A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness | NCT04634409 | Trialant

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness | NCT04634409 | Trialant

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below

For high-risk participant arms 12 and 13 only:

-- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening

Are ≥65 years of age

Have a body mass index (BMI) ≥ 35

Have chronic kidney disease

Have type 1 or type 2 diabetes

Have immunosuppressive disease

Are currently receiving immunosuppressive treatment, or

Are ≥55 years of age AND have

cardiovascular disease, OR

hypertension, OR

chronic obstructive pulmonary disease or other chronic respiratory disease

For high-risk participant arms 12 and 13 only:

Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening

Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical\_charts.htm

Have sickle cell disease

Have congenital or acquired heart disease

Have neurodevelopmental disorders, for example, cerebral palsy

Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)

Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control

Have type 1 or type 2 diabetes

Have chronic kidney disease

Have immunosuppressive disease, or

Are currently receiving immunosuppressive treatment.

For high-risk participants arm 14 only:

Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age

Are adults (≥18 years of age) with BMI >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