Active clinical trials for "COVID-19"

The current Sars-CoV-2 (COVID-19) pandemic has created major changes in how physicians perform routine healthcare for our patients, including elective and non-elective surgical procedures. Beginning on March 16th, 2020 Northwell Health postponed all elective surgeries. As the incidence of COVID-19 cases begins to decrease and hospital volume improves we need to ensure the safety of our patients planning surgical procedures. However, at this time there is a scarcity of data regarding the COVID-19 test conversion rate in surgical patients. Our goal is to determine the COVID-19 test conversion rate in these patients to better guide strategies for restarting surgical care in a large-scale pandemic. Patients will be routinely tested with serology and PCR for COVID-19 24-48 hours prior to their scheduled surgery. Those who provide informed consent will be re-tested 12-16 days after discharge from the hospital to determine any potential nosocomial infection rate. Patients will also answer a few questions during their retest to allow the study team to gauge exposure risk postoperatively after leaving the hospital.

Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.

COVID-19 caused an unprecedented international crisis. There is an urgent need for an effective regimen to cure this illness. Anecdotal data and some prospective results suggested a role of antimalarial drugs (chloroquine and hydroxychloroquine) in the treatment of this disease with best available data showing value of adding azithromycin. Based on drug repurposing studies done by our team and others, we identified the autophagy/apoptosis pathway as a major target for intervention. Based on in-silico and in-vitro models, sirolimus was identified as the drug that deserves urgent prioritization. The rational for combining sirolimus and hydroxychloroquine is explained in details in the study background below and a short video prepared by study PI (https://youtu.be/-zlOMXJp2hg). The evidence for using sirolimus for influenza is emphasized by a RCT that showed reduction of mechanical ventilation time by 50% (7 days on sirolimus arm vs 15 days on oseltamivir/steroids arm). Safe administration in human subjects is illustrated by multiple phase I/II clinical trials, performed in patients with cancer. COVID19-HOPE trial will randomize patients to 2 arms: HCQ/AZ (Arm A) and HCQ/SIR (Arm B). The main inclusion criteria is an RT-PCR test confirming infection with SARS-CoV-2 along with objective clinical criteria of disease (fever, tachypnea and/or hypoxemia). The primary endpoint of study will be Time To Clinical Improvement (TTCI), defined as time from randomization to resolution of the clinical features mentioned above (no fever, no tachypnea and no hypoxemia). In addition, secondary endpoints will include clinical failure by day 28 (need for intubation and/or death), QT interval prolongation, and adverse events. The estimated NNT based on Wilcoxon Mann Whitney comparison of TTCI in study arms is 58 patients (29 each arm). The study includes an adaptive plan, meaning that after different time points the study results will be evaluated and the NNT and randomization scheme (1:1 vs. others) will be evaluated and submitted to the IRB. Also, if one arm proves to be of no value, another regimen might be introduced based on available data. The study will recruit patients for a year and once approved by IRB and JFDA attempts to recruit other centers will be made (including national and regional centers).

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Moreover, plasma-exchange is expensive and requires large volumes of substitution fluid With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The use of plasma as a substitution fluid further increases treatment costs and is associated with risk of infections, allergic reactions and citrate-induced hypocalcemia. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. The aforementioned limitations of plasma therapy can be in part overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP)3. During DFPP, plasma is separated from cellular components by a plasma filter, and is then allowed to pass through a fractionator filter. Depending on the membrane cut-off, the fractionator filter retains larger molecules and returns fluid along with smaller molecules to the circulation. Thus, the selection of a membrane with an appropriate sieving coefficient for IgG allows to efficiently clear autoantibodies in patients with antibody-mediated diseases (e.g., macroglobulinemia, myasthenia gravis and rheumatoid arthritis) with negligible fluid losses and limited removal of albumin and coagulation factors1. In patients with severe membranous nephropathy and high titer of autoreactive, nephritogenic antibodies against the podocyte-expressed M type phospholipase A2 receptor (PLA2R), DFPP accelerated anti PLA2R depletion4. Measurement of the antibody titer in treated patient and recovered fluid showed that antibody removal was extremely effective and that large part of antibodies was removed during the first DFPP procedure. This therapeutic regimen was safe and well tolerated and easy to apply4. In an ongoing pilot study we found that the same methodological approach can be used to remove circulating antibodies from patients who recovered from COVID 19 and to infuse these antibodies in patients with active viral infection. Treatment was well tolerated and preliminary findings are encouraging. Thus, in this novel pilot study we aim to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for patients with earlier stages of coronavirus (COVID-19) pneumonia requiring oxygen supply without mechanical ventilation.

Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study is to assess whether applying prone position ventilation immediately after intubation reduces the duration of mechanical ventilation compared to prone position ventilation according to standard criteria for prone position.

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections. In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,

Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing? NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large number of samples from people with COVID-19 (as confirmed by the standard swab test used by the NHS) will enable a breath profile to be produced, ie the substances present in the breath when someone has COVID-19. After the profile has been validated, NBT can be used to test whether or not a person has COVID-19 by seeing if their breath matches the profile. Using this technology for COVID-19 testing has advantages over the current standard test. The sample can be analysed immediately in the clinical setting and the results are available in 5-10 minutes, so if the person tests negative they can go back to their normal life straight away. The current swab test takes around 72 hours for the results to be available, and the person needs to self-isolate during this time in case they test positive, resulting in potentially unnecessary days of work missed and inconvenience. The breath test is non-invasive and is unlikely to cause any discomfort, as the person is only required to breath normally into the device. This study will also review the practicalities of using this test. It is quick and easy to train people in how to carry out the test, so it could potentially easily be rolled out to testing sites.

The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).

This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.

Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.