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COVID-19 Clinical Trials

Trials
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients ho…
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation. 

Hospitalized adults (>18 years) with symptoms suggestive of COVID-19

Illness of any duration and laboratory-confirmed SARS-CoV-2 infection within 14 days

Requires low or high flow oxygen devices or non-invasive mechanical ventilation

Has not received 5 or more doses of remdesivir as treatment for COVID-19

Has not receive 6mg or more of dexamethasone in one day, on more than one day in the past 7 days

Taiwo, Babafemi OTaiwo, Babafemi O
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04280705 STU00212207
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Positive Affect Regulation sKills (PARK)

The Positive Affect Regulation sKills (PARK) Course is an online program that teaches positive emotion skills for individuals experiencing stress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g…

The Positive Affect Regulation sKills (PARK) Course is an online program that teaches positive emotion skills for individuals experiencing stress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g., loss of income, shortages of daily essentials, etc.). The program consists of 8 skills aimed at increasing the daily experience of positive emotion to help individuals cope with whatever stress they might be experiencing. The skills are presented over the course of 5 weeks and after learning each skill by reading through content on our platform, there is the opportunity to practice the skill on the platform as well.

•At least 18 years of age

•Speaks and reads English

•Able to access the online platform through their phone, a public device (i.e., at the library) or at home

•Lives in US

Moskowitz, Judith TedlieMoskowitz, Judith Tedlie
STU00212262
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COVID-19 Convalescent Blood BioBank (SeroCore)
Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate imm…
Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate immunologic responses over time.  Blood will be shared with other investigators to validate serologic testing assays and to facilitate vaccine development.  
Individuals who have recovered from COVID-19 are eligible for enrollment.  Patients will need to be confirmed to have had COVID-19 either through PCR testing or a positive antibody test prior to enrollment.  
Ison, Michael GIson, Michael G
  • Map it 676 N. Saint Clair St. Suite 940
    Chicago, IL
STU00212371
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NU COVID-19 INT20L02 - International registry on thoracic cancer patients with COVID 19 - TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion)
An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to …
An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to COVID-19 patients without cancer. The purpose of this registry is to collect clinical information like symptoms, treatments, and outcomes of thoracic cancer patients (NSCLC, SCLS, MPM, and TETs) with COVID-19 to help develop risk assessment strategies and treatment recommendations for thoracic cancer patients.

Participants 18 years or older who have a type of thoracic cancer; (Non-Small Cell Lung Carcinoma [NSCLC], Small CellLung Carcinoma [SCLC], Malignant Pleural Mesothelioma [MPM], or thymicepithelial tumor [TET]) and have also been diagnosed with COVID-19

Patel, Jyoti DPatel, Jyoti D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212311
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NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)
This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior …
This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.

Primary Aim:

To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

Secondary Aims:

To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.
Ma, ShuoMa, Shuo
  • Map it 251 E. Huron St.
    Chicago, IL
STU00212455
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Wearable sensor to monitor and track COVID-19-like signs and symptoms to develop better care strategies for COVID-19 pandemic
Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,cou…
Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for COVID-19 pandemic

Ages between 18-95 years old

Currently experiencing any COVID-like signs and symptoms such as fever, cough,shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusionor inability to arouse, bluish lips or face
Jayaraman, ArunJayaraman, Arun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212522
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A pilot study of use of oscillation and lung expansion (OLE) therapy in patients admitted for COVID-19 (Protocol # CR-RR-2020-002)
This study is being done to evaluate the use of the MetaNeb System as an airway clearance and lung expansion therapy for patients with COVID-19 who require high-flow oxyg…
This study is being done to evaluate the use of the MetaNeb System as an airway clearance and lung expansion therapy for patients with COVID-19 who require high-flow oxygen therapy. The MetaNeb System can be used for therapy when patients are on high-flow oxygen and may make it easier to clear sputum out of the lungs. This study will evaluate the effect of the therapy on how quickly patients recover and can leave the hospital.

