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

March 14, 2022 updated by: Sohail Rao

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • 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:
        • Sub-Investigator:
          • Monica Garcia-Betancourt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: two weeks
Will record the number of participants who are prevented from progressing to sever infection.
two weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine Rate of Recovery after monoclonal antibody therapy
Time Frame: six weeks from monoclonal administration
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
Time Frame: six weeks from monoclonal administration
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohail Rao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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