Clinical Research

The Office of Research supports the execution and management of clinical research, including clinical trials, at South Shore Hospital. Working across nearly all departments, the Office of Research supports both in-patient and out-patient research.

Below, please find examples of current and recent studies conducted at South Shore Hospital.

COVID-19 Research

In response to COVID-19, South Shore Hospital researchers are working to find ways to better understand and treat the disease, as well as assess other negative consequences of COVID-19.

Click the title of each study to learn more.

Project Status: Active

About this Study: The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.

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Project Status: Active

About this Study: The primary purpose of this study is to define Post-Intensive Care Syndrome in Family (PICS-F) members 3-4 months following a COVID-19 infected family member’s admission to the Intensive Care Unit, and to assess for symptoms of Post-Traumatic Stress Disorder in family members as the primary outcome, and symptoms of depression and anxiety as secondary outcomes. The study also aims to identify predisposing or mitigating exposures for PICS-F.

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Project Status: Active

About this Study: The purpose of this study is to evaluate the effect of baricitinib 4-mg once daily compared to placebo on disease progression in patients with COVID-19 infection.

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Project Status: Closed

About this Study: The purpose of this study is to provide expanded access of remdesivir to patients infected with COVID-19.

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Other Clinical Research Studies

The studies listed below are examples of current or recent projects conducted at South Shore Hospital.

Click the title of each study to learn more.

Research Area: Wound Care

Project Status: Active

About this Study: The purpose of this trial is to determine whether standard treatment of complicated diabetic foot ulcers (DFUs) combined with an investigational, topical agent results in greater likelihood of wound closure over 26 weeks compared with standard treatment alone. The trial will also compare differences between treatment groups and long term durability of wound closure.

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Research Area: Wound Care

Project Status: Active

About this Study: The purpose of this study is to compare the short-term effect of two different approved treatments for pressure ulcers. Willing participants are randomly selected to receive either a negative pressure wound therapy system or a standard wound dressing treatment. Participants will be followed for up to 9 days while they are in the hospital. Three-dimensional wound photos are used to measure the percent of change in the wound bed surface area before, during and after treatment.

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Research Area: Wound Care

Project Status: Active

About this Study: The purpose of this study is to evaluate the safety and efficacy of a skin graft product (GrafixPL Prime) on healing venous leg ulcers.  GrafixPL is made from human placental amniotic membrane. Consenting participants will be randomly assigned to the investigational product along with compression therapy or compression therapy alone. The outcomes are measured by the investigator’s evaluation of wound healing and confirmed by offsite evaluators reading 3D images of the wound, blinded to the treatment arm.

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Research Area: Sepsis; Septic Shock

Project Status: Closed

About this Study: The purpose of this study is to determine the impact of using a unique combination of steroids and vitamins on participants with sepsis, a life threatening response to an infection.  All consenting participants will receive usual care for their condition and the combination of intravenous vitamin C, vitamin B1 and hydrocortisone or matching placebos.  The care team is blinded to the treatment arm.  The outcomes are measured by objective assessments of organ failure and mortality within 3 months of treatment.

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Research Area: Trauma; Frailty

Project Status: Active

About this Study: The purpose of this study is to identify blood based biomarkers for frailty specifically related to the possible role of hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC) in trauma and recovery from trauma.

Research Area: Prenatal Screening

Project Status: Active

About this StudyThe purpose of this study is to collect blood specimens to develop a noninvasive prenatal test (NIPT) for identifying fetal chromosomal abnormalities.   Pregnant women who are undergoing invasive prenatal diagnostic testing are invited to participate. Results of the new NIPT will be compared to results of the diagnostic testing outcomes.

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Research Area: Maternal Medicine

Project Status: Active

About this Study: The purpose of this study is to contribute data to ongoing research activities focused on the identification of EKG waveform changes in the context of clinical conditions and maternal medicine use. This observational study also seeks to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes. 

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Research Area: Prenatal Screening

Project Status: Closed

About this Study: The purpose of this study is provide an external clinical validation of an inexpensive, reliable and easy to use prenatal screening blood test for Down syndrome (T21), fetal sex, trisomy 18 and trisomy 13, and sex chromosome aneuploidy in the late first and early second trimester of pregnancy. Pregnant women with no specific genetic risk factors seeking routine genetic screening are invited to participate.  No results are provided to the participants. Outcomes are measured by comparing the VALUE test results to the results of commercially available genetic testing.

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