Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection (Ta1)
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ClinicalTrials.gov Identifier: NCT04487444 |
Recruitment Status :
Recruiting
First Posted : July 27, 2020
Last Update Posted : September 16, 2021
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It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia.
After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.
Condition or disease | Intervention/treatment | Phase |
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Covid19 | Drug: Thymalfasin | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia |
Actual Study Start Date : | September 10, 2020 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
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Experimental: Ta1 treatment arm
Ta1 at a dose of 1.6 mg will be administered SC in 1 mL of diluent daily for a total of 1 week, in addition to standard of care.
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Drug: Thymalfasin
Synthetic 28 amino acid peptide identical to naturally circulating compound
Other Names:
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No Intervention: Control arm
No treatment will be provided in addition to standard of care.
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- Time to recovery (free of respiratory failure) [ Time Frame: Day 28 ]Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air
- Lymphopenia [ Time Frame: Day 14 ]Evaluation of CD4 and CD8 levels
- Survival [ Time Frame: Day 28 ]Percentage of subjects still alive
- Hospital length of stay [ Time Frame: Day 28 ]Length of time before hospital discharge
- Requirement for high flow oxygen supplementation [ Time Frame: Day 28 ]Number of subjects that require high flow oxygen
- Duration of high flow oxygen supplementation [ Time Frame: Day 28 ]Number of days that each subject requires high flow oxygen
- ICU admission [ Time Frame: Day 28 ]Number of subjects that are admitted to the ICU
- ICU length of stay [ Time Frame: Day 28 ]Number of days that each subject remains in the ICU
- Mechanical ventilation [ Time Frame: Day 28 ]Number of subjects that require mechanical ventilation
- Duration of mechanical ventilation [ Time Frame: Day 28 ]Number of days that each subject requires the mechanical ventilation
- Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease [ Time Frame: Day 28 ]Number of subjects that have decreases or increases in comorbidities existing at time of enrollment
- Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.) [ Time Frame: Day 28 ]Number of subjects who get infections other than COVID-19
- AEs/SAEs [ Time Frame: Day 60 ]Adverse events and serious adverse events experienced by the subjects
- Changes to vital signs [ Time Frame: Day 28 ]Mild, moderate, or severe changes to vital signs (heart rate, blood pressure, temperature, number of respirations per minute) based on perceived clinical significance of the change
- Changes in laboratory parameters [ Time Frame: Day 28 ]Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent
- PCR positive for COVID-19 within the last 4 days
- Hospitalized
- SpO2 ≤ 93% on room air or requiring supplemental oxygen at screening (i.e. patients with severe disease)
- Lymphopenia (total lymphocyte count < 1.5 × 109/L)
Exclusion Criteria:
- Patients on mechanical ventilation
- Patients who are pregnant or breastfeeding
- Patients with multi-organ failure
- Patients with advanced malignancy receiving cytotoxic chemotherapy
- Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant
- Patients on any other immunomodulatory therapy
- Patients receiving Plaquenil
- Patients who have participated in an investigational drug or device trial in previous 30 days
- Patients with a history of allergy or intolerance to Ta1
- Any other medical or psychiatric condition that, in the opinion of the Investigator, would compromise patient safety or interfere with the objectives of the protocol or completion of the protocol treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487444
Contact: Eleftherios Mylonakis, MD PhD FIDSA | 401-444-7856 | emylonakis@lifespan.org | |
Contact: Fadi Shehadeh | 401-444-4969 | fadi_shehadeh@brown.edu |
United States, Rhode Island | |
The Miriam Hospital | Recruiting |
Providence, Rhode Island, United States, 02906 |
Principal Investigator: | Eleftherios Mylonakis, MD PhD FIDSA | Lifespan |
Responsible Party: | Rhode Island Hospital |
ClinicalTrials.gov Identifier: | NCT04487444 |
Other Study ID Numbers: |
SCN-16130571-2 |
First Posted: | July 27, 2020 Key Record Dates |
Last Update Posted: | September 16, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
thymosin alpha 1 lymphocytopenia thymalfasin |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Thymalfasin Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |