A Trial of NT-I7 in COVID-19 (SPESELPIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04501796|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19):
- Safety of a single dose of NT-I7
- The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Double-Blind NT-I7 Drug: Double-Blind Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||December 2021|
NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.
Drug: Double-Blind NT-I7
Administered by intramuscular (IM) injection
Placebo Comparator: Placebo
Placebo will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.
Drug: Double-Blind Placebo
- Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion [ Time Frame: Up to approximately 30 days ]Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.
- Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients. [ Time Frame: Up to approximately 30 days ]Assessment of the trajectory of ALC, CD4, CD8, NK, B, and MAIT cells measured at days 7, 14 and 30 after administration of NT-I7 or placebo compared to baseline values.
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): NCT04501796
|Contact: Anela Kelloggfirstname.lastname@example.org|
|Contact: Megan Andersonemail@example.com|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Contact: Anela Kellogg 240-669-2877 firstname.lastname@example.org|
|United States, Nebraska|
|University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Amy Haberman 402-559-5955|