Description
This is a phase 2, single-blinded, randomized trial of a single dose of Peginterferon Lambda-1a compared with placebo in outpatients with mild COVID-19. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care. The primary outcome will be duration of viral shedding in respiratory secretions by of SARS-CoV-2 qRT-PCR in 28 days of follow up.
Interferons are a group of cytokines that have antiviral activity. Interferon lamba is a type III interferon which primarily works on epithelial cells in the respiratory tract where SARS-CoV-2 replicates. Unlike other types of interferons, interferon lambda inhibits viral replication without being pro-inflammatory and does not trigger cytokine storm. This is ideal for treating COVID-19, since the most severe damage is caused by the inflammatory effects.
We are recruiting participants who have tested for positive for COVID-19 with mild symptoms who can be treated as outpatients. In addition to one dose of Peginterferon Lambda-1a or placebo, patients will receive serial testing to detect length of viral shedding in respiratory secretions, monitoring of clinical signs and symptoms, and will receive compensation for each visit. Participants must be 18-64 years of age and in generally good health.
Criteria
- Age 18-64; generally good health
- Ability to return to Stanford campus for follow-up visits
Participation Involves
- Half of the participants will be randomly chosen to receive the study drug and the other half will receive the placebo.
- Regular check for virus to tell you when it is gone
- Pulse oximeter and thermometer to check your blood oxygen levels and temperature every day at home
- Blood tests to see if you develop an immune response
- $40 compensation per study visit
Participant’s rights questions? Contact 1-866-680-2906
FAQ
- The medicine is usually well tolerated; we anticipate one treatment to be very safe
- You may have a small bump/lump at the injection site
- 10-20% of individuals may experience a small increase in liver enzymes but this is expected to return to normal quickly (within a few days)
- We will closely monitor your symptoms and your blood work after the injection
- The group that manages drug safety for humans (FDA) has given permission to use this drug to treat coronavirus
There is lab evidence that this medicine is active against coronavirus; but we need to find out if it works in humans. That is why we are doing this research study. Several other places around the world are also testing this medicine
- May help you feel better
- May help get rid of the virus so that you can return to work earlier
- May reduce your time in quarantine
- May help decrease spread of the virus to family members or friends
- The medicine may not work but the trial will tell us important results that can be useful to help the many people who get disease
- No
- Half the people will get drug and half will get a water/salt solution
- This is how most research on humans for drug treatment is done
- We hope the results of the trial will give important new information about how to treat coronavirus infections for the many people who get disease
- Closely monitor you every day
- You will get a thermometer and a pulse oximeter to monitor yourself each day
- We will check your virus levels regularly
- We will monitor your antibody levels at the end of the study
- You will be reimbursed $40 for each visit for your participation in the study
Email: treatcovid@stanford.edu | Phone: 650-721-9316
FAQ (Español)
- El medicamento es llamado Interferón-lambda (Lambda)
- Aumenta la respuesta inmune del cuerpo y esperamos que esta respuesta ayude a eliminar el virus
- Hay otro tipo de “interferones” que han sido usados en pacientes
- Este medicamento llamado Lambda es diferente a los otros interferones y tiene menos efectos secundarios.
- Este tratamiento es tolerado muy bien y anticipamos que una dosis sea segura
- Podría tener inflamación en el sitio de la inyección
- Sus síntomas serán monitoreados y tendrá análisis de sangre después de la inyección
- La agencia del gobierno (FDA) aprobó este medicamento para tratar el coronavirus que no están hospitalizados
- Pruebas de laboratorio han demostrado que este medicamento combate el coronavirus.
- Necesitamos saber si también funciona en humanos
- Esta es la razón por la cual estamos trabajando en este ensayo clínico
- Otros lugares en el mundo también están probando este medicamento en gente
- Puede ayudarle a sentirse mejor
- Puede eliminar el virus y ayudarle a regresar a su trabajo en menos tiempo
- Puede reducir los días de su cuarentena
- Puede reducir la transmisión del virus a los miembros de su familia
- Puede suceder que el tratamiento no sirva, pero los resultados de este ensayo clínico nos darán información importante para otros que contraen esta enfermedad
- No necesariamente
- La mitad de la gente que se inscriba recibirá la medicina y la otra mitad recibirá solución salina
- Este es un requerimiento de la mayoría de los ensayos clínicos
- Esperamos que los resultados de este ensayo clínico den información importante para poder curar las infecciones por coronavirus
- Lo chequearemos todos los días
- Le daremos un termómetro para checar su temperatura y un oximetro para monitorear sus niveles de oxígeno todos los días
- Revisaremos sus niveles virales regularmente
- Revisaremos sus niveles de anticuerpos al final de este estudio clínico
- Usted recibirá $40 por cada visita como reembolso por participar en este ensayo clínico.
Correo electrónico: treatcovid@stanford.edu | Teléfono: 650-721-9316
Please answer these two simple questions to see if you could qualify to participate in the trial.
Have you tested positive for coronavirus in the past 3 days?
Ha dado positivo por coronavirus en los últimos 3 días?
Bạn đã thử nghiệm dương tính với coronavirus trong 3 ngày qua?
在过去3天内,您是否检测过冠状病毒阳性?
Are you able to visit the Stanford campus for follow up visits?
Puede visitar el campus de Stanford para realizar visitas de seguimiento?
Bạn có thể đến thăm trường Stanford để theo dõi không?
您能够访问斯坦福大学校园进行后续访问吗?