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

Sponsor
Sohail Rao (Other)
Overall Status
Recruiting
CT.gov ID
NCT04840459
Collaborator
(none)
1,000
3
2
26.3
333.3
12.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BAMLANIVIMAB
  • Biological: CASIRIVIMAB
  • Biological: IMDEVIMAB
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 20, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

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.

Outcome Measures

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. [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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'

Contacts and Locations

Locations

Site City State Country Postal Code
1 DHR Health Institute for Research and Development Edinburg Texas United States 78539
2 DHR Health Edinburg Texas United States 78539
3 Starr County Memorial Hospital Rio Grande City Texas United States 78582

Sponsors and Collaborators

  • Sohail Rao

Investigators

  • Principal Investigator: Sohail Rao, MD, DHR Heath Institute for Research and Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 12, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Mar 29, 2022