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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
Have diabetes
Have immunosuppressive disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks from monoclonal administration
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
6%
Blood creatine phosphokinase increased
5%
White blood cell count decreased
3%
Monocyte count decreased
2%
Neutrophil count decreased
1%
Nausea
1%
Aspartate aminotransferase increased
1%
Lipase increased
1%
Rash papular
1%
Blood alkaline phosphatase decreased
1%
Diabetic ketoacidosis
1%
Asthenia
1%
Blood lactate dehydrogenase increased
1%
Blood alkaline phosphatase increased
1%
Alanine aminotransferase increased
1%
Serum ferritin increased
1%
Arthralgia
1%
Epistaxis
1%
Lymphocyte count decreased
1%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Phase 2: 700 mg Bamlanivimab
Phase 2: 2800 mg Bamlanivimab
Phase 2: 7000 mg Bamlanivimab
Phase 3: Placebo
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Phase 2: Placebo

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

Frequently Asked Questions

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

What is the BAMLANIVIMAB FDA status?

"BAMLANIVIMAB's safety is estimated to be a 2. Although there is no data affirming its efficacy, Phase 2 trials provide some evidence that it is safe for human use."

Answered by AI

Are we still able to sign new patients up for this research?

"The clinical trial is still looking for participants and was first posted on 11/20/2020. The last time any information about the trial was edited was 3/14/2022 according to the website clinicaltrials.gov."

Answered by AI

How many individuals are being helped by this research?

"That is correct, the website clinicaltrials.gov has information indicating that this study is still recruiting patients. This trial was first posted on November 20th 2020 and updated as recently as March 14th of this year. They are looking to enroll a total of 1000 patients from 3 different locations."

Answered by AI

Are there precedents for BAMLANIVIMAB clinical trials?

"There are currently 6 clinical trials active for BAMLANIVIMAB, 4 of which have reached Phase 3. While Miami, Florida has several locations conducting these trials, there are a total of 617 sites across the world where research is being conducted."

Answered by AI

What are the standard conditions that BAMLANIVIMAB is used to treat?

"BAMLANIVIMAB is most commonly used as a treatment for patients with mild to moderate covid-19. It has also shown promise in treating other conditions such coronavirus disease 2019, laboratory-confirmed sars-cov-2 infection, and reducing the risk of hospitalization for patients with high risks of progressing to severe covid-19."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Sohail Rao 2020. "Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840459.
~231 spots leftby Apr 2025
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