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Coronavirus Infections clinical trials

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NCT ID: NCT04345289 Terminated - COVID Clinical Trials

Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia

CCAP
Start date: May 1, 2020
Phase: Phase 3
Study type: Interventional

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

NCT ID: NCT04344977 Completed - Clinical trials for Coronavirus Disease 2019 (COVID-19)

Collection of Anti-SARS-CoV-2 Immune Plasma

NIAID
Start date: June 1, 2020
Phase:
Study type: Observational

Background: The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19. Researchers want to collect plasma from adults who have recovered from COVID-19, which may help them develop treatments. Objective: To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19. Eligibility: Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study. Design: This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part alone (either screening or plasma collection only) or both parts (screening and plasma collection). For screening part: Participants will be screened for their eligibility to join this research study with a medical history and physical exam. Their vital signs (blood pressure, heart rate, temperature, respiration rate) will be taken. Their weight and height will be recorded. They will give a blood sample for clinical laboratory tests of their general health and a research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate plasma. For plasma collection part: Subjects meeting criteria for plasma donation and found to have high neutralizing antibody titers and who plan to donate plasma under this part of the study will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less than 7 days apart. Prior to each donation, participants will have a brief physical exam and complete a donor history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms. At each donation, plasma will be taken through a standard apheresis procedure. For this, blood will be withdrawn through a needle placed in the participant's arm vein. A machine will separate the plasma from the red cells. The red cells will be returned to the participant, either through the same needle or through a second needle in the other arm. Participation may last up to 240 days.

NCT ID: NCT04344106 Recruiting - Clinical trials for Coronavirus Infection

Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study

ProCov
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

NCT ID: NCT04344041 Completed - Coronavirus Clinical Trials

COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)

Start date: April 15, 2020
Phase: Phase 3
Study type: Interventional

Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator. In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths. Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS). Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections. High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status. Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now. We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

NCT ID: NCT04343898 Completed - Clinical trials for Coronavirus Infection

Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

STOP-COVID
Start date: April 1, 2020
Phase:
Study type: Observational

Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

NCT ID: NCT04343651 Completed - Clinical trials for Coronavirus Disease 2019

Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

NCT ID: NCT04343261 Completed - COVID Clinical Trials

Convalescent Plasma in the Treatment of COVID 19

Start date: April 10, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

NCT ID: NCT04342728 Completed - COVID Clinical Trials

Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation

COVIDAtoZ
Start date: April 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.

NCT ID: NCT04342663 Completed - Coronavirus Clinical Trials

A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

STOP COVID
Start date: April 10, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.

NCT ID: NCT04342195 Completed - COVID-19 Clinical Trials

Acquiring Convalescent Specimens for COVID-19 Antibodies

Start date: March 25, 2020
Phase:
Study type: Observational

Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.