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

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ClinicalTrials.gov Identifier: NCT04884295
Recruitment Status : Terminated (The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design. This early end of trial is not due to reasons of safety or lack of efficacy. Part 1 (Phase 1) is completed as per protocol.)
First Posted : May 12, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
ExeVir Bio BV

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: XVR011 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-part Clinical Study Including a First in Human, Open Label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double Blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date : August 26, 2021
Actual Primary Completion Date : March 18, 2022
Actual Study Completion Date : March 18, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XVR011
Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)
Drug: XVR011
Single dose of XVR011 via intravenous (IV) infusion




Primary Outcome Measures :
  1. Proportion of subjects with Adverse Events (all and serious) [ Time Frame: Through Day 29 ]
    Phase 1


Secondary Outcome Measures :
  1. Total duration of oxygen supplementation [ Time Frame: Through Day 29 ]
    Phase 1

  2. Proportion of subjects requiring mechanical ventilation and/or ICU transfer [ Time Frame: Through Day 29 ]
    Phase 1

  3. Proportion of subjects with COVID-19 related symptoms [ Time Frame: Through Day 29 ]
    Phase 1

  4. All-cause mortality rate [ Time Frame: Through Day 29 ]
    Phase 1

  5. Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples [ Time Frame: Up to Day 8/ Day of Discharge ]
    Phase 1

  6. Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) [ Time Frame: Through Day 29 ]
    Phase 1

  7. Time to hospital discharge [ Time Frame: Through Day 29 ]
    Phase 1


Other Outcome Measures:
  1. Maximum serum concentration (Cmax) [ Time Frame: Through Day 29 ]
    Phase 1

  2. Area under the serum concentration-time curve (AUC) [ Time Frame: Through Day 29 ]
    Phase 1

  3. Serum terminal elimination half-life (t1/2) [ Time Frame: Through Day 29 ]
    Phase 1

  4. Incidence of anti-drug antibody (ADA) to XVR011 [ Time Frame: Through Day 29 ]
    Phase 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

NOTE: Other protocol defined inclusion/exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884295


Locations
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Belgium
Investigative Site
Ghent, Belgium
Investigative Site
Liège, Belgium
Investigative site
Mechelen, Belgium
Italy
Investigative site
Milano, Italy
Investigative Site
Roma, Italy
Moldova, Republic of
Investigative site
Chisinau, Moldova, Republic of
Sponsors and Collaborators
ExeVir Bio BV
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Responsible Party: ExeVir Bio BV
ClinicalTrials.gov Identifier: NCT04884295    
Other Study ID Numbers: EXEVIR0101
2020-005299-36 ( EudraCT Number )
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases