COVID-19 Clinical Trial Recruitment supported through iConnect

29 Apr

COVID-19 Clinical Trial Recruitment supported through iConnect

by Erica Alshehabi

TrialX assists academic medical centers in recruitment for clinical research by offering iConnect, a patient friendly, centralized trial listing and recruitment platform. We proudly support research recruitment at Penn Medicine, Indiana CTSI, NYU and BIDMC.

Below is a list of COVID-19 trials currently being conducted. This list will be updated frequently to reflect new studies.

Last updated: June 4, 2020

COVID-19 clinical trials at Penn Medicine

Characterizing SAR-COV-2-Specific Immunity in Individuals who have Recovered from COVID-19

Summary: HVTN 405/HPTN 1901 will describe immune responses in study participants with a history of recovering from SARS- CoV-2 infection. A main aim of HVTN 405/HPTN 1901 is to develop antibody assays that can be reliably used to detect SARS-CoV-2 infection in vaccine and monoclonal antibody studies to prevent COVID-19. This information will be critical in illuminating the path to the development and testing of safe and effective vaccine and antibody interventions to prevent COVID-19.

Universal COVID-19 Biobank: A subset of the PENN MEDICINE Biobank

Summary: The overall purpose of the biobank is to collect and store biological specimens, such as blood, urine, respiratory specimens, other bodily fluids, and tissue where available, as well as health information. Storing these samples and this information allows researchers to use them for research studies, including but not limited to COVID-19.

Efficacy, Safety, and Tolerability Topical Nasal Spray in the Prevention of SARS-cov-2 Infection in Healthcare Personnel

Summary: This study will examine whether quinine topical nasal spray administered for 4 weeks is safe, tolerated, and can reduce the incidence of confirmed SARS-CoV-2 (also known as COVID-19) in health care professionals. 

Simple Mask Modification for Increased Protection during COVID-19

Summary: We plan to perform a prospective cohort study to study the fit factor of a modified surgical mask compared to that of a N95 mask and the unmodified standard surgical mask. In the process, we will also quantitatively characterize differences between masks.

Anonymous Survey on Confinement during the COVID-19 Pandemic (Dinges et al. UEP Survey 2020)

Summary: The purpose of the survey is to better understand the stresses of confinement and the strategies people are using to cope with confinement. You can contribute to that understanding by participating in this COVID-19 Confinement Survey.

Phase 1 Study of Convalescent Plasma for Severely ill Mechanically Ventilated Participants with COVID-19 Caused by SARS-CoV-2

Summary: The purpose of this study is to develop a possible new treatment for COVID-19 disease which uses antibodies against this virus. Antibodies are natural proteins made by the body that attack viruses and other germs. These antibodies are found in plasma, the yellow, clear part of the blood. 

Stem Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress

Summary: The main purpose of this research is to determine whether mesenchymal stromal stem cells are effective and safe in helping patients with moderate to severe ARDS due to COVID-19 infection. 

Plasmapheresis Donor Registry for Patients Recovered from Confirmed COVID-19

Summary: Study is seeking people who have recovered from COVID-19 and are willing to donate blood which will be used in a subsequent convalescent plasma study to transfuse into patients who are critically ill and on mechanical ventilator for COVID-19

Blood Donor Protocol for those Recovered from COVID-19, Suspected Exposure and Healthy Volunteers

Summary: Seeking blood donations from those with confirmed and suspected COVID-19 exposure for biobank storage.

A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Remdesivir for the Treatment of COVID 19 in Hospitalized Adults

Summary: This trial is investigating use of Remdesivir for treatment of COVID-19 patients currently admitted to hospital. Study is sponsored by Gilead Pharmaceuticals

The PATCH Trials: This trial is investigating use of Hydroxychloroquine, antimalarial treatment that has been widely discussed by American media. This study is split into 2 study groups:

Patients Quarantined at Home with COVID-19

Patients Hospitalized with COVID-19Healthcare Workers at Penn Medicine

COVID-19 DNA Vaccine Trial

Summary: Phase 1 study investigating safety of vaccine used to prevent COVID-19. Trial is sponsored by Inovio Pharmaceuticals. Penn Medicine is one of only two study sites recruiting for this trial.

REPLACE COVID-19 Study

Summary: The purpose of this study is to compare the effect of stopping versus continuing ACEI or ARBS in patients who have COVID-19. Patients must currently be admitted to hospital for COVID-19

COVID-19 Clinical trials at Indiana CTSI

Pilot study evaluating urine testing for COVID-19 and other diseases

Summary:

This study aims to invent a test that can see tiny pieces of infection in a person’s urine (specifically DNA and RNA from a person’s infection). We plan to find material of SARS-CoV-2, the virus causing Covid19.

Evaluation of the Emotional Effects of COVID-19 on People with and without Diabetes Study

Summary: We are looking for adults age 18 or older to complete an online questionnaire one per month for the next 12 months. The questionnaire will ask about your health history, your experiences and behaviors, and questions about your diabetes experience, if you have diabetes. Each questionnaire should take about 20 to 30 minutes to complete.

COVID-19 BLOOD SAMPLE COLLECTION

Summary: The Indiana Biobank is looking for volunteers who have recovered from COVID-19 and are willing to donate a blood sample to be used in research to improve testing and develop treatments for COVID-19. 

Tracking Asymptomatic COVID-19 Through Indianapolis Communities (TACTIC)

Summary: This study is seeking people and families who live in Marion County, Indiana to take a test for COVID-19. The goal is to determine how many people test positive but are asymptomatic.

COVID-19 Clinical trials at NYU

Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial

Summary: The purpose of this study is to understand if taking hydroxychloroquine (HCQ) may be used to help treat people infected with early SARS-CoV-2 infection.

Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients

Summary: The main purpose of this study is to determine if sarilumab is safe and if it can decrease the amount of time someone would have COVID-19 symptoms. Sarilumab (also known as Kevzara®) This study is for hospitalized COVID-19 patients. 

A randomized placebo-controlled safety and dose-finding study for the use of the IL-6 inhibitor clazakizumab in patients with life-threatening COVID-19 infection

Summary: The purpose of this research study is to investigate the safety of treatment with an investigational drug called clazakizumab compared to a placebo in critically ill patients who have been diagnosed with COVID-19 and have signs of respiratory failure.

Emergency Hyperbaric Oxygen for Respiratory Distress or Failure for COVID-19 Patients

Summary: The purpose of this study is to investigate the use of hyperbaric oxygen therapy to treat respiratory distress in patients who have tested positive for COVID-19 or have a clear clinical diagnosis of COVID-19 and may require mechanical ventilation. 

COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL (COLCORONA)

Summary:  The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19.

COVID 19 Intervention: Influence of ECMO on Cytokine Storm with/without Cytokine Filtration

Summary:  By studying the kinetics of the cytokine/immune storm in ARDS COVID patients pre and on ECMO we will be able to (1) describe the baseline time course of specific cytokine elevation and decrease, as well as effects on blood immune genes during ECMO therapy in anticipation of future trials which will involve studying whether in line interventions of cytokine filtration can reduce cytokines responsible for the ARDS.

A Randomized Trial of Anticoagulation Strategies in COVID-19:PROTECT-COVID 19

Summary: The purpose of the study is to compare a lower dose against a higher dose to reduce complications of blood clot formation in patients who are in the hospital due to COVID-19 infection. The drugs used in both regimens, heparin and enoxaparin, are Food and Drug Administration (FDA) approved for preventing clotting events.

Convalescent Plasma To Limit Coronavirus Associated Complications: A Randomized Blinded Phase 2 Study Comparing The Efficacy And Safety Of Anti-Sars-Cov-2 Plasma To Placebo

Summary: The purpose of the study is to find out if convalescent plasma (the liquid portion of blood of patients who recover from COVID-19) can prevent the development or reduce the severity of respiratory progression in people with COVID-19. This plasma will have substances that could improve the chances of recovery.

COVID-19 – Emergency IND

Summary: Prospective multicenter registry with an embedded open-label randomized clinical trial to determine the effects of standard of care treatment vs. standard of care plus AT-001 on cardiac structure and function and in-hospital survival in patients hospitalized for management of COVID-19 infection.

Dose-Finding Study to Describe the Safety Tolerability Immunogenicity and Potential Efficacy of SARS CoV 2 RNA Vaccine Candidates Against COVID 19 in Healthy Adults

Summary: The study will compare the results of the people who receive the study vaccine with those who receive a placebo (a placebo does not contain any active ingredients). Participants will be assigned to one of the groups investigating one of the study vaccines, at one of the vaccine dose levels.

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

Summary: The purpose of this research study is to see whether remdesivir (RDV) works against SARS-2-CoV. 

COVID-19 Clinical trials at BIDMC

Antiviral Activity of Remdesivir (GS-5734(TM)) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

Summary: The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.

Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

Summary: This is a two phase study: Phase 2 study objective is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of severity strata. Phase 3 is evaluating the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 (severe and critical).

Erica Alshehabi
Erica Alshehabi
erica@trialx.com

Erica brings more than 10 years of clinical research experience. She is well versed in clinical research coordination and management, especially within academic medical centers. Her strength is her knack for finding creative solutions for overcoming recruitment hurdles. Erica works directly with study teams to educate them on using the data driven recruitment metrics behind iConnect, where patients match with trials. She is an iConnect recruitment specialist focused on helping teams achieve target recruitment goals.

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