The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.

Type: Interventional

Start Date: Nov 2020

open study

The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesizes that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 40 and older who are hospitalized with moderate COVID-19 disease.

Type: Interventional

Start Date: Aug 2020

open study

Background: The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Researchers want to collect plasma from people who have recovered from COVID-19, and use this plasma to treat people who are sick with the disease. The plasma will have antibodies against the virus that causes COVID-19. Persons who have received a COVID-19 vaccine may also donate plasma that contains antibodies against the virus if they meet criteria according to the FDA. Objective: To collect plasma from people who have recovered from COVID-19 or have been vaccinated against the coronavirus that causes COVID-19, so that the plasma can be used to treat people with the disease. Eligibility: Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19. Design: Participants will be screened with a physical exam, medical history, and blood sample. Their pulse, blood pressure, and temperature will be taken. Their height and weight will be recorded. Participants will donate plasma. It will be collected through whole blood donation or through apheresis. For whole blood donation, a needle will be placed in the participant s arm vein. Blood will be withdrawn. For apheresis, a needle will be placed in the participant s arm vein. Blood will be withdrawn. A machine will separate the plasma from the red cells. The plasma will be removed, and the rest of the cells will be returned to the participant either through the same needle or through a needle in their other arm. Participants will have 3 to 20 plasma donations. Participation will last up to 3 years.

Type: Observational

Start Date: Apr 2020

open study

Following the introduction of the COVID-19 vaccination, elective surgeries have resumed, allowing for greater insight into the postoperative period and outcomes aims on-going COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity and mortality in patients who had surgery within one year of testing positive for COVID-19.

Type: Observational

Start Date: May 2020

open study

Previous studies prior to the COVID-19 pandemic show that cardiovascular and blood pressure assessment by physical therapists is inadequate or lacking despite prior training. Since the COVID-19 pandemic, assessment of cardiovascular and respiratory function may become more critical as the manifestation of long COVID has become a concern. The purpose of this study is to determine whether physical therapists' attitudes and beliefs towards vital sign assessment have changed following the COVID-19 pandemic.

Type: Observational

Start Date: Sep 2023

open study

People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.

Type: Interventional

Start Date: Aug 2022

open study

The primary goal of this study is to assess the impact of the two major disease modifying therapy (DMT) classes (B cell therapies and S1P modulators) on humoral and cell-mediated immunity to SARS- CoV-2 vaccination compared to non-MS controls. We have chosen to compare DMT-treated MS patients to non-MS controls because the pivotal vaccine studies were conducted in non-MS healthy control groups in which there is significant clinical data and validated assays for antibody responses.

Type: Observational

Start Date: Jun 2021

open study

During the study, members of different online and offline communities will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.

Type: Observational

Start Date: Jan 2021

open study

REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)

Type: Interventional

Start Date: Mar 2022

open study

This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.

Type: Interventional

Start Date: Nov 2020

open study

This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H2.

Type: Interventional

Start Date: Dec 2020

open study

The purpose of the study is to assess the effectiveness of the HALT COVID Ambassador educational outreach program on increasing likelihood to vaccinate against COVID-19

Type: Interventional

Start Date: Oct 2021

open study

This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). Messages will be sent via the electronic patient portal a few days in advance of their office visit. The primary outcome will be the rate of booster vaccination at the targeted visit. The secondary outcome will be the rate of receipt of a COVID booster vaccine within 6 weeks of the targeted visit. Subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.

Type: Interventional

Start Date: Feb 2022

open study

The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.

Type: Interventional

Start Date: Oct 2020

open study

The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.

Type: Observational

Start Date: May 2020

open study

The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19. The main question is: Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete the following activities. - Screening and first day of treatment - Treatment that will be administered for up to 10 days, two treatment evaluation visits will be completed - After treatment completion. Two visits are scheduled, one 28 days after the last dose and the other 60 days after the last dose. Researchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is Reduction in the signs and symptoms of COVID-19 at the end of treatment

Type: Interventional

Start Date: Jun 2023

open study

This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively. This study is part of the performance evaluation to support the CE conformity assessment procedures.

Type: Interventional

Start Date: Jan 2023

open study

This study is designed as a prospective, multicentric, sample collection study. The collected samples will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal and nasopharyngeal swabs by the study sponsor, Abbott.

Type: Interventional

Start Date: Mar 2022

open study

To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. Expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.

Type: Interventional

Start Date: Sep 2021

open study

This is an observational study examining the psychosocial impacts of the COVID-19 pandemic in seven low-and-middle income countries (Indonesia, Iran, Iraq, Malaysia, Pakistan, Somaliland, and Turkiye). The data was obtained on standardised measures of wellbeing (WHO Well-Being Index), psychological distress (Kessler 10), post-traumatic stress (PTSD Checklist for DSM-5), post-traumatic growth (Posttraumatic Growth Inventory), and a novel pandemic-related stress (COVID Psychosocial Impacts Scale). Data was collected employing either a unilingual (in native language) or bilingual online survey (with English as a second language) from participants (N=2574) aged 18 and above using a non-probability convenient sampling. The findings enabled us to examine the psychosocial impacts of COVID-19, validate the translations of the CPIS and standardized measures; and determine the trajectory of study variables with pandemic exposure.

Type: Observational

Start Date: Dec 2021

open study

Severe acute respiratory coronavirus 2 (SARS-CoV-2) is a novel coronavirus and the causative agent of COVID 19 disease, whose presentation symptoms range from asymptomatic infection to mild flu-like symptoms to multi system failure and death, resulting in significant morbidity and mortality worldwide. Novel vaccines against the SARS-CoV-2 virus have very recently been developed; however, the effectiveness, immune response, and short- or long-term safety of these vaccines have not been tested in immunocompromised patients on anti-CD-20 therapy for multiple sclerosis (MS) or for other disorders. This study will examine the immune response of the Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus given as standard of care (SOC) in MS patients on ocrelizumab.

Type: Observational

Start Date: Apr 2021

open study

This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.

Type: Interventional

Start Date: Nov 2020

open study

The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.

Type: Interventional

Start Date: Sep 2020

open study

This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.

Type: Expanded Access

open study

Objectives: To determine whether blockade of IL-6R is beneficial in patients with COVID-19 infection of moderate severity. Research Design: Randomized, controlled trial. Two-arm trial comparing standard care alone to standard care with addition of sarilumab (anti-IL6R). The trial will use a randomized play-the-winner design, in which randomization becomes weighted toward the arm that was more effective in previous subjects in the trial. Methodology Hospitalized patients meeting clinical criteria for moderate disease and testing positive for coronavirus infection. Interventions: sarilumab, 400 mg subcutaneous injection. Standard care is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir or hydroxychloroquine, among others. Up to 120 patients, primary outcome intubation or death within 14 days. All data will be extracted remotely from the electronic health record (EHR). Clinical Implications: The study has potential to establish IL-6R blockade, delivered subcutaneously, as standard of care in reducing progression to critical illness in patients with moderate COVID-19 disease.

Type: Interventional

Start Date: Apr 2020

open study