Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3. Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients. A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans. The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.
Description: The primary endpoint is measurement of the antibody titer XAV-19 in all treated patients and in all patients in the placebo group at Day 8
Measure: Phase 2a: XAV-19 antibody titers Time: Day 8Description: Adverse events of XAV-19 between the two groups of treated patients and vs. placebo over 29 days
Measure: Phase 2a: Adverse events of XAV-19 Time: Day 29Description: Efficacy is defined by the proportion of patients who die or develop respiratory failure in the two groups of treatment between baseline and Day 15. Patient with respiratory failure will be patient requiring noninvasive ventilation, high-flow oxygen devices or invasive mechanical ventilation (corresponding to 8-point ordinal scale ≥ 6).
Measure: Phase 2b: Time to weaning of supplemental oxygen. Time: Day 15Description: XAV-19 Antibody titer over the time
Measure: Phase 2a: Pharmacokinetic analysis Time: Day 1 (pre-dose, post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day 15, and Day 29Description: The antibody titer of XAV-19 measurements in Group 1 treated patients and Group 2 treated patients
Measure: Phase 2a: Antibody titer between the two groups Time: day 15Description: Duration of supplemental oxygen
Measure: Phase 2a: Supplemental oxygen Time: Day 1 to Day 29Description: Transfer to intensive care unit with need for invasive mechanical ventilation or high flow oxygen
Measure: Phase 2a: Evaluation of Transfer to intensive care Time: Day 1 to Day 29Description: Normalization of fever ≥ 24 hours: clinical assessment every day from Day 1 to Day 14. Evaluation to be performed between 8 and 12 am, Day X evaluation will consider the higher value during Day X-1
Measure: Phase 2a: Normalization of Fever Time: Day 1 to Day 29Description: Biomarkers : CRP, Ferritin
Measure: Phase 2a: Biomarkers Time: Day 1 to Day 29Description: Evaluation of Hospital length of stay
Measure: Phase 2a: Hospital length of stay Time: Day 1 to Day 29Description: a) Proportion of patients who die, develop respiratory failure (requiring noninvasive ventilation, high-flow oxygen devices or invasive mechanical ventilation) between baseline and Day 8, then between baseline and D29
Measure: Phase 2b: Efficacy of XAV-19 Time: Day 8 and Day 29Description: b) National Early Warning Score (NEWS) at Day 15 and difference in NEWS between baseline and D8 / D15 / D29
Measure: Phase 2b: National Early Warning Score (NEWS) Time: Day 8, Day 15 and Day 29Description: c) Clinical status using the 8-point ordinal scale assessed and difference between baseline and D3, D5, D8, D15, and D29
Measure: Phase 2b: clinical status Time: Day 3, Day 5, Day 8, Day15, and Day 29Description: d) Time to improvement of one category from admission using the 8-point ordinal scale. This scale is rated 0 to 8 with score 0 being the better score (no clinical impact) and 8 being the worst score (death)
Measure: Phase 2b: Time to improvement Time: 29 DaysDescription: e) Time to first fever normalization (criteria for normalization: temperature < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal or tympanic)
Measure: Phase 2b: fever normalization Time: 29 DaysDescription: f) Duration of oxygen therapy
Measure: Phase 2b: Oxygen therapy Time: 29 DaysDescription: g) Comparison of oxygen requirement between the two groups
Measure: Phase 2b: oxygen requirement Time: 29 DaysDescription: h) Time to weaning in supplemental oxygen and proportion without O2 requirement at Day 8, D15 and Day 29, according to baseline (D1) oxygen requirement (≤ 4 L/min or 4 L/min)
Measure: Phase 2b: Time to weaning Time: Day8, Day 15 and Day 29Description: i) Incidence and duration of non-invasive ventilation or high flow oxygen devices, of invasive mechanical ventilation during the study
Measure: Phase 2b: Ventilation Time: 29 DaysDescription: j) Evaluation of hospital length of stay
Measure: Phase 2b: Hospital length of stay Time: 29 DaysDescription: k) All cause mortality
Measure: Phase 2b: mortality Time: 29 DaysDescription: l) Occurrence of all suspected XAV-19 related adverse effects or Incidence of serious adverse events Proportion of participants with treatment emergent adverse events leading to study drug discontinuation Incidence of major or opportunistic bacterial or fungal infections Incidence of hypersensitivity reactions and infusion reactions White cell count, hemoglobin, platelets, creatinine, ALT, AST, on D1, D3, D5, D8, D11, D15 and D29 SARS-CoV-2 viral load over time (D1-D29), as collected by nasopharyngeal swab samples Time to RT-PCR virus negativity in nasopharyngeal swab samples
Measure: Phase 2b: safety Time: 29 DaysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports