thymic peptides group and 22 in the standard care group. There were no deaths in the intervention group, compared to 24% mortality in standard care by day 20 (log-rank P=0.02). The Kaplan-Meier analysis showed a significantly shorter time to recovery by day 20 in the thymic peptides group as compared with standard care (median, 6 days vs. 12 days; hazard ratio for recovery, 2.75 [95% confidence interval, 1.34 to 5.62]; log-rank P=0.002). No side effects or adverse events were reported.
Conclusion
In patients hospitalized with Covid-19, the use of thymic peptides reported no side effects, adverse events, or deaths by day 20. When compared with registry data, a significantly shorter time to recovery and mortality reduction was measured. The Catholic University of Honduras Medical Research Group (GIMUNICAH) is working on a more extensive phase 3 trial.
Trial registration
ClinicalTrials.gov NCT04771013 . February 25, 2021.
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SciScore for 10.1101/2021.12.05.21267318: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: 2.5 Ethics approval: Written informed consent prior to inclusion in the study was obtained from all participants or a legal representative if they were unable to provide it. Sex as a biological variable 24 Pregnant and breast-feeding women, as well as organ transplant recipients, were not eligible. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Hospitalized patients who were 21 years of age or older (with no upper age limit) with confirmed Covid-19 by detection of viral nucleic acid (RNA), viral antigen, or antibodies to the virus were eligible for enrollment. viral nucleic acid (RNA), viral antigen,suggested: NoneSciScore for 10.1101/2021.12.05.21267318: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: 2.5 Ethics approval: Written informed consent prior to inclusion in the study was obtained from all participants or a legal representative if they were unable to provide it. Sex as a biological variable 24 Pregnant and breast-feeding women, as well as organ transplant recipients, were not eligible. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Hospitalized patients who were 21 years of age or older (with no upper age limit) with confirmed Covid-19 by detection of viral nucleic acid (RNA), viral antigen, or antibodies to the virus were eligible for enrollment. viral nucleic acid (RNA), viral antigen,suggested: NoneSoftware and Algorithms Sentences Resources 2.4 Statistics: For the comparison group, propensity score matching using IBM SPSS ver.25 (IBM Co., Armonk, NY, USA) was performed based on registry data from HSBI. SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:29 Limitations of our study include its small sample size and the lack of a prospectively randomized control group. However, valuable information was acquired through PSM of registry data that accounts for standard care results in a group of patients globally similar in baseline characteristics of possible severity confounders. Also, poor socioeconomic conditions could have influenced the low remote cellphone follow-up response rate after discharge (55%) by lack of patient access to internet or a service plan. A phase 3 trial by the GIMUNICAH group is underway to address the need for confirmatory analyses in a larger population. This was a single-center study that included only mestizo population, which might have impacted its universal validity. Nonetheless, given the underrepresentation of this population in Covid-19 clinical trials, data obtention is highly relevant. 30 In conclusion, given that a dysregulated immune/inflammatory response promotes tissue damage in later phases of COVID-19,8 the use of thymic peptides should be further examined and considered to improve immunomodulation and clinical outcomes in the complex management of the disease. The daily oral dose of 250 mg of thymic peptides proved to be safe in a hospitalized Covid-19 group of patients in Honduras, reporting no deaths by day 20. When compared with registry data after PSM, shorter times to oxygen therapy withdrawal, recovery, and length of stay, as well as reduction in mortality were identified. Trial...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04771013 Completed Safety and Efficacy of Thymic Peptides in the Treatment of H… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- No funding statement was detected.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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