Participants in this study will be:

  • Randomized to receive either the MetaNeb therapy in addition to their standard of care or standard of care treatment without the MetaNeb therapy
  • If randomized to MetaNeb, patients will receive treatment with the MetaNeb therapy for a maximum of 7 days (28 treatments) while receiving high-flow oxygen therapy.

  • At least 18 years old
  • Tested positive or person under investigation for COVID-19 infection
  • Treated with high-flow oxygen therapy
  • High-flow oxygen therapy initiated within the past 72 hours
  • Other exclusion criteria apply
Wolfe, Lisa FWolfe, Lisa F
  • Map it 201 E. Huron St.
    Chicago, IL
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
NCT04582214 STU00212652
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Screening for Coronavirus Antibodies in Neighborhoods (SCAN)
Inthe SCAN study, we are measuring how many people in the Chicagoland area haveantibodies to SARS-CoV-2 (the virus that causes COVID-19), how widespread theinfection has been in Chicago, and whether some neighborhoods had moreinfection than…
Inthe SCAN study, we are measuring how many people in the Chicagoland area haveantibodies to SARS-CoV-2 (the virus that causes COVID-19), how widespread theinfection has been in Chicago, and whether some neighborhoods had moreinfection than others. By taking part, you will help us find out how many peoplein specific areas have been exposed to SARS-CoV-2, and if these antibodiesprotect people against re-infection.

Adults age 18 years and older living in the Chicagoland area or Illinois.

McDade, ThomasMcDade, Thomas
STU00212472
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Effects of the COVID-19 Pandemic on Sexual and/or Gender Minority (SGM) Individuals and People with HIV (PWH)

Let’s find out the pandemic’s impact on the LGBTQ+ community and those living with HIV - by taking this national survey from home! The goal is to understand how COVID-19 and the U.S. r…

Let’s find out the pandemic’s impact on the LGBTQ+ community and those living with HIV - by taking this national survey from home! The goal is to understand how COVID-19 and the U.S. response impacts your community in order to help build better health care, policy, and support systems. - by taking this national survey from home!

The goal is to understand how COVID-

19 and the U.S. response impacts your community in order to help build better health

care, policy, and support systems.

We are looking for people who are LGBTQ+ and/or people who are HIV-positive to be in this study. You must be 18 years of age or older and a current resident of the United States to participate.
Phillips ii, GregoryPhillips ii, Gregory
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
STU00212293
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Circulating Endothelial Cells as Biomarkers of Cardiovascular Events in Patients with COVID-19
This study is recruiting patients who have been admitted to the hospital with a diagnosis of COVID-19. The purpose of this research study is to look at a new marker of inflammation that may predict worsenin…
This study is recruiting patients who have been admitted to the hospital with a diagnosis of COVID-19. The purpose of this research study is to look at a new marker of inflammation that may predict worsening clinical parameters or severe disease in patients with COVID-19
Akhter, NausheenAkhter, Nausheen
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212691
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ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

ACTIV-2/A5401 is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19.

This study is being done …

ACTIV-2/A5401 is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19.

This study is being done to rapidly and efficiently evaluate multiple potential therapeutics for COVID-19 in an outpatient setting.

Duration of study: 28 days of intensive follow-up, followed by limited follow-up through 24 weeks.

  • Outpatient (non-hospitalized) adult (18 years or older)
  • Positive COVID-19 test within 10 days prior to Entry
  • Onset of at least one typical COVID-19 symptom no more than 10 days prior to Entry, plus one the following symptoms present within 24 hours of entry:

–Fever or feeling feverish, cough, shortness of breath, sore throat, body or muscle pain, fatigue, headache,chills, nasal discharge or congestion, loss of taste or smell, nausea or vomiting, diarrhea

