Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-03-05 @ 3:46 AM
Study NCT ID:
NCT04840459
Status:
UNKNOWN
Last Update Posted:
2022-03-29
First Post:
2021-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711749', 'term': 'bamlanivimab'}, {'id': 'C000711487', 'term': 'casirivimab'}, {'id': 'C000711488', 'term': 'imdevimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine Rate of Recovery after monoclonal antibody therapy', 'timeFrame': 'six weeks from monoclonal administration', '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'}, {'measure': 'Determine if if Hospitalization occurred after monoclonal', 'timeFrame': 'six weeks from monoclonal administration', '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.'}], 'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'two weeks', 'description': 'Will record the number of participants who are prevented from progressing to sever infection.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing\n2. 12 years of age and older weighing at least 40 kg\n3. are at ":high risk" for progressing to severe COVID-19 and/or hospitalization\n\nHigh risk is defined as patients who meet at least one of the following criteria:\n\n1. Have a body mass index (BMI) \\>35\n2. Have chronic kidney disease\n3. Have diabetes\n4. Have immunosuppressive disease\n5. Are currently receiving immunosuppressive treatment\n6. Are over 65 years of age\n7. Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease\n8. Are 12 - 17 years of age AND have\n9. 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\n\nv. asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control.\n\nExclusion Criteria\n\n1. Younger than 12 years of age\n2. Do not meet criteria to be classified as "high risk\''}, 'identificationModule': {'nctId': 'NCT04840459', 'briefTitle': 'Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting', 'organization': {'class': 'OTHER', 'fullName': 'DHR Health Institute for Research and Development'}, 'officialTitle': 'Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting', 'orgStudyIdInfo': {'id': '1686206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAMLANIVIMAB', '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', 'interventionNames': ['Biological: BAMLANIVIMAB']}, {'type': 'EXPERIMENTAL', 'label': 'CASIRIVIMAB + IMDEVIMAB', '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', 'interventionNames': ['Biological: CASIRIVIMAB', 'Biological: IMDEVIMAB']}], 'interventions': [{'name': 'BAMLANIVIMAB', 'type': 'BIOLOGICAL', '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.', 'armGroupLabels': ['BAMLANIVIMAB']}, {'name': 'CASIRIVIMAB', 'type': 'BIOLOGICAL', 'description': 'CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.', 'armGroupLabels': ['CASIRIVIMAB + IMDEVIMAB']}, {'name': 'IMDEVIMAB', 'type': 'BIOLOGICAL', 'description': 'IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.', 'armGroupLabels': ['CASIRIVIMAB + IMDEVIMAB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sohail Rao, MD', 'role': 'CONTACT', 'email': 's.rao@dhr-rgv.com', 'phone': '956-362-2387'}, {'name': 'Monica Betancourt-Garcia, MD', 'role': 'CONTACT', 'email': 'm.betancourt@dhr-rgv.com', 'phone': '9563623223'}, {'name': 'Sohail Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marissa Gomez-Martinez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Monica Betancourt-Garcia, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cristian Mercado, MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ronnie Ozuna, Pharm.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'DHR Health Institute for Research and Development', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sohail Rao, MD', 'role': 'CONTACT', 'email': 's.rao@dhr-rgv.com', 'phone': '956-362-2387'}, {'name': 'Monica Garcia-Betancourt, MD', 'role': 'CONTACT', 'email': 'm.betancourt@dhr-rgv.com', 'phone': '9563623223'}, {'name': 'Sohail Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marissa Gomez-Martinez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cristian Mercado, MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Monica Garcia-Betancourt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ronnie Ozuna, Pharm.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'DHR Health', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '78582', 'city': 'Rio Grande City', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sohail Rao, MD', 'role': 'CONTACT', 'email': 's.rao@dhr-rgv.com', 'phone': '956-362-2387'}, {'name': 'Monica Garcia-Betancourt, MD', 'role': 'CONTACT', 'email': 'm.betancourt@dhr-rgv.com', 'phone': '9563623223'}, {'name': 'Sohail Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marissa Gomez-Martinez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cristian Mercado, MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Monica Garcia-Betancourt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ronnie Ozuna, Pharm.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Starr County Memorial Hospital', 'geoPoint': {'lat': 26.37979, 'lon': -98.8203}}], 'centralContacts': [{'name': 'Sohail Rao, MD', 'role': 'CONTACT', 'email': 's.rao@dhr-rgv.com', 'phone': '9563622387'}, {'name': 'Monica Betancourt-Garcia, MD', 'role': 'CONTACT', 'email': 'm.betancourt@dhr-rgv.com', 'phone': '956-3623223'}], 'overallOfficials': [{'name': 'Sohail Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DHR Heath Institute for Research and Development'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohail Rao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'President and CEO', 'investigatorFullName': 'Sohail Rao', 'investigatorAffiliation': 'DHR Health Institute for Research and Development'}}}}