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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840459
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Sohail Rao, DHR Health Institute for Research and Development

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: BAMLANIVIMAB Biological: CASIRIVIMAB Biological: IMDEVIMAB Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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'

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840459


Contacts
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Contact: Sohail Rao, MD 9563622387 s.rao@dhr-rgv.com
Contact: Monica Betancourt-Garcia, MD 956-3623223 m.betancourt@dhr-rgv.com

Locations
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United States, Texas
DHR Health Institute for Research and Development Recruiting
Edinburg, Texas, United States, 78539
Contact: Sohail Rao, MD    956-362-2387    s.rao@dhr-rgv.com   
Contact: Monica Betancourt-Garcia, MD    9563623223    m.betancourt@dhr-rgv.com   
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         
DHR Health Recruiting
Edinburg, Texas, United States, 78539
Contact: Sohail Rao, MD    956-362-2387    s.rao@dhr-rgv.com   
Contact: Monica Garcia-Betancourt, MD    9563623223    m.betancourt@dhr-rgv.com   
Principal Investigator: Sohail Rao, MD         
Sub-Investigator: Marissa Gomez-Martinez, MD         
Sub-Investigator: Cristian Mercado, MA         
Sub-Investigator: Monica Garcia-Betancourt, MD         
Sub-Investigator: Ronnie Ozuna, Pharm.D         
Starr County Memorial Hospital Recruiting
Rio Grande City, Texas, United States, 78582
Contact: Sohail Rao, MD    956-362-2387    s.rao@dhr-rgv.com   
Contact: Monica Garcia-Betancourt, MD    9563623223    m.betancourt@dhr-rgv.com   
Principal Investigator: Sohail Rao, MD         
Sub-Investigator: Marissa Gomez-Martinez, MD         
Sub-Investigator: Cristian Mercado, MA         
Sub-Investigator: Monica Garcia-Betancourt, MD         
Sub-Investigator: Ronnie Ozuna, Pharm.D         
Sponsors and Collaborators
Sohail Rao
Investigators
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Principal Investigator: Sohail Rao, MD DHR Heath Institute for Research and Development
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Responsible Party: Sohail Rao, President and CEO, DHR Health Institute for Research and Development
ClinicalTrials.gov Identifier: NCT04840459    
Other Study ID Numbers: 1686206
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bamlanivimab
Antiviral Agents
Anti-Infective Agents