Taiwo, Babafemi OTaiwo, Babafemi O
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04518410 STU00213144
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COVID outpatient
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COVID Prevention Trials Registry
Afteryou provide consent, you will be asked to complete a survey to collect some informationabout your health and risk of exposure to COVID. The study team may contact you to assess yourpotential eligibility for COVID prevention trials when they open. You may open th…
Afteryou provide consent, you will be asked to complete a survey to collect some informationabout your health and risk of exposure to COVID. The study team may contact you to assess yourpotential eligibility for COVID prevention trials when they open. You may open the consent and registry survey in your web browser by clickingthe link below: COVID PreventionTrials Registry Consent . If thelink above does not work, try copying the link below into your web browser: https://is.gd/NUVaccineStudy
The NorthwesternCOVID Prevention Trials Registry is open to all adults who are interested inbeing contacted about upcoming COVID vaccine and other prevention studies.

TheCOVID vaccine trials will enrollpersonswhoareatrisk of infection and COVID-19 disease. This· · · - - - Racial/ethnic groups such as African Americans, Latinx, and NativeAmericanpopulations.

Krueger, Karen MKrueger, Karen M
STU00213110
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COVID
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COVID-19 TestUS an initiative of RADx AcceleRATeD study (Rapid Assessment of Technology for SARS-CoV-2 Detection)

We are studying the accuracy and usability of NEW point-of-care COVID-19 diagnostic tests compared to standard laboratory testing. You will be asked to come to our clinic for ONE visi…

We are studying the accuracy and usability of NEW point-of-care COVID-19 diagnostic tests compared to standard laboratory testing. You will be asked to come to our clinic for ONE visit to collect nasal swabs (less than one inch into each nostril) for new and standard tests. You will also complete surveys through a web browser, App on mobile device, or telephone interview with research staff. These surveys take approximately 30 minutes and they collect information on prior COVID-19 testing, COVID-19 exposures, demographics, and brief medical history.

Adults and children (over 10 years of age) with or without symptoms who are interested in getting tested for COVID-19 and willing to complete on-line or verbal surveys.

Murphy, Robert LeoMurphy, Robert Leo
  • Map it Arkes Pavilion, 676 N. Saint Clair St. Suite 940
    Chicago, IL
STU00213330
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FLUVOXAMINE FOR EARLY TREATMENT OF COVID-19: A FULLY-REMOTE, RANDOMIZED PLACEBO CONTROLLED TRIAL

STOP COVID Trial is a randomized controlled trial that aims to help slow the progression of COVID-19 symptoms in symptomatic patients in the United States. The study is contactless meaning vol…

STOP COVID Trial is a randomized controlled trial that aims to help slow the progression of COVID-19 symptoms in symptomatic patients in the United States. The study is contactless meaning volunteers may participate without leaving their home. Medication and study supplies are delivered by a courier or shipped overnight. We hope our study will demonstrate whether or not taking a medication, fluvoxamine, will help to prevent worsening of symptoms and prevent hospitalization.

You may be eligible if you:

  • Are age 30 or older
  • Tested positive for COVID-19
  • Are experiencing symptoms of COVID-19
  • Have current symptoms of COVID-19 that started within the past 6 days.
  • Have at least one of the following risk factors for developing serious COVID-19: age 40 or older, African-American, Hispanic/Latino, Native American, obesity, hypertension, or immune disease
  • Have not been vaccinated against COVID-19

You may be ineligible if you:

  • Are experiencing severe symptoms that require hospitalization
  • Are unable to take the study medication, fluvoxamine
  • Are taking one or more of the following medications: sertraline, donepezil, coumadin (warfarin), plavix (clopidogrel)

Rado, Jeffrey ThomasRado, Jeffrey Thomas
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT04668950 STU00213714
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A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults with COVID-19
Patients with COVID-19 disease are at risk of blood clots, which may affect many parts of the body. It is recommended that patient…
Patients with COVID-19 disease are at risk of blood clots, which may affect many parts of the body. It is recommended that patients hospitalized with COVID-19 disease be placed on a blood thinner called heparin to prevent clots. The purpose of this study is to determine if adding a platelet inhibitor, a different type of blood thinner, will be even better at reducing the risk of blood clots. All of these blood thinner medications are already approved by the United States Food and Drug Administration (FDA) for preventing clots in different situations. We do not currently know the best combination of these drugs in people hospitalized with COVID-19.

