What side effects are associated with this type of intervention?

Hydroxychloroquine has been associated with gastrointestinal symptoms such as nausea and diarrhea, and in some cases, more severe cardiac issues like arrhythmias. Ivermectin, although initially considered, has shown no efficacy in high-quality trials and has been linked to neurologic adverse effects, especially when obtained without prescription. Fluvoxamine, an antidepressant, has not demonstrated significant benefits in high-quality trials and may cause side effects typical of SSRIs, such as nausea, dizziness, and sleep disturbances. It is important to consult with a healthcare provider to understand the risks and benefits of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including nirmatrelvir combined with ritonavir (Paxlovid) and remdesivir. Paxlovid is an oral antiviral that has shown efficacy in reducing the risk of hospitalization in non-hospitalized patients with COVID-19. Remdesivir, a nucleotide analog that inhibits SARS-CoV-2 RNA polymerase, is administered intravenously and is used for patients at risk of severe disease. These treatments are relevant to ongoing studies evaluating the necessity of testing asymptomatic pregnant women and informing prenatal care plans, as they provide options for managing COVID-19 in high-risk populations.

What other types of research exist?

Promising novel alternatives to SARS-CoV-2 testing for 2024 include CRISPR-based diagnostics, microarray techniques, and LAMP (Loop-mediated Isothermal Amplification) methods. These technologies offer rapid, reliable, and cost-effective testing options. CRISPR-based diagnostics can provide high specificity and sensitivity, while microarray techniques allow for the simultaneous detection of multiple pathogens. LAMP methods are advantageous due to their simplicity and speed. These alternatives can help address barriers to testing, such as cost and accessibility, and are particularly useful for asymptomatic pregnant women, ensuring timely and accurate prenatal care and counseling.

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COVID-19 Testing for Pregnancy (STOPCOVID19 Trial)

N/A

Waitlist Available

Led By Megan E Foeller, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of delivery

Summary

This trial aims to understand how COVID-19 affects pregnant women by checking their health and observing their well-being over time. It will help improve testing strategies and prenatal care plans to better support pregnant women during the pandemic.

Who is the study for?

This trial is for pregnant women without prior SARS-CoV-2 infection (unexposed group) and those with a viable pregnancy who have tested positive or developed antibodies during their current pregnancy (exposed group). Women with no viable intrauterine pregnancy or evidence of previous COVID-19 immunity are excluded.

What is being tested?

The study tests for the presence of SARS-CoV-2 through RNA, IgM, and IgG antibody testing in pregnant women. It aims to understand the necessity of asymptomatic disease testing in pregnancy and its impact on prenatal care plans.

What are the potential side effects?

Since this trial involves diagnostic testing rather than medication or vaccines, direct side effects from interventions are minimal but may include discomfort or bruising from blood draws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of delivery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of preterm delivery

Secondary study objectives

Confirmed congenital infection

Low birth weight

Percentage of infants with abnormal umbilical cord gas

+15 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Exposed (SARS-CoV-2 positive) cohortActive Control2 Interventions

Women who experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.

Group II: Unexposed (SARS-CoV-2 negative) cohortPlacebo Group1 Intervention

Women who do not experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.

Do I qualify?Apply below to find out

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 Coronavirus Infection, such as COVID-19, include antiviral medications, corticosteroids, and supportive care. Antiviral medications, like remdesivir, work by inhibiting the replication of the virus, thereby reducing the viral load in the body. Corticosteroids, such as dexamethasone, help reduce inflammation and modulate the immune response, which can prevent severe complications like acute respiratory distress syndrome (ARDS). Supportive care, including oxygen therapy and hydration, helps manage symptoms and maintain vital functions. These treatments are crucial for COVID-19 patients as they can reduce the severity of the disease, improve recovery times, and decrease mortality rates. Understanding these mechanisms is particularly important for managing high-risk populations, such as pregnant women, where tailored care and early intervention can significantly impact outcomes.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Recent discovery and development on SARS-CoV-2: A review of current literature.COVID-19: clinical issues from the Japan Surgical Society.