The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

Type: Interventional

Start Date: May 2020

open study

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).

Type: Interventional

Start Date: Jun 2020

open study

This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. Data collected will include participant medical histories, history of prior SARS-CoV-2 infection and exposure to known cases. On an ongoing basis data will be collected on new contacts with known cases, the presence of COVID-19 symptoms, including severity and outcome, and information on the immune system response to SARS-CoV-2 infection.

Type: Observational [Patient Registry]

Start Date: May 2020

open study

The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

Type: Observational

Start Date: Sep 2019

open study

The viral Covid-19 outbreak is now considered a pandemic according to the World Health Organisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developed to record and monitor the symptoms of the COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing are affecting the mental health and well-being of participants. The data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.

Type: Observational

Start Date: Mar 2020

open study

An informational evaluation of COVID-19 patients who receive low-level laser therapy in addition to a normal regimen of treatment for symptoms associate with COVID-19. Results are compared to statistical observations published in literature from patients receiving standard care for COVID-19 symptoms without low-level laser therapy.

Type: Observational

Start Date: Feb 2022

open study

Infection with bacteria or fungi can be deadly. Often, these types of infections can lead to an increase in the severity of illness requiring intensive care unit (ICU) admission, prolonged duration of treatment and further risks associated with additional infections and superinfections. These are also called hospital acquired secondary infections. Patients who contract COVID-19 and require an ICU admission are at increased risk of contracting these secondary infections, and receive certain medications that can lower your body's immune response. In COVID-19 patients who require these treatments, it is unclear what affect these medications can have on developing an additional infection as well as the rate of recovery/survival. This study is evaluating the effect these medications have on the development of secondary infections and rate of survival of COVID-19 patients that have been admitted to ICUs.

Type: Observational

Start Date: Feb 2022

open study

The aim of this study is to determine whether a community-informed, linguistically and culturally tailored educational program delivered via mobile phone is effective in improving vaccination behaviors among Latino families. Thus we evaluate a community-based mobile phone intervention (mivacunaLA) to assess if there is an increase in vaccination rates among 12-17 year old children and willingness to vaccinate 2-11year old children who have not been previously vaccinated who reside in high-risk and low resourced neighborhoods in Los Angeles.

Type: Interventional

Start Date: Jul 2021

open study

Despite their established benefits as public measures, vaccines continue to be treated with suspicion by many people, in the US and other parts of the world (Larson et al. 2014; Olive et al. 2018; Lazarus et al. 2020). Since the success of vaccines depends on their high uptake level (Anderson and May, 1985; Fine et al. 2011; Fontanet and Cauchemez, 2020), identifying factors that influence low trust and decision-making in relation to vaccines is essential in order to combat diseases such as the novel Coronavirus (COVID-19). The investigators study factors that could potentially influence public's trust in COVID-19 vaccines through a large-scale online field experiment. The investigators conduct an online survey of 32,400 subjects in nine countries (USA, Brazil, Mexico, China, India, Indonesia, Russia, Germany, and UK). The investigators study how willingness to receive the COVID-19 vaccine is affected by (1) the "novelty" of the vaccine technology (conventional vs. RNA vaccines), and (2) the adoption rate of the new vaccine in the country. That is - the impact of controversial science and the force of conformity on the rates of adoption. The latter will also allow us to calculate the "tipping point" adoption rate for each country that will allow the country to achieve herd immunity from COVID-19. The investigators have four hypotheses, below. H1 (Conformity): People are more willing to receive a vaccine as the cumulative adoption rate in their community increases. H2 (Novelty): People are less willing to get a COVID-19 vaccine that uses the new RNA technology, compared to a conventional vaccine H3 (Interaction between H1 and H2): As the cumulative adoption rate in a community increases, the difference between people's willingness to adopt conventional rather than RNA vaccines decreases. H4 (Tipping Point): Each country will have a different "tipping point". This is the cumulative adoption rate after which unvaccinated people are significantly more willing to get the vaccine. Countries that have a higher "honesty index" will have the tipping point appear at a lower cumulative adoption rate. Please note that this study is not a clinical trial. This study is a randomized controlled trial in the form of an online survey.

Type: Interventional

Start Date: Feb 2021

open study

This study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China. These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). This will be a prospective, single-center observational study involving human subjects. IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH). IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection. To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing. Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time. Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study. Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing. For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test. Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive. All testing will be performed in a two-week window. All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment. We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care. The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum. One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020. The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.

Type: Observational

Start Date: Aug 2020

open study

In order to safely and effectively reopen businesses and universities across the US, institutions will need to develop approaches to rapidly identify COVID-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability. This study will evaluate the implementation of a COVID-19 screening program that coordinates several existing systems at the University of Pennsylvania including saliva-based viral testing.

Type: Observational

Start Date: Sep 2020

open study

The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.

Type: Interventional

Start Date: Feb 2022

open study

The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.

Type: Interventional

Start Date: Jul 2020

open study

The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity and mortality in over 170 countries. Increasing age and burden of cardiovascular comorbidities are associated with a worse prognosis among patients with COVID-19. In addition, serologic markers of more severe disease including coagulation abnormalities and thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19 infection and are more common in patients who died in-hospital. As the COVID-19 pandemic continues to grow, there is a pressing need to identify safe, effective, and widely available therapies that can be scaled and rapidly incorporated into clinical practice. Understanding the putative mechanism of increased mortality risk associated with abnormal coagulation function and cardiac injury is critical to guide studies of promising therapeutic interventions. Published and anecdotal reports indicate that endothelial dysfunction and thrombosis are common in critically ill patients with COVID-19, including reports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys. Patients with cardiovascular disease (CVD) and CVD risk factors are known to have endothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19 inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mL was associated with an 18 times higher risk of in-hospital death, underscoring the importance of increased coagulation activity as a potential modifiable risk marker that may drive end-organ injury. Given the established link between endothelial dysfunction and thrombosis in patients with cardiovascular disease, and the association between coagulopathy and adverse outcomes in patients with sepsis, the association between increased coagulation activity, end-organ injury, and mortality risk may represent a modifiable risk factor among COVID-19 patients with critical illness. Therefore, we propose to conduct a randomized, open-label trial of therapeutic anticoagulation in COVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.

Type: Interventional

Start Date: May 2020

open study

The study will be a prospective cohort design to determine if children generate aerosols that harbor a viral load similar to adults. Prior to beginning enrollment, researchers may recruit up to 10 participants (adults or children who meet inclusion criteria for the main study) to perform a small pilot to optimize our cold chain and laboratory procedures. The study will include children and adults who are confirmed SARS-CoV-2 positive and aim for a total sample size of at least 10 children and 10 adults. Hypothesis: As children have a high viral load in the nasopharynx, we hypothesize that children generate aerosols that contain SARS-CoV-2 virus. Aim: To estimate the viral load in aerosols generated from children with COVID-19 infection, and to compare the viral load contained in aerosols from children with aerosols from adults

Type: Interventional

Start Date: Jan 2022

open study

This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.

Type: Interventional

Start Date: Nov 2021

open study

The purpose of this study is to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.

Type: Interventional

Start Date: May 2021

open study

This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.

Type: Interventional

Start Date: Apr 2021

open study

Approximately 20% of patients hospitalized with COVID-19 require intensive care and possibly invasive mechanical ventilation (MV). Patient preferences with COVID-19 for MV may be different, because intubation for these patients is often prolonged (for several weeks), is administered in settings characterized by social isolation and is associated with very high average mortality rates. Supporting patients facing this decision requires providing an accurate forecast of their likely outcomes based on their individual characteristics. The investigators therefore aim to: 1. Develop 3 CPMs in each of 2 hospital systems (i.e., 6 distinct models) to predict: i) the need for MV in patients hospitalized with COVID-19; ii) mortality in patients receiving MV; iii) length of stay in the ICU. 2. Evaluate the geographic and temporal transportability of these models and examine updating approaches. 1. To evaluate geographic transportability, the investigators will apply the evaluation and updating framework developed (in the parent PCORI grant) to assess CPM validity and generalizability across the different datasets. 2. To evaluate temporal transportability, the investigators will examine both the main effect of calendar time and also examine calendar time as an effect modifier. 3. Engage stakeholders to facilitate best use of these CPMs in the care of patients with COVID-19.

Type: Observational

Start Date: Dec 2020

open study

This study consists of two parts. Part A (Phase I): A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assess the Safety, Pharmacokinetics, Pharmacodynamics of MRG-001 Part B (Phase 2): A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Study in Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

Type: Interventional

Start Date: Dec 2021

open study

The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure. Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part. The name of the study drug involved in this study is: RLS-0071.

Type: Interventional

Start Date: Jan 2021

open study

"This is a prospective, multi-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis. Positive results from COVIDSeq Test using saliva and/or the comparator EUA test will be provided to subjects so participants can be referred for further evaluation (outside the study). No medical treatment, guidance on treatment decisions, nor medical care will be provided. "

Type: Observational

Start Date: Feb 2020

open study

The primary objectives are: - To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo - To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: - To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo - To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration - To assess the immunogenicity of REGN10933 and REGN10987

Type: Interventional

Start Date: Jul 2020

open study

The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.

Type: Interventional

Start Date: Jun 2020

open study

This is a standardized protocol for the rapid, coordinated clinical investigation of severe or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19) will be enrolled. This protocol has been designed to enable data and biological samples to be prospectively collected and shared rapidly in a globally-harmonized sampling schedule. Multiple independent studies can be easily aggregated, tabulated and analyzed across many different settings globally. The protocol is the product of many years of discussion among international investigators from a wide range of scientific and medical. Recruitment under this protocol has been initiated in response to Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral hemorrhagic fever (Ebolavirus) in 2014, Monkeypox & MERS-coronavirus in 2018, Tick-borne encephalitis virus (TBEV) in 2019 and COVID-19 in 2020. Participants may be newly identified through healthcare system or public health access, under quarantine, or in isolation care in outpatient or inpatient settings relevant to the Johns Hopkins University School of Medicine. Other locations may adopt this study concurrently, under a deferred review, or cooperatively. The existence of this protocol would ensure a timely, comprehensive epidemiologic and clinical characterization of the initial cases of COVID-19 in a mounting pandemic. The World Health Organization (WHO) recognized the need for standardized data collection for the epidemiology, immunology and clinical characteristics of these novel pathogens, and established the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) network in 2011. At the core of the protocol are a standardized schedule, structure and content of clinical, laboratory and microbiologic data collection, supplemented by domain-specific components (e.g., acute respiratory infection, viral hemorrhagic fever). The timepoints of this protocol will also be aligned with a separate multi-center institutional review board (IRB) approved protocol to describe patients with emerging infectious diseases that present to military treatment facilities within the United States.

Type: Observational

Start Date: Apr 2020

open study