Participants in this study will receive an assigned study treatment that will last up to 14 days or until discharge from the hospital, whichever comes first. The study team will also contact participants about 90 days after hospital discharge and about 1 year after hospital discharge to check on the participant's health.

Currently, participants will be randomly assigned to either blood thinner alone or blood thinner with platelet inhibitor.

Participants may also optionally give blood samples at four different times during their hospital stay. The blood will be stored for future genetic research.

  • At least 18 years old
  • Hospitalized for COVID-19
  • Enrolled within 72 hours of hospital admission or 72 hours of positive COVID test
  • Expected to require hospitalization for more than 72 hours
  • Additional inclusion/exclusion criteria apply
Martin, Karlyn AMartin, Karlyn A
  • Map it 201 E. Huron St.
    Chicago, IL
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
NCT04505774 STU00213958
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Assessment of the Diagnostic Analyzer for Selective Hybridization (DASH) Point of Care Technology for Diagnosis of SARS-CoV-2 Infection
We are studying an innovative technology for diagnosing COVID-19 that is simpler, quicker, and at the point-of-care in a clinic.  You would be asked to fill out…
We are studying an innovative technology for diagnosing COVID-19 that is simpler, quicker, and at the point-of-care in a clinic.  You would be asked to fill out web-based forms/surveys on-line and then visit one of our clinical sites to have two nasal swabs collected from the front part of your nose by our study team.  These swabs will then be tested on our new technology, called DASH, and on a standard laboratory-based PCR test for COVID-19 virus.  We will be comparing how accurate and feasible our DASH test is compared to the standard PCR testing at diagnosing COVID-19.  You will be compensated for you time and parking at the study visit.
We are enrolling adults and children (10 years and older) with and without typical symptoms of COVID-19 who are willing to provide two nasal swab specimens for testing on our new technology and on a standard comparator.  Participants must be willing to answer questions/surveys using a web-based on-line system and come to one of our clinical sites for a single visit to have two nasal swabs collected.
Achenbach, Chad JAchenbach, Chad J
  • Map it 676 N. Saint Clair St. Suite 940
    Chicago, IL
  • Map it 675 N. Saint Clair St.
    Chicago, IL
STU00213905
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Immune response to SARS-CoV-2 vaccination in sarcoidosis
The purpose of this study is to investigate the antibody and immune responses to the COVID-19 vaccine in patients with sarcoidosis, both treated and not treated with immunosuppressive medications, compared to healthy controls. This study will …
The purpose of this study is to investigate the antibody and immune responses to the COVID-19 vaccine in patients with sarcoidosis, both treated and not treated with immunosuppressive medications, compared to healthy controls. This study will address a critical gap in our understanding of vaccine responses in people with sarcoidosis.

Participants will:

  • Complete a brief screening/health history questionnaire
  • Give 5-7 tubes of blood

Sarcoidosis Patients

  • At least 18 years old
  • Diagnosis of sarcoidosis and receiving care at Northwestern
  • Completed vaccination with the Pfizer (2 dose), Moderna (2 dose), or Johnson & Johnson (1 ose) vaccine for SARS-CoV-2 (COVID-19) at least 2 weeks prior to enrollment
  • If a vaccine booster was received, must have been received at least 2 weeks prior to enrollment

Controls

  • At least 18 years old
  • Completed vaccination with the Pfizer (2 dose), Moderna (2 dose), or Johnson & Johnson (1 ose) vaccine for SARS-CoV-2 (COVID-19) at least 2 weeks prior to enrollment
  • If a vaccine booster was received, must have been received at least 2 weeks prior to enrollment
  • Not diagnosed with an autoimmune disease, chronic lung disease, heart disease, or cancer
  • Not taking any immunosuppressive medications

Sporn, Peter HSporn, Peter H
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
STU00215567
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