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Monoclonal Antibodies

BAMLANIVIMAB for Coronavirus

Phase 2
Waitlist Available
Led By Sohail Rao, MD
Research Sponsored by Sohail Rao
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks from monoclonal administration
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing bamlanivimab or a combination of casirivimab and imdevimab to treat COVID-19 in high-risk patients. These treatments are special proteins that help the immune system block the virus from infecting more cells. The goal is to prevent mild or moderate COVID-19 from becoming severe.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Other study objectives
Determine Rate of Recovery after monoclonal antibody therapy
Determine if if Hospitalization occurred after monoclonal

Side effects data

From 2023 Phase 2 & 3 trial • 3307 Patients • NCT04427501
4%
Nausea
3%
Vomiting
3%
Pruritus
3%
Dizziness
2%
Maternal exposure during pregnancy
2%
Abortion induced
2%
Pregnancy
2%
Headache
2%
Pyrexia
1%
Aphthous ulcer
1%
Herpes virus infection
1%
Nasal congestion
1%
Cold sweat
1%
Insomnia
1%
Hypoglycaemia
1%
Rheumatoid arthritis
1%
Chest discomfort
1%
Hyperglycaemia
1%
Musculoskeletal chest pain
1%
Dyspnoea
1%
Chest pain
1%
Abdominal pain
1%
Animal bite
1%
Flushing
1%
Diarrhoea
1%
Chills
1%
Syncope
1%
Dry mouth
1%
Blood creatine phosphokinase increased
1%
Upper-airway cough syndrome
1%
Phlebitis
1%
Thrombocytosis
1%
Fatigue
1%
Hypersensitivity
1%
Blood bicarbonate decreased
1%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Placebo
Phase 2: 2800 mg Bamlanivimab
Phase 2: 7000 mg Bamlanivimab
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Phase 3: Placebo
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Phase 2: 700 mg Bamlanivimab
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: CASIRIVIMAB + IMDEVIMABExperimental Treatment2 Interventions
10 mL of casirivimab and 10 mL of imdevimab from each respective vial using two separate syringes and dilute together in the infusion bag containing 0.9% Sodium Chloride Injection
Group II: BAMLANIVIMABExperimental Treatment1 Intervention
The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes

Find a Location

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
~200 spots leftby Nov 2025
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