Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-26

Study Completion Date

2022-03-18

Brief Summary

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This is a 2 part study where the first part (Phase 1) evaluates the safety of XVR011 and aims to identify the recommended Phase 2 dose. The second part (Phase 2) follows after the part 1 and evaluates whether XVR011 added to standard of care in patients hospitalised for mild to moderate COVID-19 is a safe, well tolerated, and effective treatment.

Part 1 (Phase 1) is completed as per protocol. The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Phase 1 is open-label, single ascending dose (completed per protocol); Phase 2 is double-blind, randomised, placebo-controlled (cancelled due to due to change in company strategy for phase II design)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XVR011

Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)

Group Type EXPERIMENTAL

XVR011

Intervention Type DRUG

Single dose of XVR011 via intravenous (IV) infusion

Interventions

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XVR011

Single dose of XVR011 via intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is ≥ 18 years of age.
* Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by RT-PCR and/or antigen test.
* Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable.
* Requires hospitalisation for medical care.
* Has oxygen saturation \>= 91%.

Exclusion Criteria

* Requires non-invasive or invasive mechanical ventilation and/or intensive care.
* Symptoms consistent with severe COVID-19.
* Has received a monoclonal antibody, plasma from a person who recovered from COVID-19 or any investigational treatment for COVID-19 within 30 days prior to study treatment.
* Has received an investigational or approved vaccination against SARS-CoV-2 within 14 days prior to study treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No