mRNA-1273 for COVID-19

Phase-Based Estimates
1
Effectiveness
1
Safety
Optimal Research San Diego, LLC, San Diego, CA
COVID-19+1 More
mRNA-1273 - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether a vaccine made from messenger RNA (mRNA) may help prevent the flu.

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether mRNA-1273 will improve 3 primary outcomes and 3 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Up to Day 394 (1 year after second dose).

Day 394
GM of SARS-CoV-2-Specific Binding Antibody (bAb)
Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer
Day 36
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Year 1
Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Day 57
Number of Participants with Unsolicited Adverse Events (AEs)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

5 Treatment Groups

No Control Group
mRNA-1283 Dose Level 1
Placebo group

This trial requires 106 total participants across 5 different treatment groups

This trial involves 5 different treatments. MRNA-1273 is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

mRNA-1283 Dose Level 1
Biological
Participants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29.
mRNA-1273
Biological
Participants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29.
Placebo / mRNA-1283Participants will receive 1 IM injection of study drug-matching placebo on Day 1 and 1 IM injection of mRNA-1283 at a pre-specified dose on Day 29. Participants may be offered an opportunity to receive an additional injection of mRNA-1273 at the pre-specified dose on Open-Label Day 1.
mRNA-1283 Dose Level 3
Biological
Participants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29.
mRNA-1283 Dose Level 2
Biological
Participants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Moderna COVID-19 Vaccine
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 29, day 36, day 57, day 209, and day 394
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1, day 29, day 36, day 57, day 209, and day 394 for reporting.

Closest Location

Optimal Research San Diego, LLC - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person's body mass index (BMI) must be between 18 kg/square meter (kg/m^2) and 35 kg/m^2 at the Screening Visit (Day 0). show original
For female participants of childbearing potential: negative pregnancy test, agrees to use adequate contraception or abstain from all activities that could result in pregnancy for at least 28 days prior to the first injection, agrees to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding. show original
Agrees to comply with the study procedures and provides written informed consent. show original
The investigator finds that the subject is in generally good health and can comply with study procedures. show original
Key

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 common treatments for covid-19?

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There are many different treatments being used for covid-19, all depending on the patient. Treatment is based on symptom severity, immunity, and patient preference. There are multiple potential treatments. There is no one treatment that has been shown to work great for all people. There is no standard protocol for treatment. There are also many side effects from treatment, which can make decisions incredibly difficult for patients and their doctors. As this disease is under study there is not enough data to make long term treatment plans. Treatment for patients with covid-19 is focused on the specific patient.

Unverified Answer

What causes covid-19?

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Covid-19 is an infectious disease and should not be transmitted to others through sexual contact. It requires direct or close contact with either respiratory or gastrointestinal secretions or tissue from an ill person. These secretions can be collected through hand washing, which needs to be respected by healthcare workers and the public.

Unverified Answer

What are the signs of covid-19?

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Signs associated with viral pneumonia include fever, a cough, and a sore throat. The rash and gastrointestinal signs, though present in the vast majority of cases, vary widely in their manifestation.\n

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Can covid-19 be cured?

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There is currently a lack of effective treatments for Covid-19 which is a serious threat to public health globally. Results from a recent clinical trial support our preliminary experimental finding by implicating the antihistamine Loperamide as a potential treatment option against SARS outbreak. We also show the utility of our drug discovery paradigm in predicting and testing compounds with high therapeutic value in other viral and prion illnesses.

Unverified Answer

What is covid-19?

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Due to growing global public health concerns, we need to understand the underlying epidemiological, host and tissue factor (TF) related viral causes of disease. This is why we conducted an online survey using a combination of quantitative and qualitative techniques. In response, our survey has provided insights into the knowledge, attitudes, and practice of many medical professionals around an emerging zoonotic disease. The responses highlight that our professionals have limited knowledge around the disease, are not always satisfied or satisfied with their practice when dealing with an emerging public health concern. We need to understand why and what motivates good practitioners to embrace the practice of evidence-based medicine (EBM), especially in this challenging situation while ensuring health protection of the patients and the public.

Unverified Answer

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

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In this sample of the US population, the risk of getting a mild case of a common respiratory infection is 0% per year; this has also been found in other countries.

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Is mrna-1273 typically used in combination with any other treatments?

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Results from a recent paper demonstrated that MRC-1273 was commonly used as part of some treatments that are recommended by the Ministry of Health and Medical Education during 2019-2020 COVID-19 outbreak. The clinical use of MRC-1273 is limited by our study and will focus more research on this issue.

Unverified Answer

What are the common side effects of mrna-1273?

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Given the nature and the prevalence of RNA-1273 related side effects, it is crucial to report to the ClinicalTrials.gov and publish all adverse effects as adverse events. Furthermore, the drug information page of mrna-1273 should specify all side effects of RNA-1273 that accompany every treatment, especially regarding the dosage and time interval of administration.

Unverified Answer

Have there been other clinical trials involving mrna-1273?

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There are still more tests and therapies to go for patients. Some diseases are being studied more for their clinical signs and symptoms as compared with RNA interference-1273 and RNA interference (mice). We still need to make advancements. Results from a recent clinical trial of these studies can help other researchers to advance our understanding about this disease. Also, the results of these clinical trials can be reviewed so that we can find treatments that are more practical. As for the clinical trials that have been conducted so far, we need to increase our knowledge and speed up our advancements.

Unverified Answer

How serious can covid-19 be?

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We have no evidence of a detrimental effect of this new virus strain in healthy adults. If symptoms do develop, they are usually mild, and a short term course, unless there is any underlying health problem, is usual.

Unverified Answer

Who should consider clinical trials for covid-19?

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The vast majority of reported clinical trials on coronavirus-related disease reported outcomes such as disease severity. Further, the limited number of people tested in these studies suggests that only a minority will have the condition to warrant testing, thus limiting access for people who may benefit from clinical trials. Clinical trials are an expensive resource. The burden of covid-19 will be severe for a huge fraction of the infected population. Consequently, the willingness of patients, clinicians and insurers to participate in clinical trials is an important concern.

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Does mrna-1273 improve quality of life for those with covid-19?

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RNA-1273 in combination with a standard of care for patients infected with SARS-CoV-2 demonstrated acceptable safety and preliminary efficacy which is supported by the preliminary analysis of a larger multicenter randomized controlled trial of patients with severe disease (median age 69.2, male 84%). While additional larger analyses of RNA-1273 are anticipated, this small trial is a step towards that goal.

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