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Monoclonal Antibodies

Sotrovimab for COVID-19

Phase 2
Waitlist Available
Led By Sophia Koo, MD
Research Sponsored by Sophia Koo, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks after the first dose of sotrovimab
Awards & highlights

Study Summary

This trial is testing a new antibody medicine as a preventative measure for people with weakened immunity who are at high risk for contracting COVID-19.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks after the first dose of sotrovimab
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks after the first dose of sotrovimab for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with treatment-emergent adverse events, serious adverse events, and adverse events of specific interest
Serum sotrovimab levels to assess pharmacokinetics over time, with determination of AUC(0-∞) vs. dose
Serum sotrovimab levels to assess pharmacokinetics over time, with determination of area under the curve extrapolated to infinity (AUC(0-∞)
+7 more
Secondary outcome measures
Asymptomatic COVID-19 infection
Greatest extent of COVID-19 symptoms
Health-related quality of life
+2 more
Other outcome measures
Transplantation
New-onset allograft or stem cell failure requiring retransplantation in HCT recipients
New-onset or worsening graft-versus-host disease in hematopoietic cell transplant recipients

Trial Design

1Treatment groups
Experimental Treatment
Group I: SotrovimabExperimental Treatment1 Intervention
Two intravenous (IV) doses of sotrovimab were be administered in total - the first on Treatment Day 1 (500mg) and the second on Treatment Day 2, approximately 8-14 weeks after the first dose, at a higher 2000mg dose, in light of the reduced antiviral susceptibility of the BA.2 subvariant to sotrovimab, with the dosing interval determined by theoretical modeling of the duration of efficacy of sotrovimab as antiviral prophylaxis based on the rising prevalence of the Omicron BA.2 subvariant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotrovimab
FDA approved

Find a Location

Who is running the clinical trial?

Sophia Koo, M.D.Lead Sponsor
Massachusetts General HospitalOTHER
2,929 Previous Clinical Trials
13,198,212 Total Patients Enrolled
29 Trials studying COVID-19
10,060,556 Patients Enrolled for COVID-19
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,855 Total Patients Enrolled
2 Trials studying COVID-19
42,025 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the chief aims of this medical experiment?

"Through a 36-week evaluation, post the second administration of sotrovimab, this clinical trial will assess serum levels to calculate pharmacokinetics across different doses. Measuring asymptomatic COVID-19 infection rates and severe cases requiring hospitalization or death are secondary objectives while determining the most extreme symptoms on an 8 point NIAID-OS scale rounds out their primary goals."

Answered by AI

Are there any opportunities for applicants to join this clinical experiment?

"Affirmative. The information found on clinicaltrials.gov indicates that this medical trial is currently seeking participants. It was first published in the beginning of January 2022 and has been updated at the end of same month, with a total target recruitment size of 200 patients across 3 sites."

Answered by AI

What is the current enrollment of this research endeavor?

"Affirmative, clinicaltrials.gov states that this research is currently seeking participants. The trial was initially announced on January 31st 2022 and recently revised on the 26th of the same month. This study requires 200 subjects to be divided among three different sites."

Answered by AI

Has this remedy obtained clearance from the FDA?

"This treatment has been assigned a safety score of 2, as there are limited clinical data demonstrating its efficacy but some information that suggests it would be safe to use."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals
Sophia Koo, M.D. 2022. "A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05210101.
~29 spots leftby Apr 2025
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