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Protocol Details

A Double-Blind, Randomized, Placebo-Controlled, Phase 1, Single-Dose, Dose-Escalating Trial of Long-Acting Recombinant Human IL-7 (NT-I7) for COVID-19

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 19 Years
Max Age: 75 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;



Recruitment Keyword(s)




Investigational Drug(s)

Recombinant human interleukin (IL) 7-hyFc (NT-I7)

Investigational Device(s)



Biological/Vaccine: Recombinant human interleukin 7-hyFc
Other: Placebo

Supporting Site

National Institute of Allergy and Infectious Diseases


COVID-19 is a disease caused by a novel coronavirus called SARS-CoV-2. There is no vaccine to prevent SARS-CoV-2 or therapy to treat early mild COVID-19. NT-I7 is a drug that helps the body make white blood cells that fight germs like viruses. Researchers want to see if NT-I7 might help prevent some serious complications of COVID-19.


To see if the drug NT-I7 is safe and effective for treating mild COVID-19.


People between 18-75 years of age with mild COVID-19.


Participants will be screened with:

Medical and medication history

COVID-19 symptoms

Physical exam

Pregnancy test (if needed)

Blood tests

Some screening tests will be repeated during the study.

Participants will have up to 8 study visits. They will stay as an inpatient at the NIH Clinical Center for a week or longer.

Participants will get NT-I7 or placebo as an injection into the muscle of the upper arm or buttock.

Participants will have blood taken. They may give stool samples.

Participants will have throat swabs. A cotton swab will be inserted into the back of the throat.

Participants will have nasal swabs. A cotton swab will be inserted in the nostril to soak up mucus.

Participants will have an electrocardiogram to measure the heart s electrical activity. They will lie down. Sticky pads will be placed on their arms, legs, and chest.

Participants' health will be followed for 3 months to see if they have reactions or side effects to the study injection and to monitor their COVID-19

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Individuals must meet all of the following criteria to be included in the study:

- Laboratory-confirmed SARS-CoV-2 infection as determined by one of the following:

--Documented positive molecular assay or other commercial or public health assay in any specimen collected < 5 days prior to screening; or

--Documented positive molecular assay greater than or equal to 5 days prior to screening and confirmed by polymerase chain reaction (PCR) at screening.

- Illness of any duration with oxygen saturation > 93% at room air, heart rate less than or equal to 100 beats per minute at rest, and no evidence of respiratory distress with respiration rate <= 20 breaths per minute.

-Able to provide informed consent.

-Aged greater than or equal to 19 and less than or equal to 75 years.

-ALC < 2,000 lymphocytes/micro L.

-Individuals of reproductive potential must agree to avoid becoming pregnant or impregnating a partner from the time of screening through 90 days after study agent administration. These individuals must agree to abstinence or the use of 1 or 2 of the following acceptable forms of contraception: male or female condoms, diaphragms or cervical caps with a spermicide, intrauterine devices, or hormonal contraception methods.

--Females of childbearing potential must agree to use at least 2 acceptable forms of contraception. (A female is considered to be of non-childbearing potential if she meets one or more of the follow criteria: menopausal [defined as being 50 years old or more with NO menstrual periods in the past 12 months]; or has absence of a uterus, both fallopian tubes [absent/removed, not tied/cut], or both ovaries.)

--Males of reproductive potential must agree to use at least 1 acceptable form of contraception.

- Males must agree not to donate sperm within 90 days after study agent administration.

-Females must agree not to breastfeed within 90 days after study agent administration.

-Agrees to not participate in any other clinical trial for an investigational therapy through the end of the study.


Individuals meeting any of the following criteria are not eligible for enrollment in the study:

-Moderate to severe hypoxic respiratory failure requiring supplemental oxygen at rest, mechanical ventilation, ECMO, or any other noninvasive ventilation modality.

-CRP >15 mg/L or D-dimer > 0.75 micro g/mL.

-Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m^2, or requiring dialysis.

-AST/ALT > 3-times the upper limit of normal (ULN), or total bilirubin > 1.5-times ULN (except if due to Gilbert s syndrome).

-Pregnancy or breastfeeding.

-Use of systemic corticosteroids or immunomodulant within 4 weeks prior to screening.

-Receipt of an investigational agent or investigational use of a licensed agent within 16 weeks prior to screening. A participant who received a COVID-19 vaccine administered under FDA approval or EUA within this time frame may participate.

-Underlying history of known or unknown primary or acquired immunodeficiency associated with lymphopenia and/or recurrent opportunistic infections.

Exception: People with HIV infection are eligible if they are on a stable antiretroviral regimen for > 6 months with evidence of suppressed HIV viremia and CD4 counts > 300 cells/micro L, as documented in medical records.

-Any established diagnosis of autoimmune disease requiring systemic treatment EXCEPT for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy.

-Malignancy requiring chemotherapy, radiation, or immunomodulant therapy within 1 year prior to screening.

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Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. PMID: 32171076; PMCID: PMC7270627.

Grifoni A, Weiskopf D, Ramirez SI, Mateus J, Dan JM, Moderbacher CR, Rawlings SA, Sutherland A, Premkumar L, Jadi RS, Marrama D, de Silva AM, Frazier A, Carlin AF, Greenbaum JA, Peters B, Krammer F, Smith DM, Crotty S, Sette A. Targets of T Cell Responses to SARS-CoV-2 Coronavirus in Humans with COVID-19 Disease and Unexposed Individuals. Cell. 2020 Jun 25;181(7):1489-1501.e15. doi: 10.1016/j.cell.2020.05.015. Epub 2020 May 20. PMID: 32473127; PMCID: PMC7237901.

Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmel(SqrRoot)(Copyright) T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960. PMID: 29515037; PMCID: PMC5922293.

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Principal Investigator

Referral Contact

For more information:

Irini Sereti, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 496-5533

Irini Sereti, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 496-5533

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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