InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I ) : A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort
Approximately forty-eight (48) participants will be randomized 1:1 to receive(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)Intramuscular (IM) placebo (normal saline) at the same frequency. The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.This cohort excludes oncology patients on treatment.
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 08. Apr. Zur Gesamtaufnahme - year:2022 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: June 22, 2020, Last downloaded: ClinicalTrials.gov processed this data on April 18, 2022, Last updated: April 20, 2022 |
|---|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG003433145 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG003433145 | ||
| 003 | DE-627 | ||
| 005 | 20230425205056.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210408s2022 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG003433145 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT04442178 | ||
| 035 | |a (UBBS_Klinische_Studien)ILIAD-7 COVID US INFECTIOUS | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I ) |b A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: June 22, 2020, Last downloaded: ClinicalTrials.gov processed this data on April 18, 2022, Last updated: April 20, 2022 | ||
| 520 | |a Approximately forty-eight (48) participants will be randomized 1:1 to receive(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)Intramuscular (IM) placebo (normal saline) at the same frequency. The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.This cohort excludes oncology patients on treatment | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Lymphopenia | |
| 650 | 4 | |a Medical Condition: COVID-19, Lymphocytopenia | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2022) vom: 08. Apr. |
| 773 | 1 | 8 | |g year:2022 |g day:08 |g month:04 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04442178 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 912 | |a SSG-OLC-PHA | ||
| 951 | |a AR | ||
| 952 | |j 2022 |b 08 |c 04 | ||