COVID-19
Conditions
Keywords
COVID-19, SARS-CoV-2, polyclonal IgG
Brief summary
The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.
Interventions
DRUGXAV-19
150 mg of XAV-19 single IV perfusion
DRUGPlacebo
Single IV infusion
Sponsors
Xenothera SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This is a phase II/III, multicenter, international, randomized (1:1), placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of XAV-19 in patients with moderate-to-severe COVID-19.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
I1) Male or female patient aged 18 years or over, weighing \>50 Kg and \<120 Kg, at the time of signing the informed consent, I2) Patient presenting in a specialized or an emergency unit I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea I4) Patient with SpO2 \> 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 pregnancy test at screening and use a highly effective 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.
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 | Description |
|---|---|---|
| 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-point ordinal scale at randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical parameters : Respiratory rate | Between randomization and Day 3, 5, 8 and 15 | breath/min |
| Change in Clinical parameters : SpO2 at ambiant air | Between randomization and Day 3, 5, 8 and 15 | — |
| Change in Clinical parameters : Supplemental O2 | Between randomization and Day 3, 5, 8 and 15 | L/min |
| Change in severity on Common Terminology Criteria of Adverse Events (CTCAE) scale (version 5.0) | Between randomization and Day 3, 5, 8 and 15 | Shortness of breath and thoracic pain Scale score : Dyspnea: grade 1 (shortness of breath with moderate exertion) to 5 (death) Non-cardiac chest pain: grade 1 (mild pain) to 3 (severe pain) |
| Duration of patient's requirement in supplemental O2 | up to 15 days | Time requiring supplemental O2 at Day 15 will be defined as the time in days from randomization to the date of requiring supplemental O2. |
| Duration of aggravation | up to 15 days | Duration of aggravation will be defined as the time in days between start date of aggravation and improvement date. |
| Length of hospital stay | up to 15 days | — |
| Viral status: RT-PCR or RT-qPCR for SARS-CoV-2 | At randomization and on Day 8 or at the end of follow-up, whichever comes first | (positive/negative) |
| Proportion of patients referred to Intensive Care Unit (ICU) | Between randomization and Day 3, 5, 8 and 15 | — |
| Change in Clinical parameters : body temperature | Between randomization and Day 3, 5, 8 and 15 | °C |
| Survival rates | at day 8 and day 15 after randomization | — |
| Safety: Occurrence of adverse effects | up to 15 days | Number and Proportion of participants with AE, SAE and treatment emergent adverse events leading to study drug discontinuation, to concomitant or additional treatment |
| Safety: hypersensitivity or allergy | up to 15 days | Incidence of hypersensitivity reactions and allergy |
| Safety: laboratories abnormalities : white blood cell count | up to 15 days | G/L |
| Safety: laboratories abnormalities : red blood cell count | up to 15 days | 10 12/L |
| Safety: laboratories abnormalities : hemoglobin | up to 15 days | g/dL |
| Safety: laboratories abnormalities : platelets | up to 15 days | G/L |
| Safety: laboratories abnormalities : creatinine | up to 15 days | µmol/L |
| Proportion of patients with need for mechanical ventilation | At randomization and at Day 3, 5, 8 and 15 | — |
Countries
Bulgaria, Greece, Romania, Spain, Turkey (Türkiye)
Outcome results
None listed