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

What is Coronavirus?
＋
This is the virus that causes Covid-19 and is causing infections all across the world in 2020. The official name of this particular virus is “SARS-CoV-2”
Is there a drug to treat Coronavirus infections?
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Remdesivir was just approved by the government (Food and Drug Administration). It is only for treatment of patients who are sick enough to be in the hospital and must be given by vein. There is no medication approved for patients outside the hospital which is why we are working hard on this project.
What is the medication used in this trial?
＋
The medication is Interferon-lambda (Lambda). It helps the body increase its immune response, which we hope helps remove the virus. There are other types of drugs called “interferons” that have been used in patients. This particular drug (Lambda) is different from those other drugs and has significantly fewer side effects than other “interferons”.
Has this drug been given to people?
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Yes. The medicine has been given to healthy individuals and has been used to treat viruses that lead to liver problems (viral hepatitis). ~3000 people have been treated; for viral hepatitis most get treated for ~ 1 year
Will I be able to take the medicine without problems?
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  • 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
Does this medicine work against Coronavirus?
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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

How can this medicine help me?
＋
  • 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
Will I definitely get drug treatment?
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  • 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
If I’m not getting the drug, what is the benefit to me of being in the research study
＋
Even if you do not get the medicine, as a part of this research study, we will:
  • 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
Do you have any more questions?
Email: treatcovid@stanford.edu | Phone: 650-721-9316

FAQ (Español)

¿Qué es el Coronavirus?
＋
Es el virus que causa la Covid-19 y que en el 2020 ha ocasionado infecciones en todo el mundo. El nombre oficial de este virus específico es “SARS-CoV-2”
¿Existe tratamiento médico para curar las infecciones de Coronavirus??
＋
No hay un medicamento oficial o aprobado para pacientes tratados afuera de un hospital. El medicamento llamado Remdesivir es para uso exclusivo en hospitales y debe ser administrado en las venas sanguíneas.
¿Qué tipo de medicamento es utilizado en este ensayo clínico?
＋
  • 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.
¿Se ha administrado este medicamento en gente?
＋
Si. Esta medicina se le ha dado a gente saludable y se ha usado para tratar virosis que causan daño en el hígado (hepatitis viral). Cerca de 3,000 pacientes and sido tratados por hepatitis viral y el tratamiento dura cerca de un ano
¿Podre tomar este tratamiento sin problemas?
＋
  • 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
¿Este medicamento combate el Coronavirus?
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  • 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
¿Cómo me ayudara esta medicina?
＋
  • 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
¿Recibiré el medicamento si me inscribo en este ensayo clínico?
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  • 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
¿Qué beneficio tendré si me inscribo y no recibo la medicina?
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Aunque no reciba la medicina, como parte de este estudio de investigación:
  • 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.
¿Tiene alguna otra pregunta?
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?