BAMLANIVIMAB for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
CoronavirusBAMLANIVIMAB - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at the use of bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients.

Eligible Conditions
  • Coronavirus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Pfizer/BioNTech (BNT162b2)
1
LY3819253
1
AstroStem-V

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: six weeks from monoclonal administration

six weeks from monoclonal administration
Determine Rate of Recovery after monoclonal antibody therapy
Determine if if Hospitalization occurred after monoclonal
two weeks
Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Trial Safety

Safety Progress

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

Similar Trials

2
Pfizer/BioNTech (BNT162b2)
2
LY3819253
1
AstroStem-V

Side Effects for

4200mg Bamlanivimab
2%Urinary tract infection
1%Tooth abscess
1%Tooth infection
1%Contusion
1%Fall
1%Blood pressure increased
1%Back pain
1%Depression
1%Urticaria
1%Vertigo
1%Arthralgia
1%Pain in extremity
1%Dizziness
1%Rash
1%Atrial fibrillation
1%Palpitations
1%Constipation
1%Gastrooesophageal reflux disease
1%Sepsis
1%Hypertension
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04497987) in the 4200mg Bamlanivimab ARM group. Side effects include: Urinary tract infection with 2%, Tooth abscess with 1%, Tooth infection with 1%, Contusion with 1%, Fall with 1%.

Trial Design

2 Treatment Groups

BAMLANIVIMAB
1 of 2
CASIRIVIMAB + IMDEVIMAB
1 of 2

Experimental Treatment

1000 Total Participants · 2 Treatment Groups

Primary Treatment: BAMLANIVIMAB · No Placebo Group · Phase 2

BAMLANIVIMAB
Biological
Experimental Group · 1 Intervention: BAMLANIVIMAB · Intervention Types: Biological
CASIRIVIMAB + IMDEVIMABExperimental Group · 2 Interventions: CASIRIVIMAB, IMDEVIMAB · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: six weeks from monoclonal administration

Who is running the clinical trial?

Sohail RaoLead Sponsor
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Sohail Rao, MDPrincipal Investigator - DHR Heath Institute for Research and Development
DHR Health Institute for Research and Development
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are adults or pediatric patients with positive results of direct SARS-CoV-2 viral testing.
You are at high risk for progressing to severe COVID-19 and/or hospitalization.
You have chronic kidney disease.
You have an immunosuppressive disease.
You are over 65 years of age.
References

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