A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.
Overview
- Phase
- Phase 2
- Intervention
- Autophagy inhibitor (GNS651)
- Conditions
- SARS-CoV-2 (COVID-19) Infection
- Sponsor
- Centre Leon Berard
- Enrollment
- 19
- Locations
- 12
- Primary Endpoint
- 28-day survival rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit.
According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts:
- COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1).
- COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Autophagy inhibitor (GNS651)
Intervention: Autophagy inhibitor (GNS651)
Autophagy inhibitor (GNS651)
Intervention: Standard of care
Standard of care
Intervention: Standard of care
anti-NKG2A (Monalizumab)
Intervention: Standard of care
anti-NKG2A (Monalizumab)
Intervention: Monalizumab
anti-C5aR (Avdoralimab)
Intervention: Standard of care
anti-C5aR (Avdoralimab)
Intervention: Avdoralimab
Outcomes
Primary Outcomes
28-day survival rate
Time Frame: 28 days from randomization
28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. If vital status at 28 days post randomisation is not available due to early transfer in an external resuscitation unit, patients will be considered as failure at the date of the transfer. Comparison of each experimental arm (GNS561 then monalizumab for cohort1 and avdoralimab for cohort2) to control arm will be performed using a Fisher exact test.
Secondary Outcomes
- Clinical status(Day 7, Day 14, Day 28)
- Length of stay in Intensive Care Unit(3 months (i.e. at the time of last patient last visit))
- Overall survival(3 months (i.e. at the time of last patient last visit))
- Rate of throat swab negativation(Day 7, Day 14, Day 28)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(3 months (i.e. at the time of last patient last visit))
- The rate of patients with SARS-CoV-2 IgG antibodies at D7, D14 and D28(Day 7, Day 14, Day 28)
- Mean change in the ranking of the NEWS2 score from baseline to D7, D14 and D28(Day 7, Day 14, Day 28)
- Biological parameters(3 months (i.e. at the the time of last patient last visit))
- Time to clinical improvement(28 days from randomization)
- Mean change in the ranking on the ordinal scale from baseline to D7, D14 and D28(Day 7, Day 14, Day 28)
- Duration of mechanical ventilation or high flow oxygen devices(3 months (i.e. at the time of last patient last visit))
- Quantitative SARS-CoV-2 virus in throat swab and blood samples(Day 7, Day 14, Day 28)
- The rate of secondary infection by other documented pathogens (bacteria, fungi)(Day 7, Day 14, Day 28 (if available))
- Duration of hospitalization(3 months (i.e. at the time of last patient last visit))
- Cost-Effectiveness Analyses (CEA)(3 months (i.e. at the time of last patient last visit))