Enrollment Complete
30,000 participants enrolled
in the COVE Phase 3 Study as of Thursday, October 22, 2020.
25,654 participants have received their second vaccination.
View Demographic Data for the Phase 3 COVE Study
View the Phase 3 COVE Study Protocol
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.
Study Overview
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.
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. The vaccine cannot cause infection or make someone sick with COVID-19.
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.
Learn about mRNA-1273, Moderna's Potential Vaccine Against COVID-19
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.)
18+ Adults who are 18 years of age and older
New to Studies Free from prior exposure to an investigational vaccine or treatment for COVID-19
High 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)
Healthy 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.
2 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.
Frequent 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.
3 Return VisitsParticipants will be asked to return to the study site three more times over approximately a year.
Weekly DiariesParticipants will also be asked to complete weekly electronic diary entries reporting any COVID-19 symptoms for the duration of the study.
Final VisitParticipants will have one final visit to the study site approximately two years from the date of their second injection.
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.
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.
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.
Thank you for your interest in the COVE study. Your participation could make a world of difference.
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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