mRNA-1273 for COVID-19

Phase-Based Estimates
1
Effectiveness
2
Safety
Velocity Clinical Research - Providence - ERN - PPDS, Warwick, RI
COVID-19+1 More
mRNA-1273 - Biological
Eligibility
< 18
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether a vaccine may help prevent the flu.

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Eligible Conditions

  • COVID-19
  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether mRNA-1273 will improve 12 primary outcomes and 7 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Day 149 (post third dose).

Day 394
GM Value of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb)
GM Value of SARS-CoV-2- Specific Neutralizing Antibody (nAb)
Day 394
GM of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb)
GM of SARS-CoV-2- Specific Neutralizing Antibody (nAb)
Day 514
Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation
Day 149
GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody
Seroresponse Rate of Post-Booster Dose of Vaccine Recipients
Month 1
Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody
Geometric Mean (GM) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody
Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19
Seroresponse Rate of Vaccine Recipients
Day 156
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 177
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 394
Number of Participants with SARS-CoV-2 Infection Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein in Participants with Negative SARS-CoV-2 at Baseline, in the Absence of Any COVID-19 Symptoms
Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Number of Participants with a First Occurrence of COVID-19
Year 1
Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis
Number of Participants with Medically-Attended AEs (MAAEs)
Number of Participants with Serious Adverse Events (SAEs)

Trial Safety

Trial Design

2 Treatment Groups

Placebo
mRNA-1273
Placebo group

This trial requires 13575 total participants across 2 different treatment groups

This trial involves 2 different treatments. MRNA-1273 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

mRNA-1273
Biological
Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at doses pre-specified for this study, 28 days apart, on Days 1 and 29. Part 1 participants will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for each age group, at least 6 months after Dose 2. Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1, 28 days apart, on Days 1 and 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for this age group, at least 6 months after Dose 2. Part 3: Participants will receive 2 IM injections of mRNA-1273 approximately 28 days apart (on Days 1 and 29) as the primary series followed by 1 IM injection as a third dose (on Day 149) at least 3 months after receipt of the second dose of the primary series. All 3 injections will be administered at the low dose that participants received during Part 1.
PlaceboPart 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366 for reporting.

Closest Location

Velocity Clinical Research - Providence - ERN - PPDS - Warwick, RI

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment. show original
Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow up, including all procedures, written informed consent is provided, and participants provide assent.
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29) and the third dose in Part 3 (Day 149/booster dose Day 1), and not currently breastfeeding.
Key
You have a body mass index at or above the third percentile according to WHO Child Growth Standards at the Screening Visit. show original
You are born at full-term with a minimum birth weight of 2.5 kg. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of mrna-1273?

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The side effects of mrna-1273 are almost no different than from those of placebo; side effects of mrna-1273 usually do not interfere with study completion.

Unverified Answer

What causes covid-19?

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At present, there is little evidence to support that exposure to an infected airborne droplet is a plausible cause of the current epidemic of coronavirus-associated illness. Further, a link between SARS-CoV-2 and a vaccine used during the 2013-2014 outbreak are currently not considered likely. Nevertheless, the fact that SARS-CoV-2 is a highly contagious respiratory illness, which disproportionately affects older populations, increases the risk of transmission within both healthcare and community settings where people live and work, and presents a substantial public health threat, a plausible causal role in the transmission of the disease to humans remains a theoretical possibility.

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Can covid-19 be cured?

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Despite recent advances in understanding the molecular mechanisms that are altered during the disease process, no known pharmacologic drugs have been approved for use in either a preventive or therapeutic fashion. Moreover, treatment efforts to reduce or eliminate the signs and symptoms of disease have failed to show substantial short-term or long-term efficacy. Therefore, these findings provide a strong rationale for the development of an effective therapy.

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What is covid-19?

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There are four major categories of symptoms in a person with coronavirus disease (COVID-19) as of the 14th February 2020: Fever and cough (40.4%), feeling tired for no clear reason (34.9%), fatigue (32.5%), loss of appetite (32.4%) and muscle (muscle aches and pains) pains (21.6%). A further 15.6% have symptoms from two or more categories. These conditions may overlap.

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How many people get covid-19 a year in the United States?

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Although only 1.9% of the American population (about 6.5 million) has been infected with this virus, some state and provincial health officials have announced plans to use statistical models to estimate an adult population infection that is close to 3%. In many jurisdictions, a significant number of people who show no symptoms may be at risk. Moreover, a small fraction of those infected will develop a serious, potentially deadly illness. Many public health authorities and the media are calling for states to adopt a wait-and-see approach, but some of the predicted infection rates in the United States are higher than those we currently see in other parts of the world.

Unverified Answer

What are the signs of covid-19?

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Covid-19 may cause the following symptoms:\n\n1. Fever and cough\n\n2. Nausea and vomiting\n\n3. Muscle pain\n\n4. Diarrhea\n\n5. Fever and shortness of breath\n\n6. Loss of appetite\n\n7. Lymph node or chest pain\n\n8. Muscle pain\n\nSource: https://www.cdc.gov/coronaviruse/\n\nThere is currently no cure for SARS. Treatment is symptom-based: Treating symptoms like fever and fatigue. Treatment is based on the person’s clinical symptoms.

Unverified Answer

What are common treatments for covid-19?

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The current Covid-19 outbreak is disproportionately affecting people with chronic psychiatric illnesses and cardiovascular risks and underlying health conditions that could have affected their response to the SARS virus. Recent findings support a potential role for treatment with antipsychotics and antiplatelet agents to optimize efficacy and limit possible interactions. Given the ongoing risk of drug interactions, appropriate monitoring of patients with chronic psychiatric illness, and those on antiplatelet agents, remains essential. More broadly, these findings highlight strategies for identifying and managing risk of drug interaction potential as health systems worldwide respond to this pandemic.

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What is the average age someone gets covid-19?

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Approximately 1 in 15 people in the United Kingdom have been infected with coronavirus SARS-CoV-2. This has caused the death of more than 50,000 people worldwide since a probable outbreak began in Wuhan, China. There is no evidence of sexual transmission of SARS-CoV-2. However, there is currently insufficient data comparing individuals and their risk of infection. Further research is needed.

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Have there been any new discoveries for treating covid-19?

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There has been great emphasis placed on research investigating antiviral, anti-inflammatory, and anti-cytokine treatments. This has led to the discovery of many promising products and vaccines as well as the development of an effective vaccine. However, there is still a huge gap in the research on catechols that target COV in which they display high efficacy with less toxicological effects. It is important that COV be discovered and developed for catechols not only since there are currently no catechols licensed for the treatment of COV, but also since it has been estimated that the development of catechols to treat COV is estimated to cost $30 million per year and $3.7 billion in total.

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Who should consider clinical trials for covid-19?

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The number of people who will benefit from clinical trials of potential treatments for SARS-CoV-2 will be higher in those with symptomatic infections or those with a risk of SARS-CoV-2 infection.

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What are the latest developments in mrna-1273 for therapeutic use?

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A large number of mrna-1273 therapeutics are under development. Although none have approved yet, there are at least three molecules on the market that are FDA-approved for use in cancer patients. For cancer patients with mrna-1273 therapy, there is an urgent need for an expanded, longer-term assessment of the safety of mrna-1273 molecules.

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What does mrna-1273 usually treat?

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The mRNA-1273 has shown to be effective with treating patients having influenza-like symptoms. In addition, the transcript is expressed in normal adult lung epithelial cells and in mouse peritoneal macrophage as well. Therefore, while mrRNA-1273 is effective, it may have further medical applications for treating inflammatory lung disease.

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