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

NCT04487444 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: SCN-16130571-2
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

thymosin alpha 1; lymphocytopenia; thymalfasin

Outcome Measures

Primary Outcomes (1)

• Time to recovery (free of respiratory failure)

  Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air

  Day 28

Secondary Outcomes (14)

• Lymphopenia

  Day 14

• Survival

  Day 28

• Hospital length of stay

  Day 28

• Requirement for high flow oxygen supplementation

  Day 28

• Duration of high flow oxygen supplementation

  Day 28

Study Arms (2)

Ta1 treatment arm

EXPERIMENTAL

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.

Drug: Thymalfasin

Control arm

NO INTERVENTION

No treatment will be provided in addition to standard of care.

Interventions

Thymalfasin DRUG

Synthetic 28 amino acid peptide identical to naturally circulating compound

Also known as: Thymosin alpha 1, ZADAXIN (brand name), Ta1 (abbreviation)

Ta1 treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

• Liu Y, Pan Y, Hu Z, Wu M, Wang C, Feng Z, Mao C, Tan Y, Liu Y, Chen L, Li M, Wang G, Yuan Z, Diao B, Wu Y, Chen Y. Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells. Clin Infect Dis. 2020 Nov 19;71(16):2150-2157. doi: 10.1093/cid/ciaa630.

  PMID: 32442287 BACKGROUND

• Shehadeh F, Benitez G, Mylona EK, Tran QL, Tsikala-Vafea M, Atalla E, Kaczynski M, Mylonakis E. A Pilot Trial of Thymalfasin (Thymosin-alpha-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. J Infect Dis. 2023 Jan 11;227(2):226-235. doi: 10.1093/infdis/jiac362.

  PMID: 36056913 RESULT

MeSH Terms

Conditions

COVID-19; Lymphopenia

Interventions

Thymalfasin; Trace amine-associated receptor 1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Eleftherios Mylonakis, MD PhD FIDSA

  Lifespan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: September 10, 2020
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 14, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)