Lambda COVID-19 Study
HAVE YOU TESTED POSITIVE FOR CORONAVIRUS
(COVID-19) IN THE LAST TWO DAYS?
Are you interested in being in a Stanford research study of an investigational new treatment?
Please contact us as soon as possible after getting a positive Covid-19 test result as the study must start within 72 hours of the test being performed.
• Age 18-64; generally good health
• Ability to return to Stanford campus for follow-up visits
• 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
Frequently Asked Questions (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?
• Remdesivir was just approved by the government (Food and Drug Administration)
o only for treatment of patients in the hospital and must be given by vein
• There is no medication approved for patients outside the hospital
• That 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
o 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?
• 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?
• 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?
• 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?
• 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
o Closely monitor you every day
o You will get a thermometer and a pulse oximeter to monitor yourself each day
o We will check your virus levels regularly
o We will monitor your antibody levels at the end of the study
o You will be reimbursed $40 for each visit for your participation in the study.
Do you have any more questions?
• Email: email@example.com; Phone: 650-721-9316
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 More 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.
- NIH Clinical Trial Page
- Additional Articles
Interferon in the Press
(May 12, 2020) Dr. Prasanna Jagannathan talks with Raj Mathai of NBC Bay Area about the trial and the treatment.
(May 12, 2020) KCBS news anchor Susan Leigh Taylor spoke with Dr. Upinder Singh, co-leader of the study and professor of infectious diseases at the Stanford Medical School.
(May 12, 2020) Dr. Upinder Singh tells The Globe and Mail Canada that evidence the treatment clears the virus sooner than would may not only improve outcomes for patients but reduce transmission in the community.
(May 11, 2020) Scientists at Stanford Medicine are investigating whether a molecule called interferon-lambda can help people with mild cases of COVID-19 feel better and reduce their transmission of the disease-causing virus.
(May 13, 2020) Dr. Upinder Singh tells ABC7 News how interferon-lambda works by calling the body's natural immune system into action.