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NCT ID: NCT04680637 Terminated - Clinical trials for Active Systemic Lupus Erythematosus

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

NCT ID: NCT04642638 Terminated - Clinical trials for Coronavirus Infection

Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure

Start date: November 30, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.

NCT ID: NCT04633187 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Who Are Infected With Acute Respiratory Syncytial Virus (RSV) of the Upper Respiratory Tract

RSVTx
Start date: July 7, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

NCT ID: NCT04605159 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

GRACE
Start date: November 20, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.

NCT ID: NCT04602507 Terminated - Covid19 Clinical Trials

Ivermectin in Adults With Severe COVID-19.

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

Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications. Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation. An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers. Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease. Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.

NCT ID: NCT04583423 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)

Start date: November 11, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

NCT ID: NCT04575584 Terminated - Clinical trials for Coronavirus Disease (COVID-19)

Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

Start date: October 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.

NCT ID: NCT04547140 Terminated - COVID-19 Clinical Trials

Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)

Start date: January 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.

NCT ID: NCT04539873 Terminated - Clinical trials for Corona Virus Infection

Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

(COLCOVID19)
Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days

NCT ID: NCT04439071 Terminated - COVID-19 Clinical Trials

A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)

FITE19
Start date: July 9, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.