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Phase 2 Completed N=1,755 Randomized Double-blind Treatment

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

Source: ClinicalTrials.gov NCT04634409 ↗
Enrolled (actual)
1,755
Serious AEs
0.7%
Results posted
Jul 2022
Primary outcomePrimary: Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 — 27.7; 12.2; 10.8; 7.8 percentage of participants — p=0.009273

Summary

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27
27.7; 12.2; 10.8; 7.8; 14.3; 7.9 0.009273 sig
PRIMARY
Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
9.9; 29.7 0.000835 sig
PRIMARY
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
12.0; 12.7; 19.8 0.097231
SECONDARY
Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
25.3; 12.0
SECONDARY
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
17.6
SECONDARY
Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
16.7; 0.0; 13.3
SECONDARY
Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
40.0; 16.7; 50.0; 0.0; 16.7; 33.3
SECONDARY
Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
25.0; 16.7; 0.0
SECONDARY
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
0.6; 0.0; 0.0; 0.0; 0.0; 0.0 0.769
SECONDARY
Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
SECONDARY
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
1.6; 2.4; 1.6 0.979
SECONDARY
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
3.0; 4.0
SECONDARY
Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
1.7
SECONDARY
Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-2.87; -3.54; -3.52; -3.13; -3.28; -3.74 0.009 sig
SECONDARY
Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-3.56; -2.74 0.002 sig
SECONDARY
Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-3.77; -4.00; -3.62 0.606
SECONDARY
Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-3.22; -3.43
SECONDARY
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-4.00
SECONDARY
Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-4.27; -4.39; -4.40; -4.49; -6.35; -4.76
SECONDARY
Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-3.47; -4.04; -3.40
SECONDARY
Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
-2.65; -4.90; -4.37
SECONDARY
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
29.0; 28.0; 36.9; 32.0; 41.0; 32.7 0.890
SECONDARY
Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
35.6; 29.7 0.374
SECONDARY
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
60.0; 50.8; 44.4 0.015 sig
SECONDARY
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
50.5; 52.0
SECONDARY
Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
47.2
SECONDARY
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
33.5; 45.1; 48.5; 46.5; 49.5; 52.4 0.082
SECONDARY
Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
43.6; 42.6 0.888
SECONDARY
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
34.9; 50.4; 46.8 0.014 sig
SECONDARY
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
42.4; 42.0
SECONDARY
Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
38.6
SECONDARY
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
1.9; 0.0; 0.0; 0.0; 1.0; 0.0
SECONDARY
Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
1.0; 0.0
SECONDARY
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
1.6; 2.4; 1.6
SECONDARY
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
6.0; 6.0
SECONDARY
Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
2.3
SECONDARY
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
30.0
SECONDARY
Pharmacokinetics (PK): Mean Concentration of Etesevimab
105
SECONDARY
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
4.18
SECONDARY
Pharmacokinetics (PK): Mean Concentration of VIR-7831
46.3

Eligibility Criteria

Inclusion Criteria

  • For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than ( 25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
  • Have chronic kidney disease
  • Have type 1 or type 2 diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Have cardiovascular disease (including congenital heart disease) or hypertension
  • Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
  • Have sickle cell disease
  • Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Have a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
  • Are currently not hospitalized
  • Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills
  • Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
  • Are men or non-pregnant women who agree to contraceptive requirements
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood
  • The participant or legally authorized representative give signed informed consent and/or assent

Exclusion Criteria

  • For low-risk participants only: BMI ≥35
  • Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation
  • Have known allergies to any of the components used in the formulation of the interventions
  • Have hemodynamic instability requiring use of pressors within 24 hours of randomization
  • Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
  • Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
  • Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
  • Have a history of a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test prior to the one serving as eligibility for this study
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
  • Have received treatment with a SARS-CoV-2 specific monoclonal antibody
  • Have a history of convalescent COVID-19 plasma treatment
  • For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
  • Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
  • Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Are pregnant or breast feeding
  • Are investigator site personnel directly affiliated with this study
  • Have body weight <40 kilograms
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04634409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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