Enrollment Update:

27,232 participants enrolled

in the COVE Phase 3 Study as of Friday, September 25, 2020 at 5:00 pm ET
15,454 participants have received their second vaccination. 

 

View the Phase 3 COVE Study Protocol

 

Enrollment Trends by Week:

Enrollment Trend

Moderna’s Commitment to Diversity & Inclusion

With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study. The clinical research sites, with the support of the Company, are working within their local communities to reach a diverse population. Working together with collaborators, the Company hopes to achieve a shared goal that the participants in the COVE Study are representative of the communities at highest risk for COVID-19 and of our diverse society.

As of Friday, September 25, 2020, approximately 31% of participants enrolled cumulatively are from diverse communities.

Study OverviewCove Study

The COVID-19 pandemic has altered each and every one of our lives. Mostly because to date, no effective vaccine to prevent COVID-19 has been found. Clinical research studies and volunteer study participants are vital to creating a vaccine that will prevent this devastating disease.

Moderna, the National Institutes of Health (NIH) and researchers in the COVE study are trying to find a solution to the current pandemic. The purpose of this study is to test Moderna’s vaccine candidate that may prevent illness after exposure to the SARS-CoV-2 virus, which causes COVID-19. By enrolling in this study, participants are contributing to a potential solution that could help to solve this global health crisis.

View a listing of clinical trial sites

About mRNA-1273, Moderna’s Vaccine Candidate Against COVID-19

Vaccines prepare the immune system to fight infections and prevent illnesses. Certain cells of the immune system produce antibodies (special proteins) that recognize viruses and other pathogens (things that cause disease) and make them harmless.

The vaccine being tested in this study is called mRNA-1273. The study team is testing if the vaccine can help the immune system produce effective antibodies against the SARS-CoV-2 virus so that, in case of infection, the virus does not cause illness.

Typical vaccines for viruses are made from a weakened or inactive virus, but mRNA-1273 is not made from the SARS-CoV-2 virus. It is made from messenger ribonucleic acid (mRNA), a genetic code that tells cells how to make protein, which help the body’s immune system make antibodies to fight the virus.

The vaccine cannot cause infection or make someone sick with COVID-19. Since March 2020, more than 300 people have received the vaccine so far with no serious side effects. More than 1,900 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. 

Cove Team

 

If you are interested in participating,

Click Here >

Study Participation Overview

While enrolled in the COVE study, participants will need to attend study visits and comply with study requirements, which include completing diary entries and immediately contacting the study physician if they are experiencing symptoms of COVID-19. The study physician and the study team will provide participants with additional details and answer any questions.

Eligible participants must be:

(There are additional eligibility requirements, which the study physician can explain.)

  • Cake icon18+ Adults who are 18 years of age and older
  • Shield iconNew to Studies Free from prior exposure to an investigational vaccine or treatment for COVID-19
  • Two People iconHigh Risk At high risk of COVID-19 infection (defined as adults whose locations or circumstances put them at greater risk of exposure to the virus responsible for COVID-19, or adults who are at high risk for severe COVID-19 based on age [65 years or older] or underlying medical conditions)
  • Temp iconHealthy Healthy adults with no previous history of COVID-19, or adults with pre-existing medical conditions that are stable, at the time of screening

What's involved

The total length of participation is up to 25 months and includes approximately six visits to the study site and 25 phone calls.

  • Shield Cross icon2 Injection VisitsParticipants will have two injection visits, which will happen on the first day and one month later. Participants will get their assigned injections of the study vaccine or placebo. Each participant has a 50% chance of receiving the study vaccine and a 50% chance of receiving the placebo.
  • Phone iconFrequent MonitoringParticipants will be contacted by the study team three times after each injection and then monthly after that to monitor for COVID-19 symptoms. During these phone calls, the study team will check how each participant is feeling and ask for updates on their health.
  • Calendar icon3 Return VisitsParticipants will be asked to return to the study site three more times over approximately a year.
  • Ipad iconWeekly DiariesParticipants will also be asked to complete weekly electronic diary entries reporting any COVID-19 symptoms for the duration of the study.
  • Briefcase Cross iconFinal VisitParticipants will have one final visit to the study site approximately two years from the date of their second injection.
Additional COVE Study Information
About the Placebo

In order to understand if the study vaccine is effective in preventing the COVID-19 illness or SARS-CoV-2 infection, researchers are comparing the study vaccine to a placebo. A placebo generally looks just like the study drug or study vaccine being tested but contains no active medication or vaccine.

Participants will receive the same level of care from the study team regardless of if they are assigned to the study vaccine or the placebo. Participants will also be closely monitored by the study team if they do have symptoms of COVID-19 at any time throughout their participation.

COVID-19 Diagnosis

If a participant is diagnosed with COVID-19 during their participation, the study team will provide them with frequent monitoring because the health and safety of all study participants are our top priorities.

If diagnosed, participants will have two illness visits, which will occur at the study site. They will also need to attend daily telemedicine visits by videoconference or over the phone for 14 days after the diagnosis visit or until their symptoms have resolved, whichever is later. If a participant is unable to attend a site visit as a result of their health or the coronavirus pandemic, the study team may perform a home visit.

Withdrawing from the COVE Study

Participants have the right to withdraw from the study at any time for any reason. The study doctor or Moderna also has the right to discontinue a participant at any time in the interest of the participant’s safety, or if the participant does not continue to meet eligibility requirements.

 

Cove people 2Cove people 1

Thank you for your interest in the COVE study. Your participation could make a world of difference.

