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A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals

NCT05210101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-08-15

Study results available
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Summary

This is an open-label study examining the safety and tolerability of sotrovimab, administered in two sequential doses as prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.

Conditions

  • SARS CoV 2 Infection

Interventions

DRUG

Sotrovimab

Two intravenous (IV) doses of sotrovimab were administered over the study period, the first 500mg, and the second 2000mg, in light of the reduced antiviral neutralization of sotrovimab against the BA.2 subvariant.

Sponsors & Collaborators

Principal Investigators

  • Sophia Koo, MD · Dana-Farber/Brigham and Women's Cancer Center

  • Jennifer Manne-Goehler, MD, ScD · Brigham and Women's Hospital

  • Sarah P Hammond, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210101 on ClinicalTrials.gov