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Covid19 clinical trials

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NCT ID: NCT05279365 Recruiting - COVID-19 Clinical Trials

PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS

Start date: July 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". There is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-SARS-CoV-2 antibodies, is responsible (partially or wholly) for this reinfection. In this study, we intend to give a booster does Pfizer/BioNTech and/or Moderna and ascertain the levels of antibodies at various times pre and post vaccination. The incidence of infection with SARS-CoV-2 after booster vaccination will also be obtained.

NCT ID: NCT05279352 Recruiting - COVID-19 Clinical Trials

Safety and Pharmacokinetics of FBR-002 for the Treatment of Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome

Start date: March 21, 2022
Phase: Phase 2
Study type: Interventional

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the coronavirus associated with COVID-19 (Coronavirus Disease 2019), invading the respiratory tract, and leading to symptoms from dysgeusia, anosmia, fever, headache and cough to dyspnea and severe respiratory failure and even death. In order to obtain its pathogenic activity, the SARS-CoV-2 relies on its spike protein to enter the cells of the infected patient. This infection leads to a variable severity spectrum, with the majority of forms of mild entity (upper respiratory tract infection or lower respiratory tract without respiratory failure or insufficiency of other organs) despite the presence of a considerable share of severe infections in need hospitalization in sub-intensive or intensive area (up to 6% of cases) with invasive and non-invasive respiratory support. Approximately 14% of patients have experienced severe disease and 5% have been critically ill. In the context of global pandemic, Fab'entech is currently developing polyclonal F(ab')2 equine fragments directed against the SARS-CoV-2 spike protein. Indeed, as virus entry within the cell requires this protein, Fab'entech proposes a way to block this event, neutralizing viral replication, and therefore inhibiting pathogenic activity of the virus. The objective of this two-stage randomized, placebo-controlled, double blind, phase 2a study is to characterize the safety and pharmacokinetics of FBR-002 in patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome

NCT ID: NCT05278390 Recruiting - Clinical trials for Respiratory Failure With Hypoxia

Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic

QUANTICO-PRO
Start date: June 13, 2022
Phase: N/A
Study type: Interventional

Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example. This study aims at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure.

NCT ID: NCT05277324 Recruiting - Skin Condition Clinical Trials

The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic

Start date: March 7, 2022
Phase:
Study type: Observational

The global coronavirus disease pandemic (COVID-19) has led to an increased need to wear protective equipment such as wearing face masks and practicing hygiene measures such as more frequent use of antiseptics. These measures can lead to changes in the skin, the development of new inflammatory skin diseases or exacerbation of existing ones, with health professionals especially under the risk of developing these changes. Changes in facial skin due to wearing masks have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged masks' use have not been investigated. The aim of these study was to investigate the effects of constant, long-term use of protective masks on facial skin.

NCT ID: NCT05277285 Recruiting - COVID-19 Clinical Trials

STS Administration on Coronavirus Disease (COVID-19) Patients in Critical Care

H4COVID
Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose is to describe the safety of administration of three doses of STS to critically ill patients with confirmed COVID-19. A secondary purpose is to describe data on the clinical efficacy of administration of up to three doses of STS in critically ill patients with confirmed COVID-19.

NCT ID: NCT05277155 Recruiting - COVID-19 Clinical Trials

Trial to Study the Efficacy and Safety of BEJO Red Ginger in COVID-19 Patients With Mild Symptoms

Start date: February 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of BEJO Red Ginger in hospitalized adult (18 - 50 years old) COVID-19 patients with mild clinical manifestations. Subjects will be screened during hospitalization. One hundred and sixty-eight patients with confirmed SARS-CoV-2 infection and meeting all criteria, will be recruited to receive either BEJO Red Ginger or placebo in addition to standard of care (SOC) in a 1:1 ratio. Patients with a diagnosis of COVID-19 and, due to mild symptoms, hospitalized, will be randomized to take a sachet of syrups containing 15 ml of BEJO Red Ginger, 3 times a day: 1 sachet after breakfast, 1 sachet after lunch, and 1 sachet after dinner, as add-on to the SOC, with 2 hours of incubation of SOC. The treatment will last for 14 days or until patients to be declared as cured. The treated patients will be compared with an equal group treated with placebo and SOC. Recovery time, symptoms, and objective (inflammatory) parameters (see detailed description) will be analyzed as outcomes. The goal of this study is to evaluate the role of BEJO Red Ginger in preventing progression of COVID-19 and accelerating healing process in patients.

NCT ID: NCT05276375 Recruiting - COVID-19 Clinical Trials

Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19

BroVID
Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

There is currently an urgent need for effective and safe treatments of Coronavirus Disease (COVID) - 19 and the cytokine storm that is responsible for the development of patient's Acute Respiratory Distress Syndrome (ARDS). As Bronchipret has been proven to be a very safe medicine, it is not expected that it would lead to the development of severe adverse effects in COVID-19 patients. Bronchipret can therefore be recommended as effective and safe supplementary treatments of COVID-19, even more so considering the positive effects shown in vitro. Thus, this randomized study is conducted to assess the effect of Bronchipret on the immune response and recovery in patients with mild COVID-19 by assessing several blood parameters as well as the symptom recovery and improvement in comparison to patients who do not receive Bronchipret. Another aim of this feasibility study is to determine the best possible primary endpoint, i.e. which shows the greatest effect according to Cohen.

NCT ID: NCT05276102 Recruiting - Irritation/Irritant Clinical Trials

The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

The global coronavirus disease pandemic (COVID-19) has led to an increased need to wear protective equipment such as wearing face masks and practicing hygiene measures such as more frequent use of antiseptics. These measures can lead to changes in the skin, the development of new inflammatory skin diseases or exacerbation of existing ones, with health professionals especially under the risk of developing these changes. Changes in the skin of the hands due to the use of antiseptics have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment of researchers, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged use of antiseptics and the impact of measures to prevent and protect against irritation such as topical application of emollient preparations have not been investigated. The impact of repeated use of antiseptics in the repeated exposure model on the forearms will be investigated. This model is a modification of the existing model of irritative dermatitis induced by sodium lauryl sulfate where the original irritant was replaced by an antiseptic solution.

NCT ID: NCT05273541 Recruiting - COVID-19 Clinical Trials

Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer

Start date: February 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has caused a global pandemic since late 2019 that resulted in more than 360 million population infection. Patients with cancers may be at higher risk of infection and severity than those without cancer. Mass vaccination has been carried out, but reinfection and vaccine breakthrough cases still occur. Now, the prime-boost regimen was identified safe and efficient, but the reactogenicity and immunogenicity of prime-boost vaccine strategy in cancer patients were not known.

NCT ID: NCT05273242 Recruiting - COVID-19 Clinical Trials

Add-on Study on WHO Solidarity Trial Plus for COVID-19 in Nepal

Start date: December 6, 2021
Phase: Phase 4
Study type: Interventional

Proposal for Sub-Study to be conducted with the WHO Solidarity Plus Trial: Apart from the data been collected as per the WHO Solidarity Trial Plus protocol, Nepal Health Research Council will conduct a sub-study to evaluate some components which are felt to be important in the local context but have not been included as part of the Solidarity Trial Plus. Rather that conducting a separate study, the following components can be evaluated by collecting additional data as a part of sub-study in the local context.