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Coronavirus Infections clinical trials

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NCT ID: NCT04466241 Recruiting - COVID-19 Clinical Trials

Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial

INTENSE-COV
Start date: November 27, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

In January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO has described the global situation of COVID-19 as a pandemic. In Côte d'Ivoire, as in other African countries, the number of cases is increasing exponentially. Coronaviruses are a family of viruses that cause illnesses ranging from the common cold to more severe pathologies. COVID-19 can result in fever or a feeling of fever (chills, hot-cold), cough, headache, aches and pains, unusual tiredness, sudden loss of smell, total disappearance of taste, or diarrhea. In severe forms, respiratory difficulties can lead to hospitalization in intensive care or even death. Numerous studies are currently being conducted around the world to seek effective treatment, but few of them have started specifically in Africa. Moreover, most of these studies are using a single drug to control the infection, whether these are repositioned drugs, i.e. already being used for other diseases, or other newer drugs. Currently in Côte d'Ivoire, the preferred treatment for COVID-19 is an antiviral: lopinavir/ritonavir (LPV/r), usually directed against the Human Immunodeficiency Virus (HIV). Since the number of viruses (viral load) is high in the respiratory tract during COVID-19 infection, we propose in INTENSE-COV (ICOV) clinical trial to study whether the combination of two drugs is more effective than taking a single drug on reducing the viral load in the respiratory tract but also on reducing inflammation. These drugs include the LPV/r already in use in Côte d'Ivoire as well as an antihypertensive drug - telmisartan, and a drug that lowers blood cholesterol - atorvastatin. All three have been known for a long time and have been shown to be effective against other viruses. In addition, they are generic, inexpensive and readily available in all countries. The objectives of the ICOV study are therefore to improve viral eradication from the patient's body and respiratory tract, to reduce inflammation, to improve more rapidly the patient's state of health and to reduce the risk of transmission of the virus to others. To participate in ICOV, patients must be over 18 years of age, have a COVID-19 infection confirmed by a specific test, have clinical manifestations of the infection, and have signed an informed consent. They will then be randomized into 3 treatment groups to ensure the robustness of the study results. The reference group will be treated with LPV/r, according to current recommendations in Côte d'Ivoire. The other 2 groups will be treated with LPV/r + telmisartan and LPV/r + atorvastatin respectively. The treatment will last 10 days and patients will be followed for a total of 28 days.

NCT ID: NCT04466085 Active, not recruiting - Coronavirus Clinical Trials

Clinical Study of Recombinant Novel Coronavirus Vaccine

Start date: July 12, 2020
Phase: Phase 2
Study type: Interventional

A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.

NCT ID: NCT04465552 Completed - Clinical trials for Coronavirus Infections

Arrhythmic Manifestations and Management in Hospitalized COVID-19 Patients

Start date: July 10, 2020
Phase:
Study type: Observational

Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.

NCT ID: NCT04464460 Withdrawn - Coronavirus Disease Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of TAK-671 for the Treatment of Coronavirus Disease (COVID) 2019 in Adults

Start date: September 25, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.

NCT ID: NCT04462848 Not yet recruiting - Clinical trials for Corona Virus Infection

Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

Start date: August 2020
Phase: Phase 1
Study type: Interventional

This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

NCT ID: NCT04462367 Active, not recruiting - COVID19 Clinical Trials

Northeast COVID-19 and Pregnancy Study Group

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

A prospective and retrospective cohort study. The objective will to determine the frequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate clinical and laboratory predictors of COVID-19 progression and to determine the factors associated with adverse maternal and perinatal outcomes in healthcare centers in two states of Northeast Brazil.The study will be conducted including pregnant and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be included. The data will be collected in specific forms. The exams will be carried out by trained professionals within each institution.

NCT ID: NCT04461379 Active, not recruiting - COVID-19 Clinical Trials

Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers

Start date: July 21, 2020
Phase: Phase 3
Study type: Interventional

In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability to contain the disease. There is currently no vaccine to prevent the disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant mortality has been reported, not related only to tuberculosis. BCG vaccine has been hypothesized to have a non-specific role towards other unrelated pathogens such as viruses that cause airway disease, with reduced morbidity and mortality. In murine as well as in human models it has been shown to decrease the incidence of acute respiratory influenza infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it increases the epigenetic response, causing an increase in the transcription of genes important in the antimicrobial response, as well as an improvement in cellular function. This is the first national clinical trial to evaluate prospectively the effect that the BCG vaccine offers towards the prevention and reduction of severity in cases of COVID-19.

NCT ID: NCT04461353 Completed - Clinical trials for Severe Acute Respiratory Syndrome Coronavirus 2

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers

Start date: June 25, 2020
Phase: Phase 1
Study type: Interventional

This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: - To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. - To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.

NCT ID: NCT04459702 Withdrawn - COVID-19 Clinical Trials

A Study of Combination Therapies to Treat COVID-19 Infection

Start date: July 2020
Phase: Phase 2
Study type: Interventional

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

NCT ID: NCT04459403 Completed - Clinical trials for Corona Virus Infection

Psychiatric Disturbances and COVID-19 Infection

Start date: June 8, 2020
Phase:
Study type: Observational

This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied