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A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
https://clinicaltrials.gov/ct2/show/NCT04445220

Jan 14th, 2022 - The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replace...

A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
https://clinicaltrials.gov/ct2/show/NCT04458298

Jan 14th, 2022 - The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Pati...

SARS-COV2 Pandemic Serosurvey in a Rare Disease Population
https://clinicaltrials.gov/ct2/show/NCT04609085

Jan 14th, 2022 - It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-COV2 virus, have a major impact on morbidity and mortality worldwide, as well as having devastating global economic and societal impact. During these outbreaks it is critical to gain a rapid understanding of the exposures and immunity in the general population. ...

Comparative Analysis of Anti-COVID-19 (Severe Acute Respiratory Syndrome) Humoral and Memory T Cell Responses in Children With Various Degrees of Immunosuppression:
https://clinicaltrials.gov/ct2/show/NCT04916847

Jan 14th, 2022 - Adaptive immune responses are essential for clearing viral infections and retention of virus specific memory populations is required for long-term immunity. However, there is still uncertainty about whether adaptive immune responses to SARS-CoV-2 are protective. Such knowledge is of immediate relevance, as it will provide insights into immunity of SARS-CoV-2 infection and thus help define futur...

Women s Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH) Equity
https://clinicaltrials.gov/ct2/show/NCT04983251

Jan 14th, 2022 - This is a cross-sectional population-based survey designed within a syndemic framework to characterize the impacts of the COVID-19 pandemic on women in under-studied, under-represented, and under-reported (U3) populations. We hypothesize that U3 women are experiencing and will have experienced a worsening of mental, physical, and socio-economic status as a result of the COVID-19 pandemic and th...

Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
https://clinicaltrials.gov/ct2/show/NCT04745351

Jan 14th, 2022 - The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).

Safety and Immunogenicity of a SARS CoV 2 Multivalent RNA Vaccine in Healthy Participants
https://clinicaltrials.gov/ct2/show/NCT05004181

Jan 14th, 2022 - This trial consists of two parts, Part A and Part B, and will evaluate the safety and immunogenicity of a third booster injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who have received two doses of the parent vaccine BNT162b2 ...

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults
https://clinicaltrials.gov/ct2/show/NCT05011526

Jan 14th, 2022 - The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study in...

Asunercept in Patients With Severe COVID-19
https://clinicaltrials.gov/ct2/show/NCT04535674

Jan 14th, 2022 - This is an open-label, randomized, phase II study with the main objective to investigate the effectiveness and safety of an investigational drug (APG101; International Nonproprietary Name: asunercept) in patients with severe COVID-19 disease. The study aims to decrease overall and SARS-CoV-2 associated pneumonia mortality in patients with COVID-19 as well as to decrease the percentage of patien...

Effect of the COVID-19 Public Health Crisis on the Mental Health and Physical Well-Being of Cancer Patients, the Coping With COVID Study
https://clinicaltrials.gov/ct2/show/NCT04652505

Jan 14th, 2022 - PRIMARY OBJECTIVE: I. To determine how the coronavirus disease 2019 (COVID-19) public health crisis affected mental well-being in cancer patients seen at the psychiatric oncology clinic. SECONDARY OBJECTIVES: I. To determine how the COVID-19 public health crisis affected physical well-being and substance use in cancer patients seen at the psychiatric oncology clinic. II. To determine how patien...

The COVID-19 and Healthcare Workers: An Active Intervention
https://clinicaltrials.gov/ct2/show/NCT04497415

Jan 14th, 2022 - Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world. To effectively respond to the COVID-19 outbreak, various governments have implemented rapid and comprehensive public health emergency interventions that include social restrictions and quarantines, which is the separation and restriction of movement of people who might have been exposed to the virus. While the p...

Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)
https://clinicaltrials.gov/ct2/show/NCT04496466

Jan 14th, 2022 - Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and SARS CoV-2, novel influenza viruses, viruses causing viral hemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, r...

Bucillamine in Treatment of Patients With COVID-19
https://clinicaltrials.gov/ct2/show/NCT04504734

Jan 14th, 2022 - This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be ...

Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
https://clinicaltrials.gov/ct2/show/NCT04493242

Jan 14th, 2022 - EXIT COVID-19 is a FDA-approved, phase II double-blinded, placebo-controlled randomized controlled trial that enrolled 120 patients admitted with COVID-19 associated moderate-to-severe ARDS across up to 15 hospital sites in the United States.

Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term
https://clinicaltrials.gov/ct2/show/NCT04836767

Jan 14th, 2022 - In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term ...

Pediatric COVID Outcomes Study (PECOS)
https://clinicaltrials.gov/ct2/show/NCT04830852

Jan 14th, 2022 - This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics...

Natural History Study of COVID-19 Using Digital Wearables
https://clinicaltrials.gov/ct2/show/NCT04927442

Jan 14th, 2022 - Covid-19 patients experience varying degrees of illness, ranging from no/mild symptoms to critical illness/death. A subset of covid-19 patients experiences long-term sequelae of covid-19 regardless of the severity of the disease initially. Predicting where a patient falls on the illness spectrum is important to allocate sparse resources and intervene medically at an optimal time. With current r...

A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid ...
https://clinicaltrials.gov/ct2/show/NCT04847050

Jan 14th, 2022 - Background: Cancer patients are at increased risk from COVID-19 infection fatality due to underlying malignancy, treatment-related immunosuppression, or increased number of comorbidities. In solid tumor patients, treatment with immune checkpoint inhibitor has been considered a potential predictor for severe disease. Similarly, patients with hematologic malignancies (acute leukemia, lymphoma, st...

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma
https://clinicaltrials.gov/ct2/show/NCT03170882

Jan 14th, 2022 - The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will compare the efficacy and safety in participants who take ixazomib and dexamethasone to pomalidomide and dexamethasone. It is an open-label, Phase 2 study. The study will enroll approximately 120 participants. Participants w...

The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change
https://clinicaltrials.gov/ct2/show/NCT04896060

Jan 14th, 2022 - We will recruit previous NIDDK study participants as well as newly recruited individuals from the general population to examine how the COVID-19 pandemic has exacerbated the impact of psychosocial stressors that impact eating behavior and weight. The study will describe the relationship between specific COVID-19 related stressors (e.g. fear of becoming sick) and self-rated measures of food inse...