What side effects are associated with this type of intervention?

Common treatments for COVID-19 include dexamethasone, hydroxychloroquine (HCQ), and azithromycin. Dexamethasone, a steroid, can cause psychiatric side effects such as depression, emotional lability, euphoria, insomnia, malaise, personality changes, and psychosis. Hydroxychloroquine is generally safe but nearly half of the patients did not improve, and it can cause side effects like gastrointestinal upset and cardiac issues. Azithromycin, when co-administered with HCQ, did not show improved outcomes and can cause gastrointestinal disturbances and potential cardiac toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including monoclonal antibodies and antiviral agents. Notably, tixagevimab plus cilgavimab (Evusheld) has been authorized for pre-exposure prophylaxis in immunocompromised individuals. Additionally, remdesivir has been widely used as an antiviral treatment. Monoclonal antibodies like bebtelovimab were also authorized but have variable efficacy against different SARS-CoV-2 variants. These treatments are similar to AZD3152, which is currently being studied for its safety and pharmacokinetics in healthy adults.

What other types of research exist?

Promising alternatives to AZD3152 for COVID-19 treatment in 2024 include dexamethasone, tocilizumab, and sarilumab, which have been conclusively shown to reduce mortality. Additionally, quercetin has shown potential in preclinical studies and some clinical evidence for reducing disease severity. AZD7442 (Tixagevimab-Cilgavimab) has also demonstrated significant efficacy in preventing COVID-19 with a good safety profile.

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Unknown

AZD3152 for COVID-19

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Participants have suitable veins for cannulation or repeated venipuncture

Healthy male or female participants

Must not have

Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy

Any known HIV or hepatitis B or C infection at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, days 15, 31, 91, 181, and day 365

Summary

This trial tests a new drug called AZD3152 to see if it is safe and how it behaves in healthy adults. The study will help understand how the drug moves and changes in the body.

Who is the study for?

Healthy adults who test negative for COVID-19, weigh between 45-110 kg with a BMI of 18-32. They must have good veins for injections and commit to follow-up for up to a year. Excluded are those with recent immunoglobulins or blood products, pregnant or non-abstinent women without contraception, abnormal lab values, recent SARS-CoV-2 infection, hypersensitivity to AZD3152 or EVUSHELD mAb therapy.

What is being tested?

The study tests the safety and body's handling (pharmacokinetics) of AZD3152 at various doses and administration methods (intramuscular injection and intravenous infusion) in healthy participants against a placebo control.

What are the potential side effects?

Potential side effects aren't detailed but may include reactions related to immune response due to the nature of monoclonal antibodies like AZD3152. Participants will be monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My veins can be used for repeated needle insertions.

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I am a healthy individual.

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My weight is between 45 and 110 kg, and my BMI is between 18 and 32.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a weak immune system or am taking medication that weakens my immune system.

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I do not have HIV or hepatitis B or C.

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I received a COVID-19 vaccine within the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, days 15, 31, 91, 181, and day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, days 15, 31, 91, 181, and day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, days 15, 31, 91, 181, and day 365 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Apparent total body clearance (CL/F) of AZD3152 (IM administration only)

Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)

Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152

+11 more

Secondary study objectives

Number of participants with anti-drug antibody (ADA) to AZD3152

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD3152 Dose Z (IV)Experimental Treatment1 Intervention

Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion.

Group II: AZD3152 Dose Y (IV)Experimental Treatment1 Intervention

Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion.

Group III: AZD3152 Dose Y (IM)Experimental Treatment1 Intervention

Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections.

Group IV: AZD3152 Dose X (IV)Experimental Treatment1 Intervention

Participants will receive dose X of AZD3152 on Day 1 as an IV infusion.

Group V: AZD3152 Dose X (IM)Experimental Treatment1 Intervention

Participants will receive dose X of AZD3152 on Day 1 as a single IM injection.

Group VI: Pooled placeboPlacebo Group1 Intervention

Participant will receive placebo on Day 1 either via IM injection or IV infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD3152

2023

Completed Phase 1

~100

0 / 6Eligibility criteria met

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

Common treatments for COVID-19 include antiviral agents and monoclonal antibodies. Antiviral agents like remdesivir inhibit the RNA-dependent RNA polymerase, essential for viral replication. Monoclonal antibodies target the spike protein of SARS-CoV-2, blocking its interaction with the ACE2 receptor and preventing viral entry into human cells. These treatments are vital as they reduce viral load, alleviate symptoms, and prevent disease progression, improving patient outcomes and reducing mortality.

Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.