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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840459
• Other study ID #: 1686206
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2022
• Source: DHR Health Institute for Research and Development
• Contact: Sohail Rao, MD
• Phone: 9563622387
• Email: s.rao[@]dhr-rgv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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'

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.
• CASIRIVIMAB
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
• IMDEVIMAB
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.

Locations

Country	Name	City	State
United States	DHR Health	Edinburg	Texas
United States	DHR Health Institute for Research and Development	Edinburg	Texas
United States	Starr County Memorial Hospital	Rio Grande City	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sohail Rao

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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