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Study · Randomized controlled trial · 2023

4 results

A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection.

Shehadeh F, Benitez G, Mylona EK, Tran QL, Tsikala-Vafea M, Atalla E, Kaczynski M, Mylonakis E

The Journal of infectious diseases1 Jan 2023Cited by 9 (Europe PMC)

PMID36056913 (opens in a new tab)PMCIDPMC9494344 (opens in a new tab)DOI10.1093/infdis/jiac362 (opens in a new tab)PepBankPUB-36056913
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In hospitalized adults with COVID-19, hypoxemia and lymphocytopenia on low-flow oxygen, thymalfasin gave a higher incidence of clinical recovery than standard of care, but the difference was not significant.

    In plain wordsIn hospitalized COVID-19 patients on low-flow oxygen, more thymalfasin patients recovered than with standard care, but the difference was not significant.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeClinical recovery, baseline low-flow oxygen
    Study

    n: not reported in source

    Comparator
    Standard of care
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    Dose not stated

    Measurements

    subdistribution hazard ratio
    1.48 ratio
    baseline low-flow oxygen

    Source sentences

    Summary
    Compared with control patients, the incidence of clinical recovery was higher for treated patients with either baseline low-flow oxygen (subdistribution hazard ratio, 1.48 [95% confidence interval, .68-3.25]) or baseline high-flow oxygen (1.28 [.35-4.63]), although neither difference was significant.
    2 context sentences
    Summary · context
    Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
    Summary · context
    A total of 49 patients were included in this analysis.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In hospitalized adults with COVID-19, hypoxemia and lymphocytopenia on high-flow oxygen, thymalfasin gave a higher incidence of clinical recovery than standard of care, but the difference was not significant.

    In plain wordsIn hospitalized COVID-19 patients on high-flow oxygen, more thymalfasin patients recovered than with standard care, but the difference was not significant.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeClinical recovery, baseline high-flow oxygen
    Study

    n: not reported in source

    Comparator
    Standard of care
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    Dose not stated

    Measurements

    subdistribution hazard ratio
    1.28 ratio
    baseline high-flow oxygen

    Source sentences

    Summary
    Compared with control patients, the incidence of clinical recovery was higher for treated patients with either baseline low-flow oxygen (subdistribution hazard ratio, 1.48 [95% confidence interval, .68-3.25]) or baseline high-flow oxygen (1.28 [.35-4.63]), although neither difference was significant.
    2 context sentences
    Summary · context
    Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
    Summary · context
    A total of 49 patients were included in this analysis.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In hospitalized adults with COVID-19 on low-flow oxygen, thymalfasin raised the day 5 to day 1 CD4+ T-cell ratio by 3.84 times more than standard of care.

    In plain wordsIn hospitalized COVID-19 patients on low-flow oxygen, thymalfasin increased CD4+ T cells more than standard care did.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseCD4+ T-cell count, day 5 versus day 1, baseline low-flow oxygen
    Study

    n: not reported in source

    Comparator
    Standard of care
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    CD4+ T-cell day 5 to day 1 ratio, difference
    3.84 fold
    baseline low-flow oxygen

    Source sentences

    Summary
    Among patients with baseline low-flow oxygen, treated patients, compared with control patients, had an average difference of 3.84 times more CD4+ T cells on day 5 than on day 1 (P = .01).
    2 context sentences
    Summary · context
    Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
    Summary · context
    A total of 49 patients were included in this analysis.
  4. 04HumanRandomized controlled trialSafety outcome

    In hospitalized adults with COVID-19, nine serious adverse events among thymalfasin-treated patients were judged not related to thymosin alpha‑1.

    In plain wordsIn hospitalized COVID-19 patients, nine serious adverse events in the thymalfasin group were judged not related to the treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Nine serious adverse events among treated patients were deemed not related to Tα1.
    2 context sentences
    Summary · context
    Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
    Summary · context
    A total of 49 patients were included in this analysis.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 2NCT04487444

Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection

Rhode Island Hospitaln = 5610 Sept 2020 to 3 Feb 2023

Covid19

Trial pageClinicalTrials.govUpdated 14 Feb 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    10 Oct 2026, 08:19 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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