To learn more, click here

 

mRNA-1273 Phase 3 Clinical Trial Sites
 

Institution Name

Institution Location

AB Clinical Trials

Las Vegas, Nevada, 89119

Accel Research Site

DeLand, Florida, 32720

Advanced Clinical Research – Be Well MD

Cedar Park, Texas, 78613

Advanced Clinical Research - Rancho Paseo

Banning, California, 92220

Alliance for Multispecialty Research

Newton, Kansas, 67114

Alliance for Multispecialty Research

Knoxville, Tennessee, 39720

Alliance for Multispecialty Research- East Wichita

Wichita, Kansas, 67207

Ascension St. Vincent Birmingham

Birmingham, Alabama, 35205

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205

Baylor College of Medicine

Houston, Texas, 77030

Benchmark Research - Austin

Austin, Texas, 78705

Benchmark Research - Fort Worth

Fort Worth, Texas, 76135

Benchmark Research - Metairie

Metairie, Louisiana, 70006

Benchmark Research - Sacramento

Sacramento, California, 95864

Benchmark Research - San Angelo

San Angelo, Texas, 76904

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Carolina Institute for Clinical Research - M3 Wake Research

Fayetteville, North Carolina, 28304

Centex Studies

McAllen, Texas, 78504

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

Cincinnati CRS

Cincinnati, Ohio, 45267

Clinical Research Atlanta

Stockbridge, Georgia, 30281

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229

Coastal Carolina Research Center

Mount Pleasant, South Carolina, 29464

Crisor

Medford, Oregon, 97504

DM Clinical Research

Tomball, Texas, 77375

DM Clinical Research - Texas Center For Drug Development

Houston, Texas, 77081

eStudySite - La Mesa

La Mesa, California, 91942

Foothill Family Clinic - North

Salt Lake City, Utah, 84109

Foothill Family Clinic-South Clinic

Salt Lake City, Utah, 84121

George Washington University

Washington, District of Columbia, 20037

Global Medical Research - M3 Wake Research

Dallas, Texas, 75224

Grady Health System

Atlanta, Georgia, 30303

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Henry Ford Health System

Detroit, Michigan, 48202

Hope Clinic of The Emory Vaccine Center

Decatur, Georgia, 30030

Hope Research Institute

Peoria, Arizona, 85018

Hope Research Institute

Chandler, Arizona, 85224

Hope Research Institute

Phoenix, Arizona, 85018

Jacksonville Center For Clinical Research

Jacksonville, Florida, 32216

Johnson County Clin-Trials

Lenexa, Kansas, 66219

Kaiser Permanente - Seattle

Seattle, Washington, 98101

Keystone VitaLink Research

Anderson, South Carolina, 29621

Keystone VitaLink Research - Greenville

Greenville, South Carolina, 29615

Keystone VitaLink Research - Spartanburg

Spartanburg, South Carolina, 29303

Laguna Clinical Research

Laredo, Texas, 78041

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112

Lynn Institute of The Rockies

Colorado Springs, Colorado, 80918

M3 Wake Research, Inc - M3 Wake

Raleigh, North Carolina, 27612

Medical Center For Clinical Research - M3 Wake Research

San Diego, California, 92108

MediSync Clinical Research Hattiesburg Clinic

Petal, Mississippi, 39465

Meridian Clinical Research

Dakota Dunes, South Dakota, 57049

Meridian Clinical Research

Omaha, Nebraska, 68134

Meridian Clinical Research

Rockville, Maryland, 20854

Meridian Clinical Research

Savannah, Georgia, 31406

Meridian Clinical Research

Binghamton, New York, 13901

Meridian Clinical Research-

Baton Rouge, Louisiana, 70808

Meridian Clinical Research

Grand Island, Nebraska, 68803

Meridian Clinical Research

Norfolk, Nebraska, 68701

New Horizons Clinical Research

Cincinnati, Ohio, 45242

New Jersey Medical School

Newark, New Jersey, 7103

Palm Beach Research Center

West Palm Beach, Florida, 33409

Paradigm Clinical Research Institute Inc

Redding, California, 96001

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104

Quality of Life Medical and Research Center

Tucson, Arizona, 85712

Rapid Medical Research Inc

Cleveland, Ohio, 44122

Research Centers of America

Hollywood, Florida, 33024

Saint Louis University

Saint Louis, Missouri, 63104

Suncoast Research Group

Miami, Florida, 33135

Sundance Clinical Research

St. Louis, Missouri, 63141

Tekton Research

Austin, Texas, 78745

Trial Management Associates

Wilmington, North Carolina, 28403

Tryon Medical Partners

Charlotte, North Carolina, 28210

UCLA Vine Street Clinic CRS

Los Angeles, California, 90038

UIC Project WISH CRS

Chicago, Illinois, 60612

University of California San Diego

La Jolla, California, 92093

University of Colorado Hospital

Aurora, Colorado, 80045

University of Maryland School of Medicine

Baltimore, Maryland, 21201

University of Miami

Miami, Florida, 33136

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555

UPMC-Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

VA Greater Los Angeles Healthcare

Veterans only

Los Angeles, California, 90073

Vanderbilt University Medical Center, Medical Arts Building

Nashville, Tennessee, 37232

Vanderbilt University Medical Center, Medical Center North

Nashville, Tennessee, 37232

Wake Forest University Health Sciences

Winston Salem, North Carolina, 27157

Weill Cornell Chelsea - (CRS)

New York, New York, 10010

Weill Cornell Medical College

New York, New York, 10065

WR-ClinSearch

Chattanooga, Tennessee, 37421

 

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