Intravenously administered interleukin-7 to reverse lymphopenia in patients with septic shock: a double-blind, randomized, placebo-controlled trial
- halted early
- Study halted early because of fever and respiratory distress after intravenous CYT107
Authors' conclusion
Intravenous CYT107 reversed sepsis-induced lymphopenia. However, compared to intramuscular CYT107 administration, it was associated with transient respiratory distress without long-term sequelae.
Study context
- Population
- Patients with septic shock and sepsis-induced lymphopenia, eight French and two US sitesplanned 40
- Participants
- 21 patients
- Comparison
- Intravenous CYT107 vs placebo
- CYT107n = 15
- Placebon = 6reference
Methodological detailsprospective, double-blinded, placebo-controlled, 3:1 randomisation, multicentre
- Prospective
- Double-blinded
- Placebo-controlled
- 3:1 randomisation
- Multicentre
Primary result
As reported in the abstract
Absolute lymphocyte counts
- Two-threefold increase in absolute lymphocyte counts (incl. CD4+ and CD8+ T cells) with CYT107 vs placebo, maintained throughout follow-up, reversing severe lymphopenia
- all p < 0.05
Further findings
Organ support free days (OSFD)
- Lymphocyte increase associated with increase in OSFD
CYT107 blood concentration
- ≈100-fold higher with intravenous vs intramuscular CYT107
Safety
- Fever and respiratory distress ≈5-8 h after drug administration — CYT107
- 3 events
- Fever and respiratory distress ≈5-8 h after drug administration: 3 of 15; led to early halt of the study
Cytokine storm and anti-CYT107 antibodies
- No cytokine storm and no anti-CYT107 antibody formation observed
Original publication
Intravenously administered interleukin-7 to reverse lymphopenia in patients with septic shock: a double-blind, randomized, placebo-controlled trial. Ann Intensive Care. Published 12 March 2023. doi:10.
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