This study is NOT currently recruiting participants.
Number
20-I-0140
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
No
Population Exclusion(s)
Pregnant Women;Children
Keywords
Lymphopenia; SARS-CoV-2; Coagulapathy; Antibodies; Cytokines
Recruitment Keyword(s)
None
Condition(s)
SARS-CoV-2
Investigational Drug(s)
Recombinant human interleukin (IL) 7-hyFc (NT-I7)
Investigational Device(s)
Intervention(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.
Objective:
To see if the drug NT-I7 is safe and effective for treating mild COVID-19.
Eligibility:
People between 18-75 years of age with mild COVID-19.
Design:
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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INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
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.
EXCLUSION CRITERIA:
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.
Principal Investigator
Referral Contact
For more information: