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Covid19 clinical trials

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NCT ID: NCT04357106 Recruiting - COVID-19 Clinical Trials

COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

COPLA
Start date: April 13, 2020
Phase: Phase 2
Study type: Interventional

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

NCT ID: NCT04356833 Recruiting - COVID Clinical Trials

Nebulised Rt-PA for ARDS Due to COVID-19

PACA
Start date: April 22, 2020
Phase: Phase 2
Study type: Interventional

Some patients infected with COVID-19 require hospitalisation and develop patients a severe form of a lung disease called respiratory distress syndrome (ARDS). In these patients, the lungs become severely inflamed because of the virus. The inflammation causes fluid from nearby blood vessels to leak into the tiny air sacs in the lungs, making breathing increasingly difficult. This fluid forms small clots in the air sacs, creating a barrier until the cells regenerate. In some patients, this clot does not disappear in a timely fashion or interferes with the development of the new cells. Furthermore, the small clots in the air sacs obstruct the air and oxygen getting deep into the lungs, interfering with proper ventilation. The trial will recruit patients with COVID-19 induced ARDS. Eligible patients (or if patients lack capacity, their legal representative) will be provided with an information sheet and informed consent will be sought. Eligibility will be mainly assessed via routine clinical assessments. Patients will receive a nebulised version of a type of drug called tissue plasminogen activator (rt-PA) that is inhaled using a nebuliser. This is normally a drug used to break down blood clots. In this situation though, it might be useful for stopping clots forming in the lungs, because these might lead to even more difficulties with breathing. The study will run two cohorts sequentially. In cohort 1, 9 consented patients received nebulised rtPA in addition to SOC. 6 patients were receiving IMV and 3 were receiving non invasive support with NIV or CPAP or high flow oxygen or standard oxygen therapy. As an observational arm, matched historical controls who received standard of care were also recruited at a ratio of 2 controls to every 1 treatment arm patient, resulting in 18 historical controls. Originally, the study aimed to recruit 12 patients with 6 on each ventilation type (IMV and non-invasive oxygen support). This would have resulted in 24 historical controls. After the first wave of COVID-19 cases decreased in August 2020 in the UK it became difficult to continue recruitment, so recruitment closed for cohort 1. With a second surge underway in early 2021, cohort 2 will aim to recruit more patients during this period to provide more data on the safety of rtPA. Fewer timepoints will be collected, which will allow for more rapid recruitment while at the same time not compromising safety monitoring. A more flexible dosing regimen for rtPA will be utilised. 30 patients will be recruited in total, with an aim to recruit a minimum of 10 IMV patients and 10 patients on non-invasive oxygen support. To evaluate efficacy, the improvement of oxygen levels over time and safety will be be monitored throughout. Blood samples will be taken to measure markers of clotting and inflammation in both groups. From the end of the treatment phase both groups will be followed up in accordance with SOC for 28 days from the day of first dose of rtPA.

NCT ID: NCT04356482 Recruiting - COVID-19 Clinical Trials

CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19

COPLASCOV19
Start date: May 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?

NCT ID: NCT04356443 Recruiting - COVID-19 Clinical Trials

Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection

Start date: April 15, 2020
Phase:
Study type: Observational

This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

NCT ID: NCT04355624 Recruiting - COVID Clinical Trials

Kidney Involvement in COVID-19 Disease (COVKID)

COVKID
Start date: April 15, 2020
Phase:
Study type: Observational

Novel coronavirus disease (COVID-19) is a newly discovered contagious disease caused by SARS-CoV-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. In previous reports of SARS and MERS-CoV infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). Recent reports showed renal abnormalities in COVID-9 infected patients. A recent Chinese study also reported that acute kidney injury was an independent risk factor for mortality. However, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. Also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone. A recent study identified viral RNA in kidney tissue and another study succeeded isolating SARS-CoV-2 from the urine sample of an infected patient. These data suggest that the kidney might be a target of this novel coronarivus. The sponsor suggests characterizing kidney involvement in SARS-CoV-2 infection. Study objectives are: - To give an accurate characterization of kidney involvement in COVID-19 - To investigate the physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection - To identify risk factors for kidney involvement in in SARS-CoV-2 infection - To evaluate the impact of kidney involvement in in SARS-CoV-2 infection - To assess the long-term health effect of kidney injury on survivors of in SARS-CoV-2 infection

NCT ID: NCT04355481 Recruiting - Covid-19 Clinical Trials

Dissemination of SARS-COV-2 (COVID-19) in the Environment of Infected Patients Admitted to Intensive Care Unit

ENVIROREA
Start date: April 17, 2020
Phase:
Study type: Observational

The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

NCT ID: NCT04355247 Recruiting - Covid-19 Clinical Trials

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Start date: April 14, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.

NCT ID: NCT04355052 Recruiting - COVID - 19 Clinical Trials

Open Label Study to Compare Efficacy, Safety and Tolerability of Hydroxychloroquine Combined With Azithromycin Compared to Hydroxychloroquine Combined With Camostat Mesylate and to "no Treatment" in SARS CoV 2 Virus

COSTA
Start date: April 11, 2020
Phase: Phase 3
Study type: Interventional

Patients with COVID-19 which are 60 years old or above or with comorbidities are at risk of deteriorating and developing severe illness. This prospective open label study will include people 60 years old or above or younger if at risk for severe disease. Individuals confirmed to have SARS-CoV-2 infection will be identified using medical records screening. They will then be offered to participate in the study and if agree will be given the informed consent. After examining inclusion and exclusion criteria they will be asked to sign the informed consent and after signing Information like immunizations, ECG results, diagnostic images and reports, written medical reports, diagnostic lab testing results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug and food allergies, food intolerances), prescription history, and general patient information (e.g. name, birthdate, personal health number, address, phone number) will be gathered. Those who are not eligible for the study will be informed of the reason(s) for ineligibility (generally it will be a safety exclusion and they should be aware of this). Those who are eligible will be randomized to one of three arms: hydroxychloroquine + azithromycin, hydroxychloroquine + camostat mesylate or "doing nothing" in a ratio of 2:1:2. Study drug will be dispensed by the hospital pharmacy. Follow up will continue for 8 weeks.

NCT ID: NCT04355026 Recruiting - Covid-19 Clinical Trials

Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia

Start date: April 10, 2020
Phase: Phase 4
Study type: Interventional

In the current situation it is of great importance to discover a safe, cost-effective and available treatment strategy in order to limit the rapidly spreading SARS-Cov-2. Recent studies have shown that hydroxychloroquine could have a role in the treatment of infected patients. It is however not very likely that hydroxychloroquine alone could be adequate for treatment of Covid-19 disease. Effective therapy that prevents the virus entrance should contain at least TMPRSS2 inhibitor or a competitive inhibitor of viral ACE 2 binding. The use of bromhexine at the dose adequate to selectively inhibit the TMPRSS2, resulting in preventing of viral entrance via TMPRSS2-specific pathway, coud be an effective treatment of Covid-19. In our study we would like to explore the therapeutic potential of bromhexin and hydroxychloroquine in Covid-19 patients. Hypothesis 1. Combined treatment with bromhexin and hydroxychloroquine shortens the course of disease in hospitalized Covid-19 patients compared to hydroxychloroquine alone. 2. Combined treatment with bromhexin and hydroxychloroquine lowers the incidence of secundary pulmonary infections in hospitalized Covid-19 patients compared to hydroxychloroquine alone. 3. Combined treatment with bromhexin and hydroxychloroquine decreases the need for ICU admission in hospitalized Covid-19 patients compared to hydroxychloroquine alone.

NCT ID: NCT04354558 Recruiting - Sars-CoV2 Clinical Trials

French Single Centre Experience of Critically Ill Patients With Covid 19

CovidAmiens20
Start date: July 1, 2020
Phase:
Study type: Observational

Since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS). In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU). the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2