Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19

Xenothera

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: XAV-19

Study type: Interventional

Funder types: Industry

Identifiers

NCT04928430

XT-2002

2020-005979-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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290 participants in 2 patient groups, including a placebo group

XAV-19

Experimental group

Description:

XAV-19

Treatment:

Drug: XAV-19

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo