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NCT ID: NCT04372121 Terminated - Endometriosis Clinical Trials

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain

EDELWEISS 5
Start date: March 23, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

NCT ID: NCT04372017 Terminated - COVID-19 Clinical Trials

Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

Start date: May 14, 2020
Phase: Phase 3
Study type: Interventional

This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.

NCT ID: NCT04371666 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)

LELANTOS-1
Start date: August 10, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in participants with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).

NCT ID: NCT04371393 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

MSCs in COVID-19 ARDS

Start date: April 30, 2020
Phase: Phase 3
Study type: Interventional

The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

NCT ID: NCT04370834 Terminated - Pneumonia Clinical Trials

Tocilizumab for Patients With Cancer and COVID-19 Disease

Start date: May 28, 2020
Phase: Phase 2
Study type: Interventional

This phase II expanded access trial will study how well tocilizumab works in reducing the serious symptoms including pneumonitis (severe acute respiratory distress) in patients with cancer and COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. COVID-19 can be associated with an inflammatory response by the immune system which may also cause symptoms of COVID-19 to worsen. This inflammation may be called "cytokine storm," which can cause widespread problems in the body. Tocilizumab is a medicine designed to block the action of a protein called interleukin-6 (IL-6) that is involved with the immune system and is known to be a key factor for problems with excessive inflammation. Tocilizumab is effective in treating "cytokine storm" from a type of cancer immunotherapy and may be effective in reducing the inflammatory response and "cytokine storm" seen in severe COVID-19 disease. Treating the inflammation may help to reduce symptoms, improve the ability to breathe without a breathing machine (ventilator), and prevent patients from having more complications.

NCT ID: NCT04370236 Terminated - COVID-19 Clinical Trials

INB03 for the Treatment of Pulmonary Complications From COVID-19

Start date: October 21, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

NCT ID: NCT04369989 Terminated - COVID-19 Clinical Trials

Observational Study of COVID-19 Treatment Efficacy

Start date: April 14, 2020
Phase:
Study type: Observational

To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.

NCT ID: NCT04369742 Terminated - COVID-19 Clinical Trials

Treating COVID-19 With Hydroxychloroquine (TEACH)

Start date: April 15, 2020
Phase: Phase 2
Study type: Interventional

Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.

NCT ID: NCT04369638 Terminated - Clinical trials for Cleft Lip and Palate

Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan

Start date: January 27, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to fabricate a nasoalveolar molding (NAM) appliance that is digitally fabricated and 3 dimensionally printed utilizing an MRI face scan and to assess the fit of the NAM in new borns with cleft lip and palate.

NCT ID: NCT04369469 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

Start date: May 10, 2020
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.