search
Back to results

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

Primary Purpose

Covid19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BAMLANIVIMAB
CASIRIVIMAB
IMDEVIMAB
Sponsored by
Sohail Rao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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'

Sites / Locations

  • DHR Health Institute for Research and DevelopmentRecruiting
  • DHR HealthRecruiting
  • Starr County Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BAMLANIVIMAB

CASIRIVIMAB + IMDEVIMAB

Arm Description

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

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

Outcomes

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.
Will record the number of participants who are prevented from progressing to sever infection.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2021
Last Updated
March 14, 2022
Sponsor
Sohail Rao
search

1. Study Identification

Unique Protocol Identification Number
NCT04840459
Brief Title
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Official Title
Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sohail Rao

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BAMLANIVIMAB
Arm Type
Experimental
Arm Description
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
Arm Title
CASIRIVIMAB + IMDEVIMAB
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
BAMLANIVIMAB
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
CASIRIVIMAB
Intervention Description
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
Intervention Type
Biological
Intervention Name(s)
IMDEVIMAB
Intervention Description
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
Primary Outcome Measure Information:
Title
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.
Description
Will record the number of participants who are prevented from progressing to sever infection.
Time Frame
two weeks
Other Pre-specified Outcome Measures:
Title
Determine Rate of Recovery after monoclonal antibody therapy
Description
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
Time Frame
six weeks from monoclonal administration
Title
Determine if if Hospitalization occurred after monoclonal
Description
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.
Time Frame
six weeks from monoclonal administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing 12 years of age and older weighing at least 40 kg 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: Have a body mass index (BMI) >35 Have chronic kidney disease Have diabetes Have immunosuppressive disease Are currently receiving immunosuppressive treatment Are over 65 years of age Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease Are 12 - 17 years of age AND have 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 Younger than 12 years of age Do not meet criteria to be classified as "high risk'
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohail Rao, MD
Phone
9563622387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Betancourt-Garcia, MD
Phone
956-3623223
Email
m.betancourt@dhr-rgv.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
Organizational Affiliation
DHR Heath Institute for Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHR Health Institute for Research and Development
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Betancourt-Garcia, MD
Phone
9563623223
Email
m.betancourt@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
First Name & Middle Initial & Last Name & Degree
Marissa Gomez-Martinez, MD
First Name & Middle Initial & Last Name & Degree
Monica Betancourt-Garcia, MD
First Name & Middle Initial & Last Name & Degree
Cristian Mercado, MA
First Name & Middle Initial & Last Name & Degree
Ronnie Ozuna, Pharm.D
Facility Name
DHR Health
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Garcia-Betancourt, MD
Phone
9563623223
Email
m.betancourt@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
First Name & Middle Initial & Last Name & Degree
Marissa Gomez-Martinez, MD
First Name & Middle Initial & Last Name & Degree
Cristian Mercado, MA
First Name & Middle Initial & Last Name & Degree
Monica Garcia-Betancourt, MD
First Name & Middle Initial & Last Name & Degree
Ronnie Ozuna, Pharm.D
Facility Name
Starr County Memorial Hospital
City
Rio Grande City
State/Province
Texas
ZIP/Postal Code
78582
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Garcia-Betancourt, MD
Phone
9563623223
Email
m.betancourt@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD
First Name & Middle Initial & Last Name & Degree
Marissa Gomez-Martinez, MD
First Name & Middle Initial & Last Name & Degree
Cristian Mercado, MA
First Name & Middle Initial & Last Name & Degree
Monica Garcia-Betancourt, MD
First Name & Middle Initial & Last Name & Degree
Ronnie Ozuna, Pharm.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs