Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: BAMLANIVIMAB; Biological: CASIRIVIMAB; Biological: IMDEVIMAB

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sohail Rao, MD; Phone Number: 9563622387; Email: s.rao@dhr-rgv.com
• Study Contact Backup: Name: Monica Betancourt-Garcia, MD; Phone Number: 956-3623223; Email: m.betancourt@dhr-rgv.com

Study Locations

• United States
  • Texas
    • Edinburg, Texas, United States, 78539
      • Recruiting
      • DHR Health Institute for Research and Development
      • Principal Investigator: Sohail Rao, MD
      • Sub-Investigator: Marissa Gomez-Martinez, MD
      • Sub-Investigator: Monica Betancourt-Garcia, MD
      • Sub-Investigator: Cristian Mercado, MA
      • Sub-Investigator: Ronnie Ozuna, Pharm.D
    • Edinburg, Texas, United States, 78539
      • Recruiting
      • DHR Health
      • Principal Investigator: Sohail Rao, MD
      • Sub-Investigator: Marissa Gomez-Martinez, MD
      • Sub-Investigator: Cristian Mercado, MA
      • Sub-Investigator: Ronnie Ozuna, Pharm.D
      • Contact: Monica Garcia-Betancourt, MD; Phone Number: 9563623223; Email: m.betancourt@dhr-rgv.com
      • Sub-Investigator: Monica Garcia-Betancourt, MD
    • Rio Grande City, Texas, United States, 78582
      • Recruiting
      • Starr County Memorial Hospital
      • Principal Investigator: Sohail Rao, MD
      • Sub-Investigator: Marissa Gomez-Martinez, MD
      • Sub-Investigator: Cristian Mercado, MA
      • Sub-Investigator: Ronnie Ozuna, Pharm.D
      • Contact: Monica Garcia-Betancourt, MD; Phone Number: 9563623223; Email: m.betancourt@dhr-rgv.com
      • Sub-Investigator: Monica Garcia-Betancourt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
2. 12 years of age and older weighing at least 40 kg
3. are at ":high risk" for progressing to severe COVID-19 and/or hospitalization

High risk is defined as patients who meet at least one of the following criteria:

1. Have a body mass index (BMI) >35
2. Have chronic kidney disease
3. Have diabetes
4. Have immunosuppressive disease
5. Are currently receiving immunosuppressive treatment
6. Are over 65 years of age
7. Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease
8. Are 12 - 17 years of age AND have
9. BMI >85th percentile for their age and gender based on CDC o growth charts, ii. sickle cell disease OR iii. congenital or acquired heart disease OR iv. neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR

v. asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control.

Exclusion Criteria

1. Younger than 12 years of age
2. Do not meet criteria to be classified as "high risk'

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAMLANIVIMAB; 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	Biological: BAMLANIVIMAB; n. Bamlanivimab is a recombinant neutralizing human mIgG1? monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region.
Experimental: CASIRIVIMAB + IMDEVIMAB; 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	Biological: CASIRIVIMAB; CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.; Biological: IMDEVIMAB; IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Will record the number of participants who are prevented from progressing to sever infection.	two weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine Rate of Recovery after monoclonal antibody therapy	Participants will complete a questionnaire that will ask them to answer when symptoms started and how long after monoclonal antibody therapy did participants begin to feel better	six weeks from monoclonal administration
Determine if if Hospitalization occurred after monoclonal	Participants will complete a questionnaire that will ask them how they felt after monoclonal antibody therapy and whether or not they required hospitalization. Medical records will be reviewed to confirm.	six weeks from monoclonal administration

Collaborators and Investigators

• Sponsor: Sohail Rao

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Bamlanivimab
• Other Study ID Numbers: 1686206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes