Official Study Title: 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 (SPESELPIS)
This research study is about an experimental drug for COVID-19, called NT-I7. We are seeking individuals with mild COVID-19, an illness caused by a new coronavirus, SARS-CoV-2.
We are also studying whether the experimental drug is safe for people with COVID-19. We also want to see if it might help treat COVID-19 by supporting the immune system, which is the part of the body that helps fight infections. The drug is experimental, so it has not been proven to be safe or to work in people with COVID-19.
What does the study involve?
Eligible subjects will get 1 injection in the arm or buttock with either NT-I7 or a placebo. The placebo looks exactly like NT-I7 but does not have any drug in it. You will be assigned to get NT-I7 or the placebo by random chance, like by flipping a coin. The chances of you getting NT-I7 are the same as the chances of you getting placebo. You will not know which you get, and neither will the study team. All subjects will get standard supportive care to treat any health problems that you may have, whether related to COVID-19 or not.
This study will test different doses of NT-I7 to see whether they are safe. This is called "dose-escalation." The first group of participants will get a small amount of NT-I7 or placebo. If the first group seems safe, the second group will get a higher amount of NT-I7 or placebo. If the second group seems safe, the third group will get the highest amount, which is the amount we think is needed to help the immune system fight COVID-19. We will follow your health for 3 months after the study injection.
We will collect blood before and 6 or 7 times after the study injection, depending on how long you stay in the NIH Clinical Center. Also, we will swab inside your nose, swab the back of your throat, and collect stool before and 1 or 2 times after the study injection. During the study, you will stay as an inpatient in the NIH Clinical Center for 1 week after the study injection or longer if it is clinically indicated based on the course of your COVID-19 disease. We expect that you will be finished with the study after 3 months.
Who can participate?
- You are between 19 and 75 years old
- You have been diagnosed with mild COVID-19
- You agree to receive either the experimental study drug or placebo, to be determined at random
- You agree to stay as an inpatient in the NIH Clinical Center for 1 week after the study injection, or longer if it is clinically indicated
- You allow the NIH to store blood and tissue samples for future research
- If female, you are not pregnant or breastfeeding
- All participants must use effective birth control while on study
- You live in the DC metro area, and are able to travel to the NIH in Bethesda, Maryland
Where is it taking place?
The NIH in Bethesda, Maryland
Visit ClinicalTrials.gov for details.
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