NCT04884295

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

Terminated Phase 1, PHASE2 Last updated 15 April 2022

What this trial tests

Phase 1, PHASE2 trial testing XVR011 in Covid19 in 27 participants. Terminated before completion.

Timeline

26 August 2021

Primary endpoint
18 March 2022

18 March 2022

Quick facts

Lead sponsor	ExeVir Bio BV
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	26 August 2021
Primary completion	18 March 2022
Estimated completion	18 March 2022
Sites	6 locations across Belgium, Italy, Moldova

Drugs / interventions tested

• XVR011 — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

ExeVir Bio BV — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An affinity-enhanced, broadly neutralizing heavy chain-only antibody protects against SARS-CoV-2 infection in animal models.
   Schepens B, van Schie L, Nerinckx W, Roose K, et al · · 2021 · cited 59× · PMID 34609205 · DOI 10.1126/scitranslmed.abi7826
2. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants.
   Strohl WR, Ku Z, An Z, Carroll SF, et al · · 2022 · cited 31× · PMID 35476216 · DOI 10.1007/s40259-022-00529-7
3. Recent Progress in the Discovery and Development of Monoclonal Antibodies against Viral Infections.
   Mokhtary P, Pourhashem Z, Mehrizi AA, Sala C, et al · · 2022 · cited 26× · PMID 36009408 · DOI 10.3390/biomedicines10081861
4. Therapeutic Role of Neutralizing Antibody for the Treatment against SARS-CoV-2 and Its Emerging Variants: A Clinical and Pre-Clinical Perspective.
   Bhattacharya M, Chatterjee S, Mallik B, Sharma AR, et al · · 2022 · cited 12× · PMID 36298477 · DOI 10.3390/vaccines10101612
5. Nanoscale warriors against viral invaders: a comprehensive review of Nanobodies as potential antiviral therapeutics.
   Verma V, Sinha N, Raja A. · · 2025 · cited 10× · PMID 40201976 · DOI 10.1080/19420862.2025.2486390
6. Hyperimmune immunoglobulin for people with COVID-19.
   Kimber C, Valk SJ, Chai KL, Piechotta V, et al · · 2023 · cited 10× · PMID 36700518 · DOI 10.1002/14651858.cd015167.pub2
7. The Role of Antibodies in the Treatment of SARS-CoV-2 Virus Infection, and Evaluating Their Contribution to Antibody-Dependent Enhancement of Infection.
   Farouq MAH, Acevedo R, Ferro VA, Mulheran PA, et al · · 2022 · cited 5× · PMID 35682757 · DOI 10.3390/ijms23116078
8. Characterization of the VHH-Fc construct rimteravimab in healthy adults and patients hospitalized for mild-to-moderate COVID-19: Two Phase 1 randomized clinical trials.
   Jansen E, Bockstal V, Herschke F, Olsson Gisleskog P, et al · · 2026 · PMID 42213671 · DOI 10.1371/journal.pmed.1004609