What side effects are associated with this type of intervention?

Common treatments for COVID-19 include remdesivir, dexamethasone, convalescent plasma, and monoclonal antibodies. Remdesivir can cause side effects such as nausea, elevated liver enzymes, and potential kidney issues. Dexamethasone, a corticosteroid, may lead to hyperglycemia, increased risk of infections, and gastrointestinal bleeding. Convalescent plasma therapy has shown inconsistent benefits and may cause allergic reactions, transfusion-related acute lung injury, and volume overload. Monoclonal antibodies can result in infusion-related reactions, including fever, chills, and low blood pressure. COVID-19 vaccines, including those targeting variants, commonly cause mild side effects like injection site pain, fatigue, and fever, but severe reactions are rare.

What prior FDA approvals exist?

The FDA has granted emergency use authorization (EUA) for several monoclonal antibodies and mRNA vaccines for the treatment and prevention of COVID-19. Monoclonal antibodies, such as those developed for early treatment of mild to moderate COVID-19, have been authorized but many have faced challenges due to emerging variants. mRNA vaccines, like Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273, have been approved for their ability to induce strong humoral immune responses, similar to the goals of the SARS-CoV-2 variant vaccines being studied in the COVAIL trial.

What other types of research exist?

Promising novel alternatives to SARS-CoV-2 variant vaccines for inducing a humoral immune response in COVID-19 patients include monoclonal antibodies and convalescent plasma. Monoclonal antibodies can provide targeted neutralization of the virus, and convalescent plasma, sourced locally to match circulating variants, can offer passive immunity. Additionally, ongoing research into next-generation vaccines and immunomodulatory treatments may provide further options.

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mRNA Vaccine

COVID-19 Vaccines for Coronavirus

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 366

Awards & highlights

No Placebo-Only Group

Summary

This trial tests new doses of COVID-19 vaccines, including those for new variants, in healthy adults who have already received all initial doses. The goal is to see how well these additional doses improve the body's ability to fight the virus and its new versions. Booster doses help maintain protection.

Who is the study for?

Adults aged 18+ in stable health who've completed their primary COVID-19 vaccination series and booster at least 16 weeks prior can join. Those with stable chronic conditions may be eligible. Excludes pregnant/breastfeeding individuals, those with advanced liver/kidney disease, recent investigational vaccine or antibody therapy recipients, and people with certain medical histories like myocarditis.

What is being tested?

The COVAIL Trial is testing the safety and immune response to various prototype and variant COVID-19 vaccines (alone or combined) in adults previously vaccinated against SARS-CoV-2. It's an open-label trial where participants are randomly assigned to receive one of several variant vaccines.

What are the potential side effects?

Potential side effects include typical vaccine reactions such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea; rare risks may involve allergic reactions or heart inflammation known from other mRNA vaccines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 366 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Geometric Mean Fold Rise (GMFR)

Change from baseline in Geometric Mean Titers (GMT)

Change in Geometric Mean Ratio

Secondary study objectives

Incidence of Solicited Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

17Treatment groups

Experimental Treatment

Group I: Arm 17Experimental Treatment1 Intervention

100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in \> / = 49 years) N=100

Group II: Arm 16Experimental Treatment1 Intervention

100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.1) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in \> / = 49 years) N=100

Group III: Arm 15Experimental Treatment2 Interventions

500 mcg/mL CoV2 preS dTM-AS03 \[D614 + B.1.351\] (prototype + Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group IV: Arm 14Experimental Treatment2 Interventions

500 mcg/mL CoV2 preS dTM-AS03 \[B.1.351\] (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group V: Arm 13Experimental Treatment2 Interventions

500 mcg/mL CoV2 preS dTM-AS03 \[D614\] (prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group VI: Arm 12Experimental Treatment2 Interventions

500 mcg/mL of BNT162b2 (Omicron) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group VII: Arm 11Experimental Treatment2 Interventions

500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group VIII: Arm 10Experimental Treatment2 Interventions

500 mcg/mL of BNT162b2 (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group IX: Arm 09Experimental Treatment2 Interventions

500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group X: Arm 08Experimental Treatment3 Interventions

500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group XI: Arm 07Experimental Treatment1 Intervention

500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=50

Group XII: Arm 06Experimental Treatment3 Interventions

0.2 mg/ml of mRNA-1273.529 and mRNA-1273 0.2 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=100

Group XIII: Arm 05Experimental Treatment2 Interventions

0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=100

Group XIV: Arm 04Experimental Treatment3 Interventions

0.2 mg/ml of mRNA-1273.617.2 and 0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=100

Group XV: Arm 03Experimental Treatment3 Interventions

0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=100

Group XVI: Arm 02Experimental Treatment3 Interventions

0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=100

Group XVII: Arm 01Experimental Treatment2 Interventions

mRNA-1273 administered through 0.2 mg/ml intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\~45% in \> / = 65 years) N=100

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1273.351

2020

Completed Phase 2

~2070

mRNA-1273.617.2

2021

Completed Phase 3

~6680

mRNA-1273.529

2021

Completed Phase 3

~10230

CoV2 preS dTM/D614+B.1.351

2022

Completed Phase 2

~1270

BNT162b2 (B.1.351)

2022

Completed Phase 2

~1270

BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)

2022

Completed Phase 2

~1270

BNT162b2 (B.1.1.529)

2022

Completed Phase 2

~1270

BNT162b2 bivalent (wildtype and Omicron BA.1)

2022

Completed Phase 2

~1270

CoV2 preS dTM/D614

2022

Completed Phase 2

~1270

mRNA-1273

2021

Completed Phase 4

~58720

CoV2 preS dTM [B.1.351]

2022

Completed Phase 2

~1270

BNT162b2

2021

Completed Phase 4

~91160

AS03

2017

Completed Phase 2

~5460

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for COVID-19 include antiviral drugs, monoclonal antibodies, and vaccines. Antiviral drugs, such as remdesivir, inhibit viral replication by targeting viral RNA polymerase. Monoclonal antibodies, like those targeting the spike protein of SARS-CoV-2, neutralize the virus and prevent it from entering host cells. Vaccines, including those studied in the SARS-CoV-2 variant vaccine trials, aim to induce a robust humoral immune response by stimulating the production of neutralizing antibodies. This is crucial for COVID-19 patients as it helps to prevent severe disease, reduce viral load, and limit the spread of the virus.

TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.Reaction Cycles of Halogen Species in the Immune Defense: Implications for Human Health and Diseases and the Pathology and Treatment of COVID-19.Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.