Moderate COVID-19 MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: XAV-19
Product Code: XAV-19
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-viral immunoglobulins
Current Sponsor code: XAV-19
Concentration unit: mg/ml milligram
Sponsors
XENOTHERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1) Male or female patient aged 18 years or over, weighing >50 Kg and 90% (at ambient air) I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening I6) Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and use a highly effective1 birth control until 90 days after the administration of study drug I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug, I8) Patient capable of giving signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 288 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 434
Exclusion criteria
Exclusion criteria: E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit E2) Patient with multiorgan failure E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization E4) Patient participating in another clinical trial with an investigative agent E5) Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the clinical efficacy of XAV-19 to that of placebo in patients with COVID-19.;Secondary Objective: The secondary objectives are: - to compare the change in clinical parameters (fever, respiratory rate, shortness of breath, thoracic pain, SpO2, supplemental O2) in patients treated with XAV-19 to that in patients treated with Placebo, - to compare the length of hospital stay of patients treated with XAV-19 to that of patients treated with Placebo, - to compare the viral status of patients treated with XAV-19 to that of patients treated with Placebo, - to compare the safety profile in patients with COVID-19 treated with XAV-19 to that in patients treated with Placebo ;Primary end point(s): The primary endpoint is the proportion of patients with an aggravation of COVID-19 within 8 days after treatment. The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO-7 ordinal scale at randomization.;Timepoint(s) of evaluation of this end point: Within 8 days after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Proportion of patients with an aggravation of COVID-19 within 15 days after treatment, • Proportion of patients with an improvement, no change, or an aggravation on the WHO-7 ordinal scale at Day 15 compared to the score at Day 8 • Change in clinical parameters between randomization and Day 3, 5, 8 and 15: fever (>38°C), respiratory rate, SpO2, supplemental O2, • Change in severity, on Common Terminology Criteria of Adverse Events (CTCAE) scale, between randomization and Day 3, 5, 8 and 15: shortness of breath and thoracic pain (See Appendix 12.2), • Duration of patient’s requirement in supplemental O2, • Duration of aggravation • Length of hospital stay, • Clinical status at Day 3 and Day 15 using the WHO 7-point ordinal scale for COVID-19, • Viral status: RT-PCR for SARS-CoV-2 (positive/negative) at randomization and on Day 8 or at the end of follow-up, whichever comes first • Viral load (if local practice enables it): RT-qPCR for SARS-CoV-2 at randomization and on Day 8 or at the end of follow-up, whichever comes first • Proportion of patients referred to ICU between randomization and Day 3, 5, 8 and 15, • Proportion of patients with need for mechanical ventilation at randomization and at Day 3, 5, 8 and 15, • Eight- and 15-day survival rates, defined by the crude proportion of patients still alive 8 or 15 days after randomization • Safety parameters (i.e. adverse events, hypersensitivity or allergy, white and red blood cells, liver enzymes, creatinine);Timepoint(s) of evaluation of this end point: Between randomization and Day 3, 5, 8 and 15. | — |
Countries
Bulgaria, Greece, Romania, Spain, Turkey
Contacts
Public ContactChief Operating Officer
XENOTHERA
Outcome results
None listed