Sotrovimab for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
GSK Investigational Site, Athina, GreeceCoronavirus+5 MoreSotrovimab - Biological
Eligibility
No minimum age - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well sotrovimab works in young people with mild to moderate COVID-19 who are at risk of disease progression.

Eligible Conditions
  • Coronavirus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 3 Secondary · Reporting Duration: Baseline, at Day 5, Day 8 and Day 11

Day 11
Change from Baseline in viral load in nasal secretions measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)
Up to Day 29
Number of participants with development of severe and/or critical respiratory COVID-19 through Day 29
Number of participants with progression of COVID-19 through Day 29
Up to Week 12
Apparent volume of distribution during terminal phase (Vz) following administration of sotrovimab
Area under the serum concentration-time curve from time zero to infinity (AUC[0-inf]) following administration of sotrovimab
Bioavailability (F) following administration of sotrovimab
Body weight-adjusted serum clearance of sotrovimab
Clearance (CL) following administration of sotrovimab
Maximum observed concentration (Cmax) following administration of sotrovimab
Terminal elimination half-life (T1/2) following administration of sotrovimab
Time to reach Cmax (Tmax) following administration of sotrovimab
Up to Week 36
Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Cohort B: Participants receiving sotrovimab via Intramuscular administration
1 of 2
Cohort A: Participants receiving sotrovimab via Intravenous administration
1 of 2

Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Sotrovimab · No Placebo Group · Phase 2

Cohort B: Participants receiving sotrovimab via Intramuscular administration
Biological
Experimental Group · 1 Intervention: Sotrovimab · Intervention Types: Biological
Cohort A: Participants receiving sotrovimab via Intravenous administration
Biological
Experimental Group · 1 Intervention: Sotrovimab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotrovimab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, at day 5, day 8 and day 11

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,658 Previous Clinical Trials
7,950,199 Total Patients Enrolled
Vir Biotechnology, Inc.Industry Sponsor
23 Previous Clinical Trials
12,862 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,567 Previous Clinical Trials
6,134,225 Total Patients Enrolled

Eligibility Criteria

Age No minimum age - 18 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You currently have mild to moderate symptoms of COVID-19.

Frequently Asked Questions

Are medical professionals currently seeking participants for this research endeavor?

"Per the clinicaltrials.gov database, this clinical trial is actively recruiting participants at present and was initially posted on December 16th 2021 with a recent update of November 4th 2022." - Anonymous Online Contributor

Unverified Answer

Is the scope of this medical trial open to participants 55 and over?

"This clinical trial has stringent age requirements, with participants needing to be no younger than 0 days and no older than 18 years of age." - Anonymous Online Contributor

Unverified Answer

What is the scope of participants for this clinical research?

"Affirmative. According to the data accessible on clinicaltrials.gov, this medical study, that was inaugurated on December 16th 2021 is currently recruiting participants. For completion of the trial 72 patients must be recruited from 7 distinct facilities." - Anonymous Online Contributor

Unverified Answer

What medical conditions does Sotrovimab usually address?

"Sotrovimab is a medication utilized in cases of positive results from direct sarscov-2 viral testing, proclivity to progress towards severe Covid-19 and/or hospitalization, weight 40kg or more, as well as mild to moderate Covid-19." - Anonymous Online Contributor

Unverified Answer

Are there multiple locations where this experimentation is taking place?

"At present, this medical trial is recruiting participants from 7 different sites. Locations include Idaho Falls, Houston and Cullman amongst other centres. To alleviate the burden of travel for patients that choose to enroll in the study, it's recommended they select a clinic near them." - Anonymous Online Contributor

Unverified Answer

What criteria must a person fulfill to be eligible for this medical experiment?

"This research requires 72 subjects aged 0 Days to 18 years that have been confirmed with covid-19. Additionally, participants must meet one of the following criteria: be under 1 year old; suffer from diabetes mellitus; possess a genetic or metabolic disorder; obesity, cardiovascular disease, sickle cell anemia, pulmonary illness, neurological condition; immunocompromised state or baseline medical complexity (i.e. gastrostomy/jejunostomy dependence and usage of CPAP/BiPAP)." - Anonymous Online Contributor

Unverified Answer

Are there any other investigations that have utilized Sotrovimab?

"Presently, there are 4 clinical trials involving Sotrovimab that are in progress with two of them currently at Phase 3. Most of the experiments for this medication are based in Pretoria, Gauteng; however, it is also possible to participate across 270 other locations worldwide." - Anonymous Online Contributor

Unverified Answer

Has Sotrovimab gained the endorsement of the Food and Drug Administration?

"The safety profile of Sotrovimab was rated a 2, as it has been tested to some degree but there is no evidence demonstrating its efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.